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| Name | Class |
|---|---|
| FGK Clinical Research GmbH | INDUSTRY |
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Post-market, observational study to collect prospective data related to the safety and performance of the Power PICC family of devices and its accessories in a real-world setting.
Single-arm, post-market, observational, prospective study to asses the safety and performance of the Power PICC Power PICC family of devices and its accessories in a real-world setting. The study will only enroll patients that need a Power PICC catheter as part of their medical care. Patients will be followed from insertion through removal, or up to 180 days (whichever comes first). Data collected will be gathered from the patient's medical chart.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All subjects | patients who require a PICC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peripherally Inserted Central Catheter | Device | insertion of a Peripherally Inserted Central Catheter (PICC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety: Incidence of Symptomatic Venous Thrombosis in Patients With a Device From the BD PowerPICC Family Used for Both Short- and Long-term Venous Access. | Incidence of symptomatic venous thrombosis defined as any new occurrence of symptomatic venous thrombosis defined by thrombus presence by ultrasonography or other imaging. | from insertion though removal or 180 days, whichever comes first |
| Primary Performance: Percent of PICCs That Remain in Place Through the Required Therapy Time Period. | PICCs remaining in place through the required therapy time period were defined as PICCs that were either still in place at the end of the 180-day observation or had been removed because the therapy was completed (end of useful medical use), changed or cancelled. Most patients who died during the study had the device still in place at the time of death and hence were considered as having completed the therapy. | from insertion though removal or 180 days, whichever comes first |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Safety: Incidence of Phlebitis | Incidence of phlebitis where phlebitis is defined inflammation of the cannulated vessel identified by redness, swelling, warmth, tenderness, and/or cord formation | from insertion though removal or 180 days, whichever comes first |
| Secondary Safety: Incidence of Extravasation |
| Measure | Description | Time Frame |
|---|---|---|
| Usability: Ease of Insertion When the Sherlock 3CG Pre-Loaded Stylet Used | The percentage of Sherlock 3CG Pre-Loaded Stylet that aided in guidance and placement of the catheter, when used | during the insertion procedure |
Inclusion Criteria:
Exclusion Criteria:
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Any patients who require a PICC device in a primary care facility.
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| Name | Affiliation | Role |
|---|---|---|
| Klaus Hoerauf, MD | Becton, Dickinson and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Klagenfurt | Klagenfurt | Austria | ||||
| Medizinische Universität Wien |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39349374 | Derived | Troubil M, Capozzoli G, Mussa B, Hodne M, Hoerauf K, Alsbrooks K. Performance and safety of PowerPICC catheters and accessories: a prospective observational study. BMJ Open. 2024 Sep 30;14(9):e081288. doi: 10.1136/bmjopen-2023-081288. |
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In this post market study, 450 patients, who were to receive a PICC from the PowerPICC family as per routine clinical practice, were observed for up to 180 days after device's insertion or until removal of the device because the therapy was completed, changed or cancelled. Patients, who died during the study and had the device in place at the time of death, were considered as having completed the therapy.
The study was conducted at 14 centers in 9 European countries. The first participant was enrolled on June 18, 2020 and the last participant had the last study visit on January 05, 2022.
