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

Upper GI; Lower GI; Gynecological Clinical Trial

Official title:

A Prospective, Single-Arm Multi-Center Study of the ENSEAL X1 Curved Jaw Tissue Sealer and Generator G11 in Upper Gastrointestinal, Lower Gastrointestinal, and Gynecological Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04763421
• Other study ID #: ENG_2019_01
• Status: Completed
• Phase: N/A
• Start date: April 22, 2021
• Est. completion date: September 29, 2023

Study information

• Verified date: February 2024
• Source: Ethicon Endo-Surgery
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: September 29, 2023
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Upper GI; Lower GI; Gynecological

Intervention

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

Locations

Country	Name	City	State
Italy	Gemelli Hospital	Rome
United Kingdom	Southmead Hospital	Bristol
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh
United Kingdom	Western General Hospital	Edinburgh
United Kingdom	Yeovil District Hospital	Yeovil
United States	Atrium Health	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon Endo-Surgery

Countries where clinical trial is conducted

United States,  Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Achievement of Grade 3 or lower hemostasis for each vessel transection	Grade 1: no bleeding at transection site; Grade 2: minor bleeding at transection site, no intervention needed; Grade 3: minor bleeding at transection site, mild intervention needed, use of compression, monopolar device and/or touchups with ENSEAL X1; or; Grade 4: significant bleeding (e.g., pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or ligation with use of additional hemostatic measures (e.g., hemoclips, staples, sutures, fibrin sealants, other advanced energy products).	Intraoperative
Secondary	Distribution of 5-point scale scores for various tasks completed by the ENSEAL X1 Curved Jaw device (adhesiolysis, lymphatics or tissue bundles divided, tissue grasping, tissue cutting, or tissue dissection)		Intraoperative
Secondary	Distribution of hemostasis grading scale for each vessel transected		Intraoperative
Secondary	Type, name, and number of additional hemostasis products required to achieve hemostasis for Grade 4 vessel transections		Intraoperative