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



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:1/11/2019
Start Date:March 13, 2018
End Date:August 31, 2019
Contact:Jason R. Waggoner, PhD
Email:jwaggon1@its.jnj.com
Phone:513-337-8130

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Trial Summary
Trial Overview
Inclusion Criteria
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.

The primary objective of this study is to prospectively generate device specific clinical
data related to hemostasis in a post-market setting using the ENSEAL X1 per its instructions
for use. There will be no blinding or planned interim analysis in this study.

Inclusion Criteria:

1. 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;

2. Willingness to give consent and comply with all study-related evaluations and
treatment schedule; and

3. At least 18 years of age.

Exclusion Criteria:

1. Physical or psychological condition which would impair study participation; or

2. Enrollment in a concurrent clinical study.
We found this trial at
2
sites
Indiana University
425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Principal Investigator: Bruce Robb, MD
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Royal Infirmary of Edinburgh
Edinburgh,
Principal Investigator: Mr. Scott Fegan
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