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

  • STATUS
    Recruiting
  • End date
    Sep 30, 2022
  • participants needed
    105
  • sponsor
    Ethicon Endo-Surgery
Updated on 25 May 2022

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).

Details
Condition Thoracic Procedure, Urologic Procedure, Ear, Nose and Throat Procedure
Treatment ENSEAL X1 Curved Jaw Tissue Sealer
Clinical Study IdentifierNCT05067647
SponsorEthicon Endo-Surgery
Last Modified on25 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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

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Step 1 Connect with a study center
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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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