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This prospective, single-arm, multi-center study will collect clinical data in a post-market setting by procedure group (upper gastrointestinal [GI], lower GI, and gynecological). Investigators will perform each procedure using the device in compliance with their standard surgical approach and the ENSEAL X1 Curved Jaw and Generator G11 instructions for use.
The primary objective of this study is to demonstrate the acceptable performance and safety of the ENSEAL X1 Curved Jaw and Generator G11 devices when used per the instructions for use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Upper Gastrointestinal/Lower Gastrointestinal/Gynecological | Experimental | Any upper gastrointestinal/lower gastrointestinal/gynecological procedure where the ENSEAL X1 Curved Jaw is used for vessel transection according to instructions for use. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ENSEAL X1 Curved Jaw | Device | ENSEAL X1 Curved Jaw is used for vessel transection according to instructions for use. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Vessels With Less Than or Equal to (<=) Grade 3 Hemostasis Based on Hemostasis Grading Scale | Number of vessels with <= Grade 3 hemostasis based on hemostasis grading scale were reported. A 4-point grading scale was used to assess hemostasis in blood vessels. Grade 1: no bleeding at transection site; Grade 2: minor bleeding at transection site, no intervention needed; Grade 3: minor bleeding at transection site, mild intervention needed, use of compression, monopolar device and/or touch-ups with ENSEAL X1; or Grade 4: significant bleeding (example, pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or use of additional hemostatic measures (example, hemoclips, staples, sutures, fibrin sealants, other advanced energy products). | On the day of transection (Day 0) |
| Number of Participants With Device-related Adverse Events (AEs) | Number of participants with device-related AEs were reported. Device-related AEs were those AEs identified as having a relationship of possibly, probably, or causally with the study devices. | From Day 0 up to post-procedure follow up visit (up to 28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adhesion Removal or Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Number of participants with adhesion removal or division using ENSEAL X1 device as assessed by Surgeon Satisfaction scale score were reported. Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for adhesion removal or division by ENSEAL X1. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmar Shah, MD | Yeovil District Hospital | Principal Investigator |
| Anna Fagotti, MD | Gemelli Hospital | Principal Investigator |
| Sergio Alfieri, MD | Gemelli Hospital | Principal Investigator |
| Richard Skipworth, MD | Royal Infirmary of Edinburgh | Principal Investigator |
| Hugh Paterson, MD | Western General Hospital | Principal Investigator |
| Keith Gersin, MD | Wake Forest University Health Sciences | Principal Investigator |
| James Hopkins, MD | Southmead Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atrium Health | Charlotte | North Carolina | 28204 | United States | ||
| Gemelli Hospital |
Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
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| ID | Title | Description |
|---|---|---|
| FG000 | ENSEAL X1 Curved Jaw | All participants were treated with ENSEAL X1 curved jaw device for transection of at least one vessel during laparoscopic or open procedure (upper gastrointestinal [GI], lower GI, or gynecological). |
| 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 | Nov 11, 2022 | Aug 28, 2024 |
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| On the day of transection (Day 0) |
| Number of Participants With Lymphatics Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Number of participants with lymphatics bundles division using ENSEAL X1 device as assessed by Surgeon Satisfaction scale score were reported. Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for lymphatic bundles by ENSEAL X1. | On the day of transection (Day 0) |
| Number of Participants With Tissues Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Number of participants with tissues bundles division using ENSEAL X1 device as assessed by Surgeon Satisfaction scale score were reported. Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for tissues bundles by ENSEAL X1. | On the day of transection (Day 0) |
| Number of Participants With Tissues Grasping Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Number of participants with tissues grasping using ENSEAL X1 device as assessed by Surgeon Satisfaction scale score were reported. Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for tissues grasping by ENSEAL X1. | On the day of transection (Day 0) |
| Number of Participants With Tissues Cutting Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Number of participants with tissues cutting using ENSEAL X1 device as assessed by Surgeon Satisfaction scale score were reported. Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for tissues cutting by ENSEAL X1. | On the day of transection (Day 0) |
