Clinical trial NCT05067647: A Study of the ENSEAL® X1 Curved Jaw Tissue Sealer and Generator G11 in Thoracic, Urologic, and Ear, Nose, and Throat (ENT) Procedures
Official title: A Prospective, Single-Arm Multi-Center Study of the ENSEAL® X1 Curved Jaw Tissue Sealer and Generator G11 in Thoracic, Urologic, and Ear, Nose, and Throat (ENT) Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thoracic Procedure
Urologic Procedure
Ear, Nose and Throat Procedure
Lead sponsor: Ethicon Endo-Surgery
Sponsor class: INDUSTRY
First posted: 2021-10-05
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate the acceptable performance and safety of the ENSEAL X1 curved jaw tissue sealer and Ethicon endo-surgery generator G11 (GEN11) devices when used per the instructions for use (IFU).


Eligibility criteria: Inclusion Criteria:

1. Primary laparoscopic or open procedure (thoracic, urologic or ear, nose, and throat \[ENT\]) where at least one vessel is planned to be transected by the ENSEAL X1 curved jaw tissue sealer (ENSEAL X1) device per the Instructions for use (IFU)
2. Willingness to give consent and comply with all study-related evaluations and treatment schedule
3. At least 18 years of age

Exclusion Criteria:

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

Primary outcomes:
measure: Number of Vessels With Less Than or Equal to (<=) Grade 3 Hemostasis Based on Hemostasis Grading Scale
timeFrame: On the day of transection (Day 0)
measure: Number of Participants With at Least One Device-related Adverse Events (AEs)
timeFrame: Baseline up to 6 weeks
Secondary outcomes:
measure: Number of Participants With Adhesion Removal or Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
timeFrame: On the day of transection (Day 0)
measure: Number of Participants With Lymphatics Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
timeFrame: On the day of transection (Day 0)
measure: Number of Participants With Tissue Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
timeFrame: On the day of transection (Day 0)
measure: Number of Participants With Tissue Grasping Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
timeFrame: On the day of transection (Day 0)
measure: Number of Participants With Tissue Cutting Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
timeFrame: On the day of transection (Day 0)
measure: Number of Participants With Tissue Dissection Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score
timeFrame: On the day of transection (Day 0)
measure: Number of Vessels With Hemostasis (Grade 1 to 4) Based on Grading Scale
timeFrame: On the day of transection (Day 0)
measure: Percentage of Grade 4 Vessel Transections Requiring Hemostasis Measures Such as Sutures and Hemoclips
timeFrame: On the day of transection (Day 0)
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Methodist Hospital
state: Nebraska
city: Chiba
country: Japan
facility: National Cancer Center Hospital East
city: Kanagawa
country: Japan
facility: Kitasato University
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center
city: Sittard
country: Netherlands
facility: Zuyderland Medical Center
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
Study officials:
affiliation: Ethicon Endo-Surgery
name: Ethicon Endo-Surgery Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Siegel JM, Cummings JF, Clymer JW. Reproducible, repeatable and clinically-relevant hemostasis scoring. J Adv Med Pharm Sci 2014;1:30-39.