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

NCT ID: NCT05067647

Last Updated: 2023-12-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-29

Study Completion Date

2022-11-30

Brief Summary

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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).

Detailed Description

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Conditions

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Thoracic Procedure Urologic Procedure Ear, Nose and Throat Procedure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

ENSEAL X1 Curved Jaw Tissue Sealer

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ethicon Endo-Surgery

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ethicon Endo-Surgery Clinical Trial

Role: STUDY_DIRECTOR

Ethicon Endo-Surgery

Locations

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Methodist Hospital

Omaha, Nebraska, United States

Site Status

National Cancer Center Hospital East

Chiba, , Japan

Site Status

Kitasato University

Kanagawa, , Japan

Site Status

Kanagawa Cancer Center

Yokohama, , Japan

Site Status

Zuyderland Medical Center

Sittard, , Netherlands

Site Status

Western General Hospital

Edinburgh, , United Kingdom

Site Status

Countries

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United States Japan Netherlands United Kingdom

References

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

Reference Type BACKGROUND

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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ENG_2020_04

Identifier Type: OTHER

Identifier Source: secondary_id

ENG_2020_04

Identifier Type: -

Identifier Source: org_study_id