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

NCT ID: NCT04763421

Last Updated: 2024-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 145 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-22
• Study Completion Date: 2023-09-29

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 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.

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.

Conditions

Upper GI; Lower GI; Gynecological

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Upper Gastrointestinal/Lower Gastrointestinal/Gynecological

Any upper gastrointestinal/lower gastrointestinal/gynecological procedure where the ENSEAL X1 Curved Jaw is used for vessel transection according to instructions for use.

Group Type: EXPERIMENTAL

ENSEAL X1 Curved Jaw

Intervention Type: DEVICE

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

Interventions

ENSEAL X1 Curved Jaw

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. 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;

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

3. At least 18 years of age.

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 study endpoints.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ethicon Endo-Surgery

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ahmar Shah, MD

Role: PRINCIPAL_INVESTIGATOR

Yeovil District Hospital

Anna Fagotti, MD

Role: PRINCIPAL_INVESTIGATOR

Gemelli Hospital

Sergio Alfieri, MD

Role: PRINCIPAL_INVESTIGATOR

Gemelli Hospital

Richard Skipworth, MD

Role: PRINCIPAL_INVESTIGATOR

Royal Infirmary of Edinburgh

Hugh Paterson, MD

Role: PRINCIPAL_INVESTIGATOR

Western General Hospital

Keith Gersin, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

James Hopkins, MD

Role: PRINCIPAL_INVESTIGATOR

Southmead Hospital

Locations

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

Countries

United States; Italy; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ENG_2019_01

Identifier Type: -

Identifier Source: org_study_id