Status:
COMPLETED
A Prospective, Single-Arm Multi-Center Study of the ENSEAL X1 Curved Jaw Tissue Sealer in Select Procedures
Lead Sponsor:
Ethicon Endo-Surgery
Conditions:
Upper GI; Lower GI; Gynecological
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Detailed Description
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.
Eligibility Criteria
Inclusion
- Primary laparoscopic or open procedure (upper gastrointestinal, lower gastrointestinal, or gynecological) where at least one vessel is planned to be transected by the ENSEAL X1 Curved Jaw device per the instructions for use;
- Willingness to give consent and comply with all study-related evaluations and visit schedule; and
- At least 18 years of age.
Exclusion
- Physical or psychological condition which would impair study participation; or
- Enrollment in a concurrent interventional clinical study that could impact the study endpoints.
Key Trial Info
Start Date :
April 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 29 2023
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT04763421
Start Date
April 22 2021
End Date
September 29 2023
Last Update
September 24 2024
Active Locations (6)
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1
Atrium Health
Charlotte, North Carolina, United States, 28204
2
Gemelli Hospital
Rome, Italy
3
Southmead Hospital
Bristol, United Kingdom
4
Royal Infirmary of Edinburgh
Edinburgh, United Kingdom