The choice of the specific device type, size, number of lumens, and length required for an individual patient was left to the discretion of the clinician.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Subjects | Patients who received a device from the BD PowerPICC family according to the clinical practice. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 12, 2019 | Jul 24, 2023 |
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Incidence of extravasation where extravasation is defined as accidental infiltration of a vesicant or chemotherapeutic drug into the tissue around the catheter |
| from insertion though removal or 180 days, whichever comes first |
| Secondary Safety: Incidence of Local Infection | Incidence of any new occurrence of local infection | from insertion though removal or 180 days, whichever comes first |
| Secondary Safety: Incidence of Local Infection as Presence of Pus at the Exit Site and/or Culture Confirmed Site Infection | Incidence of local infection where local infection is defined as presence of pus at the exit site and/or culture confirmed site infection | from insertion though removal or 180 days, whichever comes first |
| Secondary Safety: Incidence of Catheter-related Bloodstream Infection. | Incidence of Catheter-related bloodstream infection where Catheter-related bloodstream infection is defined as positive blood culture(s) with a microorganism not related to another source (e.g., UTI) OR positive blood culture(s) with microorganism matching catheter tip culture OR blood cultures from peripheral venous puncture and PICC positive with the same microorganism. | from insertion though removal or 180 days, whichever comes first |
| Secondary Safety: Incidence of Accidental Dislodgement. | Incidence of Accidental dislodgement where Accidental dislodgement is defined as catheter accidentally dislodged the extent to which it requires replacement. | from insertion though removal or 180 days, whichever comes first |
| Secondary Safety: Incidence of Vessel Laceration. | Incidence of vessel laceration where vessel laceration is defined as a tear in the tissue of the vessel. | from insertion though removal or 180 days, whichever comes first |
| Secondary Safety: Incidence of Vessel Perforation. | Incidence of vessel perforation where vessel perforation is defined as a hole formed in the vessel. | from insertion though removal or 180 days, whichever comes first |
| Secondary Performance: Percent of Patent Catheters | Percent of patent catheters defined as the number of functional catheters through therapy/total number of catheters. | from insertion though removal or 180 days, whichever comes first |
| Secondary Performance: Percent of Placement Success in Single Insertion Attempt | Percent of placement success in single insertion attempt defined as placement success defined as single insertion attempt, proper tip location, and patent catheter | during the insertion procedure |
| Secondary Performance - Usability: Ease of Insertion | Ease of insertion determined by composite score of guidewire/stylet performance based on post-insertion survey (5 point Likert scale) | during the insertion procedure |
| Vienna |
| A-1090 |
| Austria |
| University Hospitals KU Leuven | Leuven | B-3000 | Belgium |
| Fakultní nemocnice Olomouc | Olomouc | Czechia |
| Sygehus Soenderjylland, Sønderborg | Sønderborg | 6400 | Denmark |
| Universitätsklinikum Jena | Jena | Germany |
| Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo | Alessandria | Piedmont | 15121 | Italy |
| Ospedale Civile di Ivrea | Ivrea | Piedmont | 10015 | Italy |
| A.O.U Città della Salute e della Scienza Torino, Ospedale Molinette | Turin | Piedmont | 10126 | Italy |
| Ospedale Centrale di Bolzano | Bolzano | Trentino-Alto Adige | 39100 | Italy |
| Azienda Ospedaliera dei Colli - Monaldi | Naples | Italy |
| HAGA Ziekenhuis | The Hague | 2545 | Netherlands |
| Hospital Universitari de Girona Dr Josep Trueta | Girona | Spain |
| Institut für Diagnostische und Interventionelle Radiologie | Zurich | 8091 | Switzerland |
|
| Receive Treatment Via the Study Device |
|
| COMPLETED | In the end of eCRF study form, 335 patients were documented as having completed the therapy via study device (device either removed because therapy was completed, changed, or cancelled or still in place at 180 days) and 115 patients were documented as non-completed. |
|
| NOT COMPLETED |
|
|
Patients who underwent placement of a study device.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | Patients who received a device from the BD PowerPICC family according to the clinical practice. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The patients' age ranged from 6 to 96 years with a median age of 62.0 years. | Mean | Standard Deviation | years |
| |||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m² |
| ||||||||||||||||||||||
| Relevant medical history | Count of Participants | Participants |
| |||||||||||||||||||||||
| Primary diagnosis for current admission | Count of Participants | Participants |
| |||||||||||||||||||||||
| Reason for PICC placement | A subject may report more than 1 reason for PICC placement. | Number | participants |
| ||||||||||||||||||||||
| Intended access duration | Count of Participants | Participants |
| |||||||||||||||||||||||
| Catheter insertion - Location of procedure performance | Count of Participants | Participants |
| |||||||||||||||||||||||
| Catheter insertion - Catheter tip repositioning | Count of Participants | Participants |
| |||||||||||||||||||||||
