N/A N=145 Treatment

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

Upper GI; Lower GI; Gynecological

Bottom Line

View on ClinicalTrials.gov: NCT04763421 ↗

Enrolled (actual)

145

Serious AEs

6.9%

Results posted

Sep 2024

Primary outcome: Primary: Number of Vessels With Less Than or Equal to (<=) Grade 3 Hemostasis Based on Hemostasis Grading Scale — 279 Vessels transected

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: ENSEAL X1 Curved Jaw (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Ethicon Endo-Surgery
Primary completion: Aug 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Vessels With Less Than or Equal to (<=) Grade 3 Hemostasis Based on Hemostasis Grading Scale	279	—
PRIMARY Number of Participants With Device-related Adverse Events (AEs)	2	—
SECONDARY Number of Participants With Adhesion Removal or Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score	0; 0; 1; 27; 21	—
SECONDARY Number of Participants With Lymphatics Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score	0; 0; 1; 18; 8	—
SECONDARY Number of Participants With Tissues Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score	0; 0; 1; 26; 28	—
SECONDARY Number of Participants With Tissues Grasping Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score	0; 4; 9; 31; 23	—
SECONDARY Number of Participants With Tissues Cutting Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score	1; 1; 3; 38; 44	—
SECONDARY Number of Participants With Tissues Dissection Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score	0; 0; 3; 59; 45	—
SECONDARY Number of Vessels With Hemostasis (Grade 1 to 4) Based on Hemostasis Grading Scale	258; 12; 9; 0	—
SECONDARY Percentage of Grade 4 Vessel Transections Requiring Hemostasis Measures	—	—

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.

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

Physical or psychological condition which would impair study participation; or
Enrollment in a concurrent interventional clinical study that could impact the study endpoints.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04763421). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.