Status:
COMPLETED
A Prospective, Multi-Center Evaluation of the ENSEAL X1 Large Jaw Tissue Sealer
Lead Sponsor:
Ethicon Endo-Surgery
Conditions:
Colectomy; Gynecological; Thoracic
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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. Invest...
Detailed Description
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 wi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Physical or psychological condition which would impair study participation; or
- Enrollment in a concurrent clinical study.
Key Trial Info
Start Date :
March 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2019
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT03441178
Start Date
March 13 2018
End Date
August 30 2019
Last Update
September 16 2020
Active Locations (6)
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1
Indiana University
Indianapolis, Indiana, United States, 46202
2
Queen Elizabeth Hospital
Birmingham, United Kingdom, B15 2TH
3
Royal Infirmary of Edinburgh
Edinburgh, United Kingdom, EH16 4SA
4
Western General Hospital
Edinburgh, United Kingdom, EH4 2XU