| Catheter insertion - Device placement successful | Count of Participants | Participants |
| |||||||||||||||||||||||
| Catheter insertion - Placement of catheter | Count of Participants | Participants |
| |||||||||||||||||||||||
| Catheter insertion - Vein accessed | Count of Participants | Participants |
| |||||||||||||||||||||||
| Catheter insertion - Vessel/catheter ratio done prior to insertion | Count of Participants | Participants |
| |||||||||||||||||||||||
| Catheter insertion - Number of insertion attempts | Count of Participants | Participants |
| |||||||||||||||||||||||
| Catheter insertion - Local anesthesia used | Count of Participants | Participants |
| |||||||||||||||||||||||
| Catheter insertion - Catheter length trimmed | Count of Participants | Participants |
| |||||||||||||||||||||||
| Catheter insertion - Tunneling used | Count of Participants | Participants |
| |||||||||||||||||||||||
| Catheter insertion - Sherlock TLS used | Count of Participants | Participants |
| |||||||||||||||||||||||
| Catheter insertion - Sherlock 3CG used | Count of Participants | Participants |
| |||||||||||||||||||||||
| Catheter insertion - Method to confirm catheter tip positioning | Count of Participants | Participants |
| |||||||||||||||||||||||
| Catheter insertion - Stabilization method | Count of Participants | Participants |
| |||||||||||||||||||||||
| Catheter insertion - Dressing type | Count of Participants | Participants |
| |||||||||||||||||||||||
| Catheter insertion - PICC insertion as per Instructions For Use (IFUs) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Catheter insertion - presence of a second implanted line vascular access device | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Primary Safety: Incidence of Symptomatic Venous Thrombosis in Patients With a Device From the BD PowerPICC Family Used for Both Short- and Long-term Venous Access. | Incidence of symptomatic venous thrombosis defined as any new occurrence of symptomatic venous thrombosis defined by thrombus presence by ultrasonography or other imaging. | Since the study device could not be placed in 2 patients and in 1 patient the study device was placed but could not be used for the intended treatment, these 3 subjects were excluded from the denominator for safety variable. Therefore, 447 out of 450 subjects have been considered for denominator calculation. | Posted | Number | 95% Confidence Interval | % of subjects after PICC placement | from insertion though removal or 180 days, whichever comes first |
|
|
| |||||||||||||||||||||||||
| Primary | Primary Performance: Percent of PICCs That Remain in Place Through the Required Therapy Time Period. | PICCs remaining in place through the required therapy time period were defined as PICCs that were either still in place at the end of the 180-day observation or had been removed because the therapy was completed (end of useful medical use), changed or cancelled. Most patients who died during the study had the device still in place at the time of death and hence were considered as having completed the therapy. | A total of 447 patients received treatment via the study device and were included in the evaluable set, used for the primary performance calculation. The percentage of PICCs that remains in place through the completion of therapy (success) was calculated by dividing successful cases by the total number of devices with non-missing data on success/failure.Therefore, 2 subjects lost to follow-up were not included in the calculation of percentage. | Posted | Number | 95% Confidence Interval | % of subjects after PICC placement | from insertion though removal or 180 days, whichever comes first |
|
| ||||||||||||||||||||||||||
| Secondary | Secondary Safety: Incidence of Phlebitis | Incidence of phlebitis where phlebitis is defined inflammation of the cannulated vessel identified by redness, swelling, warmth, tenderness, and/or cord formation | Since the study device could not be placed in 2 patients and in 1 patient the study device was placed but could not be used for the intended treatment, these 3 subjects were excluded from the denominator for safety variable. Therefore, 447 out of 450 subjects have been considered for denominator calculation. | Posted | Number | 95% Confidence Interval | % of subjects after PICC placement | from insertion though removal or 180 days, whichever comes first |
|
| ||||||||||||||||||||||||||
| Secondary | Secondary Safety: Incidence of Extravasation | Incidence of extravasation where extravasation is defined as accidental infiltration of a vesicant or chemotherapeutic drug into the tissue around the catheter | Since the study device could not be placed in 2 patients and in 1 patient the study device was placed but could not be used for the intended treatment, these 3 subjects were excluded from the denominator for safety variable. Therefore, 447 out of 450 subjects have been considered for denominator calculation. | Posted | Number | 95% Confidence Interval | % of subjects after PICC placement | from insertion though removal or 180 days, whichever comes first |
|
| ||||||||||||||||||||||||||
| Secondary | Secondary Safety: Incidence of Local Infection | Incidence of any new occurrence of local infection | Since the study device could not be placed in 2 patients and in 1 patient the study device was placed but could not be used for the intended treatment, these 3 subjects were excluded from the denominator for safety variable. Therefore, 447 out of 450 subjects have been considered for denominator calculation. | Posted | Number | 95% Confidence Interval | % of subjects after PICC placement | from insertion though removal or 180 days, whichever comes first |
