Trials / Completed
CompletedNCT05067647
A Study of the ENSEAL® X1 Curved Jaw Tissue Sealer and Generator G11 in Thoracic, Urologic, and Ear, Nose, and Throat (ENT) Procedures
A Prospective, Single-Arm Multi-Center Study of the ENSEAL® X1 Curved Jaw Tissue Sealer and Generator G11 in Thoracic, Urologic, and Ear, Nose, and Throat (ENT) Procedures
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 94 (actual)
- Sponsor
- Ethicon Endo-Surgery · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to demonstrate the acceptable performance and safety of the ENSEAL X1 curved jaw tissue sealer and Ethicon endo-surgery generator G11 (GEN11) devices when used per the instructions for use (IFU).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ENSEAL X1 Curved Jaw Tissue Sealer | ENSEAL X1 curved jaw tissue sealer is used for transecting and sealing vessels during thoracic, urologic, or ENT procedures according to instructions for use. |
Timeline
- Start date
- 2021-11-29
- Primary completion
- 2022-10-21
- Completion
- 2022-11-30
- First posted
- 2021-10-05
- Last updated
- 2023-12-21
- Results posted
- 2023-12-21
Locations
6 sites across 4 countries: United States, Japan, Netherlands, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05067647. Inclusion in this directory is not an endorsement.