Trials / Completed
CompletedNCT04763421
A Prospective, Single-Arm Multi-Center Study of the ENSEAL X1 Curved Jaw Tissue Sealer in Select Procedures
A Prospective, Single-Arm Multi-Center Study of the ENSEAL X1 Curved Jaw Tissue Sealer and Generator G11 in Upper Gastrointestinal, Lower Gastrointestinal, and Gynecological Procedures
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 145 (actual)
- Sponsor
- Ethicon Endo-Surgery · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This prospective, single-arm, multi-center study will collect clinical data in a post-market setting by procedure group (upper gastrointestinal \[GI\], lower GI, and gynecological). Investigators will perform each procedure using the device in compliance with their standard surgical approach and the ENSEAL X1 Curved Jaw and Generator G11 instructions for use.
Detailed description
The primary objective of this study is to demonstrate the acceptable performance and safety of the ENSEAL X1 Curved Jaw and Generator G11 devices when used per the instructions for use.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ENSEAL X1 Curved Jaw | ENSEAL X1 Curved Jaw is used for vessel transection according to instructions for use. |
Timeline
- Start date
- 2021-04-22
- Primary completion
- 2023-08-30
- Completion
- 2023-09-29
- First posted
- 2021-02-21
- Last updated
- 2024-09-24
- Results posted
- 2024-09-24
Locations
6 sites across 3 countries: United States, Italy, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04763421. Inclusion in this directory is not an endorsement.