A Prospective, Multi-Center Evaluation of the ENSEAL X1 Large Jaw Tissue Sealer
- Conditions
- Colectomy; Gynecological; Thoracic
- Registration Number
- NCT03441178
- Lead Sponsor
- Ethicon Endo-Surgery
- Brief Summary
This prospective, single-arm, multi-center, evaluation will collect clinical data in a post-market setting. The three types of procedures studied will be colectomy, gynecological, and thoracic. Investigators will perform each procedure using the device in compliance with their standard surgical approach and the ENSEAL X1 instructions for use.
- Detailed Description
The primary objective of this study is to prospectively generate device specific clinical data related to hemostasis in a post-market setting using the ENSEAL X1 per its instructions for use. There will be no blinding or planned interim analysis in this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 101
- Elective procedure (colectomy, gynecological, or thoracic) where at least one vessel is planned to be transected by the ENSEAL X1 device per its instructions for use;
- Willingness to give consent and comply with all study-related evaluations and treatment schedule; and
- At least 18 years of age.
- Physical or psychological condition which would impair study participation; or
- Enrollment in a concurrent clinical study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Percent of Vessels Where Hemostasis (<= Grade 3) is Achieved Using ENSEAL X1 Intraoperative, after vessel has been transected * 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 monopolar device and/or touch-ups with ENSEAL X1;
* Grade 4: significant bleeding (e.g., pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or ligation with additional hemostatic products (e.g., hemoclips, staples, sutures, fibrin sealants, other advanced energy products).
- Secondary Outcome Measures
Name Time Method Number of Hemostasis Grade 4 Transections and Hemostatic Interventions Used Intraoperative, after vessel has been transected * 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 monopolar device and/or touch-ups with ENSEAL X1;
* Grade 4: significant bleeding (e.g., pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or ligation with additional hemostatic products (e.g., hemoclips, staples, sutures, fibrin sealants, other advanced energy products).Hemostasis Grading Assessment for Each Vessel Transection Intraoperative, after vessel has been transected * 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 monopolar device and/or touch-ups with ENSEAL X1;
* Grade 4: significant bleeding (e.g., pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or ligation with additional hemostatic products (e.g., hemoclips, staples, sutures, fibrin sealants, other advanced energy products).Number of Grade 3 Vessels Needing ENSEAL X1 Touch-up Intraoperative, after vessel has been transected * 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 monopolar device and/or touch-ups with ENSEAL X1;
* Grade 4: significant bleeding (e.g., pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or ligation with additional hemostatic products (e.g., hemoclips, staples, sutures, fibrin sealants, other advanced energy products).
Trial Locations
- Locations (6)
Indiana University
🇺🇸Indianapolis, Indiana, United States
Queen Elizabeth Hospital
🇬🇧Birmingham, United Kingdom
Royal Infirmary of Edinburgh
🇬🇧Edinburgh, United Kingdom
Western General Hospital
🇬🇧Edinburgh, United Kingdom
Glasgow Royal Infirmary
🇬🇧Glasgow, United Kingdom
Yeovil District Hospital
🇬🇧Yeovil, United Kingdom
Indiana University🇺🇸Indianapolis, Indiana, United States