A Prospective, Multi-Center Evaluation of the ENSEAL X1 Large Jaw Tissue Sealer

Completed · Not applicable

Conditions studied: Colectomy; Gynecological; Thoracic

In brief

This prospective, single-arm, multi-center, evaluation will collect clinical data in a post-market setting. The three types of procedures studied will be colectomy, gynecological, and thoracic. Investigators will perform each procedure using the device in compliance with their standard surgical approach and the ENSEAL X1 instructions for use.

Key facts

Study ID

NCT03441178

Run by

Ethicon Endo-Surgery

People needed

101

Starts

2018-03-13

Expected to finish

2019-08-30

Last updated by the study team

2020-09-16

Who can join

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

You may qualify if…

• Elective procedure (colectomy, gynecological, or thoracic) where at least one vessel is planned to be transected by the ENSEAL X1 device per its instructions for use;
• Willingness to give consent and comply with all study-related evaluations and treatment schedule; and
• At least 18 years of age.

You may not qualify if…

• Physical or psychological condition which would impair study participation; or
• Enrollment in a concurrent clinical study.

Where it is running

• Indiana University — Indianapolis, Indiana, United States
• Queen Elizabeth Hospital — Birmingham, United Kingdom
• Royal Infirmary of Edinburgh — Edinburgh, United Kingdom
• Western General Hospital — Edinburgh, United Kingdom
• Glasgow Royal Infirmary — Glasgow, United Kingdom
• Yeovil District Hospital — Yeovil, United Kingdom

Full record on ClinicalTrials.gov

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