| Number of Participants With Tissues Dissection Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Number of participants with tissues dissection using ENSEAL X1 device as assessed by Surgeon Satisfaction scale score were reported. Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for tissues dissection by ENSEAL X1. | On the day of transection (Day 0) |
| Number of Vessels With Hemostasis (Grade 1 to 4) Based on Hemostasis Grading Scale | Number of vessels with hemostasis (Grade 1 to 4) based on hemostasis grading scale were reported. A 4-point grading scale was used to assess hemostasis in blood vessels. Grade 1: no bleeding at transection site; Grade 2: minor bleeding at transection site, no intervention needed; Grade 3: minor bleeding at transection site, mild intervention needed, use of compression, monopolar device and/or touch-ups with ENSEAL X1; or Grade 4: significant bleeding (example, pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or use of additional hemostatic measures (example, hemoclips, staples, sutures, fibrin sealants, other advanced energy products). | On the day of transection (Day 0) |
| Percentage of Grade 4 Vessel Transections Requiring Hemostasis Measures | Percentage of Grade 4 vessel transections requiring hemostasis measures were planned to be reported. Data was not collected and analyzed for this outcome measure because there were no hemostatic grade 4 vessel transections. | On the day of transection (Day 0) |
| Rome |
| Italy |
| Southmead Hospital | Bristol | United Kingdom |
| Royal Infirmary of Edinburgh | Edinburgh | United Kingdom |
| Western General Hospital | Edinburgh | United Kingdom |
| Yeovil District Hospital | Yeovil | BA21 4AT | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ENSEAL X1 Curved Jaw | All participants were treated with ENSEAL X1 curved jaw device for transection of at least one vessel during laparoscopic or open procedure (upper gastrointestinal [GI], lower GI, or gynecological). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | 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 | Number of Vessels With Less Than or Equal to (<=) Grade 3 Hemostasis Based on Hemostasis Grading Scale | Number of vessels with <= Grade 3 hemostasis based on hemostasis grading scale were reported. A 4-point grading scale was used to assess hemostasis in blood vessels. Grade 1: no bleeding at transection site; Grade 2: minor bleeding at transection site, no intervention needed; Grade 3: minor bleeding at transection site, mild intervention needed, use of compression, monopolar device and/or touch-ups with ENSEAL X1; or Grade 4: significant bleeding (example, pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or use of additional hemostatic measures (example, hemoclips, staples, sutures, fibrin sealants, other advanced energy products). | Full Analysis Set (FAS) included participants for whom the ENSEAL X1 device was utilized during the surgical procedure. Here, the number of vessels transected analyzed included all vessels that were transected and analyzed for this outcome measure. | Posted | Count of Units | Vessels transected | On the day of transection (Day 0) | Vessels transected | Vessels transected |
|
|
| ||||||||||||||||||||||||||
| Primary | Number of Participants With Device-related Adverse Events (AEs) | Number of participants with device-related AEs were reported. Device-related AEs were those AEs identified as having a relationship of possibly, probably, or causally with the study devices. | The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure. | Posted | Count of Participants | Participants | From Day 0 up to post-procedure follow up visit (up to 28 days) |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adhesion Removal or Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Number of participants with adhesion removal or division using ENSEAL X1 device as assessed by Surgeon Satisfaction scale score were reported. Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for adhesion removal or division by ENSEAL X1. | FAS included participants for whom the ENSEAL X1 device was utilized during the surgical procedure. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | On the day of transection (Day 0) |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Lymphatics Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Number of participants with lymphatics bundles division using ENSEAL X1 device as assessed by Surgeon Satisfaction scale score were reported. Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for lymphatic bundles by ENSEAL X1. | FAS included participants for whom the ENSEAL X1 device was utilized during the surgical procedure. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | On the day of transection (Day 0) |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Tissues Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Number of participants with tissues bundles division using ENSEAL X1 device as assessed by Surgeon Satisfaction scale score were reported. Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for tissues bundles by ENSEAL X1. | FAS included participants for whom the ENSEAL X1 device was utilized during the surgical procedure. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | On the day of transection (Day 0) |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Tissues Grasping Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Number of participants with tissues grasping using ENSEAL X1 device as assessed by Surgeon Satisfaction scale score were reported. Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for tissues grasping by ENSEAL X1. | FAS included participants for whom the ENSEAL X1 device was utilized during the surgical procedure. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | On the day of transection (Day 0) |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Tissues Cutting Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Number of participants with tissues cutting using ENSEAL X1 device as assessed by Surgeon Satisfaction scale score were reported. Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for tissues cutting by ENSEAL X1. | FAS included participants for whom the ENSEAL X1 device was utilized during the surgical procedure. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | On the day of transection (Day 0) |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Tissues Dissection Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score | Number of participants with tissues dissection using ENSEAL X1 device as assessed by Surgeon Satisfaction scale score were reported. Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for tissues dissection by ENSEAL X1. | FAS included participants for whom the ENSEAL X1 device was utilized during the surgical procedure. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | On the day of transection (Day 0) |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Vessels With Hemostasis (Grade 1 to 4) Based on Hemostasis Grading Scale | Number of vessels with hemostasis (Grade 1 to 4) based on hemostasis grading scale were reported. A 4-point grading scale was used to assess hemostasis in blood vessels. Grade 1: no bleeding at transection site; Grade 2: minor bleeding at transection site, no intervention needed; Grade 3: minor bleeding at transection site, mild intervention needed, use of compression, monopolar device and/or touch-ups with ENSEAL X1; or Grade 4: significant bleeding (example, pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or use of additional hemostatic measures (example, hemoclips, staples, sutures, fibrin sealants, other advanced energy products). | FAS included participants for whom the ENSEAL X1 device was utilized during the surgical procedure. Here, the number of vessels transected analyzed included all vessels that were transected and analyzed for this outcome measure. | Posted | Count of Units | vessels transected | On the day of transection (Day 0) | vessels transected | vessels transected |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Grade 4 Vessel Transections Requiring Hemostasis Measures | Percentage of Grade 4 vessel transections requiring hemostasis measures were planned to be reported. Data was not collected and analyzed for this outcome measure because there were no hemostatic grade 4 vessel transections. | FAS included participants for whom the ENSEAL X1 device was utilized during the surgical procedure. | Posted | On the day of transection (Day 0) | percentage of vessels transected | percentage of vessels transected |
|
|
From Day 0 up to post-procedure follow up visit (Up to 28 days)
The Safety Analysis Set (SAS) included all participants who signed informed consent and for whom the ENSEAL X1 device was utilized during the surgical procedure.
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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 | ENSEAL X1 Curved Jaw | All participants were treated with ENSEAL X1 curved jaw device for transection of at least one vessel during laparoscopic or open procedure (upper gastrointestinal [GI], lower GI, or gynecological). | 0 | 145 | 10 | 145 | 58 | 145 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Intra-abdominal haematoma | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Lymphatic fistula | Vascular disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pelvic venous thrombosis | Vascular disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Intra-abdominal haemorrhage | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Genital contusion | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Incision site pain | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Procedural nausea | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Wound complication | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Oxygen saturation decreased | Investigations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Vaginal discharge | Reproductive system and breast disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 23.0 | Non-systematic Assessment |
|
Draft abstracts, manuscripts, and materials for presentation at scientific meetings must be sent to the sponsor at least 60 working days prior to abstract or other relevant submission deadlines. Authorship of publications resulting from this study was based on generally accepted criteria for major medical journals.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director of Clinical Affairs | Ethicon Endo-Surgery | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 25, 2023 | Aug 26, 2024 | SAP_001.pdf |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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| Participants |
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| vessels transected |
|
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| percentage of vessels transected |
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