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

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

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).

Study Overview

• Status: Completed
• Conditions: Thoracic Procedure; Urologic Procedure; Ear, Nose and Throat Procedure
• Intervention / Treatment: Device: ENSEAL X1 Curved Jaw Tissue Sealer

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Chiba, Japan
    • National Cancer Center Hospital East
  • Kanagawa, Japan
    • Kitasato University
  • Yokohama, Japan
    • Kanagawa Cancer Center
• Netherlands
  • Sittard, Netherlands
    • Zuyderland Medical Center
• United Kingdom
  • Edinburgh, United Kingdom
    • Western General Hospital
• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Methodist Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Thoracic, Urologic, Ear, Nose and Throat (ENT) Procedures; 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; ENSEAL X1 curved jaw tissue sealer is used for transecting and sealing vessels during thoracic, urologic, or ENT procedures according to instructions for use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adhesion Removal or Division Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score	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.	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	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 lymphatics bundles division by ENSEAL X1.	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	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 tissue bundles division by ENSEAL X1.	On the day of transection (Day 0)
Number of Participants With Tissue Grasping Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score	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 tissue grasping by ENSEAL X1.	On the day of transection (Day 0)
Number of Participants With Tissue Cutting Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score	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 tissue cutting by ENSEAL X1.	On the day of transection (Day 0)
Number of Participants With Tissue Dissection Using ENSEAL X1 Device as Assessed by Surgeon Satisfaction Scale Score	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 tissue dissection by ENSEAL X1.	On the day of transection (Day 0)
Number of Vessels With Hemostasis (Grade 1 to 4) Based on 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 1 to 4 hemostasis was reported.	On the day of transection (Day 0)
Percentage of Grade 4 Vessel Transections Requiring Hemostasis Measures Such as Sutures and Hemoclips	Percentage of grade 4 vessel transections requiring hemostasis measures such as sutures and hemoclips were reported.	On the day of transection (Day 0)

Collaborators and Investigators

• Sponsor: Ethicon Endo-Surgery
• Investigators: Study Director: Ethicon Endo-Surgery Clinical Trial, Ethicon Endo-Surgery

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2021
• Primary Completion (Actual): October 21, 2022
• Study Completion (Actual): November 30, 2022

Study Registration Dates

• First Submitted: September 24, 2021
• First Submitted That Met QC Criteria: September 24, 2021
• First Posted (Actual): October 5, 2021

Study Record Updates

• Last Update Posted (Estimated): December 21, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aortic Diseases; Dissection, Blood Vessel; Acute Aortic Syndrome; Aortic Dissection
• Other Study ID Numbers: ENG_2020_04 (Other Identifier: Ethicon Endo-Surgery)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes