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

Completed · Not applicable

Conditions studied: Thoracic Procedure, Urologic Procedure, Ear, Nose and Throat Procedure

In brief

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).

Key facts

Study ID

NCT05067647

Run by

Ethicon Endo-Surgery

People needed

94

Starts

2021-11-29

Expected to finish

2022-11-30

Last updated by the study team

2023-12-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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