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The objective of this study is to evaluate the safety and effectiveness of Covidien's Hemostatic Patch to control bleeding during hepatic surgery. The performance of the Hemostatic Patch will be compared to Control as an adjunct to conventional hemostatic techniques.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Veriset Hemostatic Patch | Experimental | Veriset Hemostatic Patch |
|
| Fibrin Sealant (TachoSil®) | Active Comparator | Fibrin Sealant (TachoSil®) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Veriset Hemostatic Patch | Device | Topical hemostat |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Median Time to Achieve Hemostasis Following Application of Study Treatment. | Stopwatches will be provided to document time to hemostasis. Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved. | Intra-operative (day 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects to Achieve Hemostasis Within 3 Minutes of Study Treatment Application | Stopwatches will be provided to document time to hemostasis. Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved. | Intra-operative (day 1) |
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Major Inclusion Criteria:
Major Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amy Pollack, MD | Medtronic - MITG | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Innsbruck | Austria | |||||
Subjects who met the pre-operative eligibility criteria were considered for study participation. During the surgical procedures, subjects who met the intra-operative eligibility criteria were randomized. Subjects who did not meet all criteria were considered screen failures and not randomized.
Subjects who were scheduled for non-emergent, open hepatic surgery were assessed for potential study eligibility via a screening/baseline assessment performed within 30 days of their scheduled procedure.
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| ID | Title | Description |
|---|---|---|
| FG000 | Veriset Hemostatic Patch | Subject received the topical hemostat Veriset Hemostatic Patch |
| FG001 | Fibrin Sealant (TachoSil®) | Subject received the topical hemostat TachoSil® |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Veriset Hemostatic Patch | Subject received the topical hemostat Veriset Hemostatic Patch |
| BG001 | Fibrin Sealant (TachoSil®) | Subject received the topical hemostat TachoSil® |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Median Time to Achieve Hemostasis Following Application of Study Treatment. | Stopwatches will be provided to document time to hemostasis. Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved. | Per the study protocol, the ITT population will serve as the primary analysis population for effectiveness. One randomized subject, Subject 1104, did not receive the assigned treatment (TachoSil®). | Posted | Median | Full Range | Minutes | Intra-operative (day 1) |
|
Adverse events were collected from the time of randomization through the 30 day follow-up visit.
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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 | Veriset Hemostatic Patch | Subject received the topical hemostat Veriset Hemostatic Patch |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ascites | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | MedDRA (12.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Medical Affairs | Covidien | 203-500-4256 | amy.pollack@covidien.com |
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| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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| Fibrin Sealant (TachoSil®) |
| Device |
Topical hemostat |
|
| Number of Subjects With Treatment-emergent Adverse Events | Up to 30 days post surgery. |
| Ghent |
| Belgium |
| Leuven | Belgium |
| Hanover | Germany |
| Heidelberg | Germany |
| München | Germany |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Subject received the topical hemostat TachoSil®. |
|
|
|
| Secondary | Number of Subjects to Achieve Hemostasis Within 3 Minutes of Study Treatment Application | Stopwatches will be provided to document time to hemostasis. Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved. | Per the study protocol, the ITT population will serve as the primary analysis population for effectiveness and will be discussed in this report. One randomized subject, Subject 1104, did not receive the assigned treatment (TachoSil). | Posted | Number | Participants | Intra-operative (day 1) |
|
|
|
|
| Secondary | Number of Subjects With Treatment-emergent Adverse Events | All treated subjects are included in the Safety population. | Posted | Number | Participants | Up to 30 days post surgery. |
|
|
|
|
| 10 |
| 32 |
| 22 |
| 32 |
| EG001 | Fibrin Sealant (TachoSil®) | Subject received the topical hemostat TachoSil®. | 8 | 17 | 10 | 17 |
| Multi-organ failure | General disorders | MedDRA (12.1) | Non-systematic Assessment |
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| Biloma | Hepatobiliary disorders | MedDRA (12.1) | Non-systematic Assessment |
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| Abdominal abscess | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
|
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
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| Device related sepsis | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
|
| Escherichia infection | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
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| Haematoma infection | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
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| Postoperative wound infection | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
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| Pyothorax | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
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| Post procedural bile leak | Injury, poisoning and procedural complications | MedDRA (12.1) | Non-systematic Assessment |
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| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (12.1) | Non-systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA (12.1) | Non-systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Non-systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA (12.1) | Non-systematic Assessment |
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| Inferior vena caval occlusion | Vascular disorders | MedDRA (12.1) | Non-systematic Assessment |
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| Subclavian vein thrombosis | Vascular disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Abdominal compartment syndrome | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
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| Ascites | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
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| Haemorrhoids | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
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| Localised intraabdominal fluid collection | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
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| Papilla of Vater stenosis | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
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| Inflammation | General disorders | MedDRA (12.1) | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA (12.1) | Non-systematic Assessment |
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| Biloma | Hepatobiliary disorders | MedDRA (12.1) | Non-systematic Assessment |
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| Cholangitis | Hepatobiliary disorders | MedDRA (12.1) | Non-systematic Assessment |
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| Hepatic failure | Hepatobiliary disorders | MedDRA (12.1) | Non-systematic Assessment |
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| Hepatic function abnormal | Hepatobiliary disorders | MedDRA (12.1) | Non-systematic Assessment |
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| Bacterial infection | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
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| Infection | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
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| Postoperative wound infection | Infections and infestations | MedDRA (12.1) | Non-systematic Assessment |
|
| Anaemia postoperative | Injury, poisoning and procedural complications | MedDRA (12.1) | Non-systematic Assessment |
|
| Post procedural bile leak | Injury, poisoning and procedural complications | MedDRA (12.1) | Non-systematic Assessment |
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| Weaning failure | Injury, poisoning and procedural complications | MedDRA (12.1) | Non-systematic Assessment |
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| Wound complication | Injury, poisoning and procedural complications | MedDRA (12.1) | Non-systematic Assessment |
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| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA (12.1) | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA (12.1) | Non-systematic Assessment |
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| Hepatic enzyme increased | Investigations | MedDRA (12.1) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Metastases to chest wall | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Non-systematic Assessment |
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| Metastases to diaphragm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Non-systematic Assessment |
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| Disturbance in attention | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment |
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| Hepatic encephalopathy | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment |
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| Parkinson's disease | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA (12.1) | Non-systematic Assessment |
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| Renal failure actute | Renal and urinary disorders | MedDRA (12.1) | Non-systematic Assessment |
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| Urge incontinence | Renal and urinary disorders | MedDRA (12.1) | Non-systematic Assessment |
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| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Non-systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Non-systematic Assessment |
|
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