A Study of the ENSEAL® X1 Curved Jaw Tissue Sealer and Generator G11 in Thoracic, Urologic, and Ear, Nose, and Throat (ENT) Procedures

NCT05067647 | Completed Results FDA Device

• 1 other identifier: ENG_2020_04
• Study Type: interventional
• Target: 94
• Locations: 4 countries
• Sites: 6

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).

Conditions

Thoracic Procedure; Urologic Procedure; Ear, Nose and Throat Procedure

Outcome Measures

Primary Outcomes (2)

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

  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). Here, the number of vessels that achieved \<=Grade 3 hemostasis was reported.

  On the day of transection (Day 0)

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

  Device-related AEs were those having a relationship of possibly, probably, or causally. 1. Possible-The relationship with use of device was weak but cannot be ruled out completely. Alternative causes were also possible. Cases where relatedness cannot be assessed, or no information had been obtained were also classified as possible. 2. Probable -The relationship with use of device seemed relevant and/or event cannot reasonably be explained by another cause, but additional information may be obtained; 3. Causal relationship-The event was associated with device or with procedures beyond reasonable doubt with event occurred such as, a known side effect; temporal relationship; involves a body-site or organ that device was applied or had an effect on; followed a known response pattern; impact on event when discontinued and reintroduced; Others; Harms due to error in use.

  Baseline up to 6 weeks

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 Tissue Bundles Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score

  On the day of transection (Day 0)

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

  On the day of transection (Day 0)

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

  On the day of transection (Day 0)

Study Arms (1)

Thoracic, Urologic, Ear, Nose and Throat (ENT) Procedures

EXPERIMENTAL

Any thoracic, urologic, or ENT procedure where ENSEAL X1 is used for transecting and sealing vessels according to instructions for use. Participants will be considered enrolled when the ENSEAL X1 device has been attempted to be used for a vessel transection during thoracic, urologic, or ENT procedures.

Device: ENSEAL X1 Curved Jaw Tissue Sealer

Interventions

ENSEAL X1 Curved Jaw Tissue Sealer DEVICE

ENSEAL X1 curved jaw tissue sealer is used for transecting and sealing vessels during thoracic, urologic, or ENT procedures according to instructions for use.

Thoracic, Urologic, Ear, Nose and Throat (ENT) Procedures

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 (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)
• Willingness to give consent and comply with all study-related evaluations and treatment schedule
• At least 18 years of age

You may not qualify if:

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

Sponsors & Collaborators

• Ethicon Endo-Surgery: lead

Study Sites (6)

Methodist Hospital

Omaha, Nebraska, 68114, United States

Location

National Cancer Center Hospital East

Chiba, Japan

Location

Kitasato University

Kanagawa, Japan

Location

Kanagawa Cancer Center

Yokohama, Japan

Location

Zuyderland Medical Center

Sittard, Netherlands

Location

Western General Hospital

Edinburgh, United Kingdom

Location

Related Publications (1)

• Siegel JM, Cummings JF, Clymer JW. Reproducible, repeatable and clinically-relevant hemostasis scoring. J Adv Med Pharm Sci 2014;1:30-39.

  BACKGROUND

Results Point of Contact

• Title: MEDICAL DIRECTOR LCM Compliance
• Organization: Ethicon Endo-Surgery, Inc.

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Ethicon Endo-Surgery Clinical Trial

  Ethicon Endo-Surgery

  STUDY DIRECTOR

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: September 24, 2021
• First Posted: October 5, 2021
• Study Start: November 29, 2021
• Primary Completion: October 21, 2022
• Study Completion: November 30, 2022
• Last Updated: December 21, 2023
• Results First Posted: December 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share

Locations

JP (3); GB (1); NL (1); US (1)