Trials / Completed
CompletedNCT03441178
A Prospective, Multi-Center Evaluation of the ENSEAL X1 Large Jaw Tissue Sealer
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 101 (actual)
- Sponsor
- Ethicon Endo-Surgery · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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. Investigators will perform each procedure using the device in compliance with their standard surgical approach and the ENSEAL X1 instructions for use.
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 will be no blinding or planned interim analysis in this study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ENSEAL X1 | ENSEAL X1 is used for transecting and sealing vessels according to instructions for use. |
Timeline
- Start date
- 2018-03-13
- Primary completion
- 2019-08-14
- Completion
- 2019-08-30
- First posted
- 2018-02-22
- Last updated
- 2020-09-16
- Results posted
- 2020-09-16
Locations
6 sites across 2 countries: United States, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03441178. Inclusion in this directory is not an endorsement.