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

Not Applicable

Completed

• Conditions: Upper GI; Lower GI; Gynecological
• Interventions: Device: ENSEAL X1 Curved Jaw

• Registration Number: NCT04763421
• Lead Sponsor: Ethicon Endo-Surgery

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.

Study Timeline

• Study First Submitted: 2021-02-17
• Study First Submitted QC: 2021-02-17
• Study First Posted: 2021-02-21
• Study Start: 2021-04-22
• Primary Completion: 2023-08-30
• Study Completion: 2023-09-29
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-01
• Last Update Posted: 2024-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 145

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Upper Gastrointestinal/Lower Gastrointestinal/Gynecological	ENSEAL X1 Curved Jaw	Any upper gastrointestinal/lower gastrointestinal/gynecological procedure where the ENSEAL X1 Curved Jaw is used for vessel transection according to instructions for use.

Primary Outcome Measures

Name	Time	Method
Number of Vessels With Less Than or Equal to (<=) Grade 3 Hemostasis Based on Hemostasis Grading Scale	On the day of transection (Day 0)	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).
Number of Participants With Device-related Adverse Events (AEs)	From Day 0 up to post-procedure follow up visit (up to 28 days)	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.

Secondary Outcome Measures

Name	Time	Method
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 adhesion removal or division using ENSEAL X1 device as assessed by Surgeon Satisfaction scale score were reported. Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for adhesion removal or division by ENSEAL X1.
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 lymphatics bundles division using ENSEAL X1 device as assessed by Surgeon Satisfaction scale score were reported. Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for lymphatic bundles by ENSEAL X1.
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 bundles division using ENSEAL X1 device as assessed by Surgeon Satisfaction scale score were reported. Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for tissues bundles by ENSEAL X1.
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 grasping using ENSEAL X1 device as assessed by Surgeon Satisfaction scale score were reported. Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for tissues grasping by ENSEAL X1.
Number of Participants With Tissues Cutting 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 were reported. Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for tissues cutting by ENSEAL X1.
Number of Participants With Tissues Dissection Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score	On the day of transection (Day 0)	Number of participants with tissues dissection using ENSEAL X1 device as assessed by Surgeon Satisfaction scale score were reported. Surgeon satisfaction scale score is a 5-point scale (very dissatisfied, dissatisfied, neither satisfied or dissatisfied, satisfied, or very satisfied) where surgeon rated the use of the device for tissues dissection by ENSEAL X1.
Number of Vessels With Hemostasis (Grade 1 to 4) Based on Hemostasis Grading Scale	On the day of transection (Day 0)	Number of vessels with hemostasis (Grade 1 to 4) 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).
Percentage of Grade 4 Vessel Transections Requiring Hemostasis Measures	On the day of transection (Day 0)	Percentage of Grade 4 vessel transections requiring hemostasis measures were planned to be reported. Data was not collected and analyzed for this outcome measure because there were no hemostatic grade 4 vessel transections.

Trial Locations

Locations (6)

Southmead Hospital; 🇬🇧 Bristol, United Kingdom

Atrium Health; 🇺🇸 Charlotte, North Carolina, United States

Gemelli Hospital; 🇮🇹 Rome, Italy

Royal Infirmary of Edinburgh; 🇬🇧 Edinburgh, United Kingdom

Yeovil District Hospital; 🇬🇧 Yeovil, United Kingdom

Western General Hospital; 🇬🇧 Edinburgh, United Kingdom