|
| ||||||||||||||||||||||||||
| Secondary | Secondary Safety: Incidence of Local Infection as Presence of Pus at the Exit Site and/or Culture Confirmed Site Infection | Incidence of local infection where local infection is defined as presence of pus at the exit site and/or culture confirmed site infection | Since the study device could not be placed in 2 patients and in 1 patient the study device was placed but could not be used for the intended treatment, these 3 subjects were excluded from the denominator for safety variable. Therefore, 447 out of 450 subjects have been considered for denominator calculation. | Posted | Number | 95% Confidence Interval | % of subjects after PICC placement | from insertion though removal or 180 days, whichever comes first |
|
| ||||||||||||||||||||||||||
| Secondary | Secondary Safety: Incidence of Catheter-related Bloodstream Infection. | Incidence of Catheter-related bloodstream infection where Catheter-related bloodstream infection is defined as positive blood culture(s) with a microorganism not related to another source (e.g., UTI) OR positive blood culture(s) with microorganism matching catheter tip culture OR blood cultures from peripheral venous puncture and PICC positive with the same microorganism. | Since the study device could not be placed in 2 patients and in 1 patient the study device was placed but could not be used for the intended treatment, these 3 subjects were excluded from the denominator for safety variable. Therefore, 447 out of 450 subjects have been considered for denominator calculation. | Posted | Number | 95% Confidence Interval | % of subjects after PICC placement | from insertion though removal or 180 days, whichever comes first |
|
| ||||||||||||||||||||||||||
| Secondary | Secondary Safety: Incidence of Accidental Dislodgement. | Incidence of Accidental dislodgement where Accidental dislodgement is defined as catheter accidentally dislodged the extent to which it requires replacement. | Since the study device could not be placed in 2 patients and in 1 patient the study device was placed but could not be used for the intended treatment, these 3 subjects were excluded from the denominator for safety variable. Therefore, 447 out of 450 subjects have been considered for denominator calculation. | Posted | Number | 95% Confidence Interval | % of subjects after PICC placement | from insertion though removal or 180 days, whichever comes first |
|
| ||||||||||||||||||||||||||
| Secondary | Secondary Safety: Incidence of Vessel Laceration. | Incidence of vessel laceration where vessel laceration is defined as a tear in the tissue of the vessel. | Posted | Number | 95% Confidence Interval | % of subjects after PICC placement | from insertion though removal or 180 days, whichever comes first |
|
| |||||||||||||||||||||||||||
| Secondary | Secondary Safety: Incidence of Vessel Perforation. | Incidence of vessel perforation where vessel perforation is defined as a hole formed in the vessel. | Posted | Number | 95% Confidence Interval | % of subjects after PICC placement | from insertion though removal or 180 days, whichever comes first |
|
| |||||||||||||||||||||||||||
| Secondary | Secondary Performance: Percent of Patent Catheters | Percent of patent catheters defined as the number of functional catheters through therapy/total number of catheters. | A total of 447 subjects received treatment via the study device and were included in the evaluable set, used for the performance calculation. However, 2 subjects were lost to follow-up and were not included in the calculation of percentage. Patent catheters are defined as functional catheters through therapy. | Posted | Number | 95% Confidence Interval | % of subjects after PICC placement | from insertion though removal or 180 days, whichever comes first |
|
| ||||||||||||||||||||||||||
| Secondary | Secondary Performance: Percent of Placement Success in Single Insertion Attempt | Percent of placement success in single insertion attempt defined as placement success defined as single insertion attempt, proper tip location, and patent catheter | Posted | Number | 95% Confidence Interval | % of subjects after PICC placement | during the insertion procedure |
|
| |||||||||||||||||||||||||||
| Secondary | Secondary Performance - Usability: Ease of Insertion | Ease of insertion determined by composite score of guidewire/stylet performance based on post-insertion survey (5 point Likert scale) | The analysis is based on the investigators who completed the questionnaire and answer the respective question. | Posted | Count of Participants | Participants | during the insertion procedure |
|
| |||||||||||||||||||||||||||
| Other Pre-specified | Usability: Ease of Insertion When the Sherlock 3CG Pre-Loaded Stylet Used | The percentage of Sherlock 3CG Pre-Loaded Stylet that aided in guidance and placement of the catheter, when used | The analysis is based on the investigators who completed the questionnaire and answer the respective question. | Posted | Count of Participants | Participants | during the insertion procedure |
|
| |||||||||||||||||||||||||||
| Post-Hoc | Post-hoc Analysis: Device Lifetime | Post-hoc analysis: overall mean device lifetime | The overall mean device lifetime | Posted | Mean | Standard Deviation | days | from insertion though removal or 180 days, whichever comes first |
|
|
From PICC insertion though removal or 180 days, whichever comes first
An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device.
