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

NCT04763421 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2024-09-24

Study results available
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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.

Conditions

  • Upper GI; Lower GI; Gynecological

Interventions

DEVICE

ENSEAL X1 Curved Jaw

ENSEAL X1 Curved Jaw is used for vessel transection according to instructions for use.

Sponsors & Collaborators

  • Ethicon Endo-Surgery

    lead INDUSTRY

Principal Investigators

  • Ahmar Shah, MD · Yeovil District Hospital

  • Anna Fagotti, MD · Gemelli Hospital

  • Sergio Alfieri, MD · Gemelli Hospital

  • Richard Skipworth, MD · Royal Infirmary of Edinburgh

  • Hugh Paterson, MD · Western General Hospital

  • Keith Gersin, MD · Wake Forest University Health Sciences

  • James Hopkins, MD · Southmead Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-22
Primary Completion
2023-08-30
Completion
2023-09-29
FDA Device
Yes

Countries

  • United States
  • Italy
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04763421 on ClinicalTrials.gov