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

NCT04763421 | Completed Results FDA Device

• 1 other identifier: ENG_2019_01
• Study Type: interventional
• Target: 145
• Locations: 3 countries
• Sites: 6

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.

Conditions

Upper GI; Lower GI; Gynecological

Outcome Measures

Primary Outcomes (2)

• Number of Vessels With Less Than or Equal to (<=) Grade 3 Hemostasis Based on Hemostasis Grading Scale

  Number of vessels with \<= Grade 3 hemostasis based on hemostasis grading scale were reported. A 4-point grading scale was used to assess hemostasis in blood vessels. 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 touch-ups with ENSEAL X1; or Grade 4: significant bleeding (example, pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or use of additional hemostatic measures (example, hemoclips, staples, sutures, fibrin sealants, other advanced energy products).

  On the day of transection (Day 0)

• Number of Participants With Device-related Adverse Events (AEs)

  Number of participants with device-related AEs were reported. Device-related AEs were those AEs identified as having a relationship of possibly, probably, or causally with the study devices.

  From Day 0 up to post-procedure follow up visit (up to 28 days)

Secondary Outcomes (8)

• Number of Participants With Adhesion Removal or Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score

  On the day of transection (Day 0)

• Number of Participants With Lymphatics Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score

  On the day of transection (Day 0)

• Number of Participants With Tissues Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score

  On the day of transection (Day 0)

• Number of Participants With Tissues Grasping Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score

  On the day of transection (Day 0)

• Number of Participants With Tissues Cutting Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score

  On the day of transection (Day 0)

Study Arms (1)

Upper Gastrointestinal/Lower Gastrointestinal/Gynecological

EXPERIMENTAL

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

Device: ENSEAL X1 Curved Jaw

Interventions

ENSEAL X1 Curved Jaw DEVICE

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

Upper Gastrointestinal/Lower Gastrointestinal/Gynecological

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Ethicon Endo-Surgery: lead

Study Sites (6)

Atrium Health

Charlotte, North Carolina, 28204, United States

Location

Gemelli Hospital

Rome, Italy

Location

Southmead Hospital

Bristol, United Kingdom

Location

Royal Infirmary of Edinburgh

Edinburgh, United Kingdom

Location

Western General Hospital

Edinburgh, United Kingdom

Location

Yeovil District Hospital

Yeovil, BA21 4AT, United Kingdom

Location

Results Point of Contact

• Title: Senior Director of Clinical Affairs
• Organization: Ethicon Endo-Surgery

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Ahmar Shah, MD

  Yeovil District Hospital

  PRINCIPAL INVESTIGATOR

• Anna Fagotti, MD

  Gemelli Hospital

  PRINCIPAL INVESTIGATOR

• Sergio Alfieri, MD

  Gemelli Hospital

  PRINCIPAL INVESTIGATOR

• Richard Skipworth, MD

  Royal Infirmary of Edinburgh

  PRINCIPAL INVESTIGATOR

• Hugh Paterson, MD

  Western General Hospital

  PRINCIPAL INVESTIGATOR

• Keith Gersin, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

• James Hopkins, MD

  Southmead Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: February 21, 2021
• Study Start: April 22, 2021
• Primary Completion: August 30, 2023
• Study Completion: September 29, 2023
• Last Updated: September 24, 2024
• Results First Posted: September 24, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share

Locations

IT (1); US (1); GB (4)