A Prospective, Single-Arm Multi-Center Study of the ENSEAL X1 Curved Jaw Tissue Sealer in Select Procedures

Completed · Not applicable

Conditions studied: Upper GI; Lower GI; Gynecological

In brief

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.

Key facts

Study ID

NCT04763421

Run by

Ethicon Endo-Surgery

People needed

145

Starts

2021-04-22

Expected to finish

2023-09-29

Last updated by the study team

2024-09-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Physical or psychological condition which would impair study participation; or
• Enrollment in a concurrent interventional clinical study that could impact the study endpoints.

Where it is running

• Atrium Health — Charlotte, North Carolina, United States
• Gemelli Hospital — Rome, Italy
• Southmead Hospital — Bristol, United Kingdom
• Royal Infirmary of Edinburgh — Edinburgh, United Kingdom
• Western General Hospital — Edinburgh, United Kingdom
• Yeovil District Hospital — Yeovil, United Kingdom

Full record on ClinicalTrials.gov

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