An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Subjects | Patients who received a device from the BD PowerPICC family according to the clinical practice. | 32 | 450 | 58 | 450 | 162 | 450 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Ileal stenosis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Catheter bacteraemia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Subdiaphragmatic abscess | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Gouty arthritis | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Cervix carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Germ cell cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Hepatic cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Metastases to peritoneum | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Neurofibrosarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Pancreatic carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Rectal cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Renal cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Thyroid cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Tongue cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Device breakage | Product Issues | MedDRA 23.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Ileal stenosis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Catheter site discharge | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Catheter site dryness | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Catheter site erythema | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Catheter site exfoliation | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Catheter site granuloma | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Catheter site haematoma | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Catheter site haemorrhage | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Catheter site hypersensitivity | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Catheter site irritation | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Catheter site necrosis | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Catheter site edema | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Catheter site pruritus | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Catheter site related reaction | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Catheter site thrombosis | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Catheter site vesicles | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Complication of device remova | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Device related thrombosis | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Sensation of foreign body | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vessel puncture site injury | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Catheter bacteraemia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Enterococcal bacteraemia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Subdiaphragmatic abscess | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Skin injury | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Gouty arthritis | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vertebral foraminal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Cervix carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Germ cell cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Hepatic cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Metastases to peritoneum | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Neurofibrosarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Pancreatic carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Rectal cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Renal cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Thyroid cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Tongue cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Device breakage | Product Issues | MedDRA 23.0 | Systematic Assessment |
| |
| Device dislocation | Product Issues | MedDRA 23.0 | Systematic Assessment |
| |
| Device occlusion | Product Issues | MedDRA 23.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Oesophageal operation | Surgical and medical procedures | MedDRA 23.0 | Systematic Assessment |
| |
| Venous perforation | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
PI submits to Sponsor for review a draft 90 days prior to submission of the draft for publication.Draft shall not divulge any confidential info.Sponsor has the right to:review and make comments on any proposed publication; withhold the use of its name in connection with publication;make any results from the study known to its customers and governmental agencies prior to publication.The first publication of the study results shall be made in conjunction with the results from the other PIs.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Manager | Becton, Dickinson and Company | 00393452237718 | gloria.viti@bd.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 28, 2022 | Jul 24, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D002406 | Catheterization, Peripheral |
| ID | Term |
|---|---|
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Belgium |
|
| Czechia |
|
| Denmark |
|
| Italy |
|
| Switzerland |
|
| Germany |
|
| Spain |
|
| Past and/or current atrial fibrillation or other atrial arrhythmias that affects the p-wave |
|
| Known absence of a p-wave |
|
| Abnormalities of the arms |
|
| Abnormalities of the chest wall |
|
| History of coagulopathy |
|
| History of hypercoagulopathy |
|
| Current treatment with anticoagulants |
|
| Central venous access devices |
|
| History of LN dissection/ lymphedema |
|
| Renal impairment |
|
| History of phlebitis |
|
| History of venous thrombosis |
|
| History of deep vein thrombosis |
|
| History of catheter related bloodstream inf. |
|
| Other relevant medical history |
|
| Neurological |
|
| Infection |
|
| Surgical |
|
| Oncological |
|
| Vascular |
|
| Gastrointestinal |
|
| Other |
|
| Intravenous therapy: immunoglobulins |
|
| Intravenous therapy:antimicrobial/antifungal |
|
| Intravenous therapy:blood product and transfusion |
|
| Intravenous therapy: chemotherapy |
|
| Intravenous therapy:pain management |
|
| Intravenous therapy: total parenteral nutrition |
|
| Intravenous therapy: vasopressors |
|
| Limited peripheral access |
|
| Nutritional support |
|
| Other includes post covid pancreatytis therapy and hypertension IV pharmacotherapy |
|
| Serial blood sampling |
|
| Serial radiographic studies |
|
| Thrombocytopenia or coagulopathy |
|
| Other |
|
| Missing information - no study device placed |
|
| Brachial |
|
| Other |
|
| Number of insertion attempts=3 |
|
| Number of insertion attempts=4 |
|
| Number of insertion attempts=5 |
|
| Other |
|
| Missing information - no study device placed |
|
| Other |
|
| Missing information - no study device placed |
|
|
|
|
|
|
|
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| Title | Denominators | Categories | ||||
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| Title | Denominators | Categories |
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