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

Last updated: August 28, 2024
Sponsor: Ethicon Endo-Surgery
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

ENSEAL X1 Curved Jaw

Clinical Study ID

NCT04763421
ENG_2019_01
  • Ages > 18
  • All Genders

Study 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 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Primary laparoscopic or open procedure (upper gastrointestinal, lowergastrointestinal, or gynecological) where at least one vessel is planned to betransected by the ENSEAL X1 Curved Jaw device per the instructions for use;

  2. Willingness to give consent and comply with all study-related evaluations and visitschedule; and

  3. At least 18 years of age.

Exclusion

Exclusion Criteria:

  1. Physical or psychological condition which would impair study participation; or

  2. Enrollment in a concurrent interventional clinical study that could impact the studyendpoints.

Study Design

Total Participants: 145
Treatment Group(s): 1
Primary Treatment: ENSEAL X1 Curved Jaw
Phase:
Study Start date:
April 22, 2021
Estimated Completion Date:
September 29, 2023

Study 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.

Connect with a study center

  • Gemelli Hospital

    Rome,
    Italy

    Site Not Available

  • Southmead Hospital

    Bristol,
    United Kingdom

    Site Not Available

  • Royal Infirmary of Edinburgh

    Edinburgh,
    United Kingdom

    Site Not Available

  • Western General Hospital

    Edinburgh,
    United Kingdom

    Site Not Available

  • Yeovil District Hospital

    Yeovil, BA21 4AT
    United Kingdom

    Site Not Available

  • Atrium Health

    Charlotte, North Carolina 28204
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.