Trials / Completed
CompletedNCT02338583
Powered Surgical Stapler in VATS Lung Resection Procedures in China
A Prospective, Multi-Center Evaluation of a Powered Surgical Stapler in Video-Assisted Thoracoscopic Lung Resection Procedures in China
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 95 (actual)
- Sponsor
- Ethicon Endo-Surgery · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This prospective, single-arm multi-center study will provide clinical data in an observational setting using the Echelon Flex™ 45 and 60 Powered ENDOPATH® Stapler Articulating Endoscopic Linear Cutters (study Endocutter). Individuals undergoing VATS lobectomy for suspected or confirmed Non Small Cell Lung Cancer (NSCLC), or individuals undergoing VATS diagnostic wedge resection in accordance with their institution's Standard of care (SOC), and who meet study entry criteria, may be enrolled. Study procedures will include a wedge resection, wedge resection followed by lobectomy of the same lobe, or lobectomy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Echelon Flex™ 45 and 60 Powered ENDOPATH® Stapler Articulating Endoscopic Linear Cutter |
Timeline
- Start date
- 2014-12-01
- Primary completion
- 2015-04-01
- Completion
- 2015-05-01
- First posted
- 2015-01-14
- Last updated
- 2017-08-11
Locations
3 sites across 1 country: China
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02338583. Inclusion in this directory is not an endorsement.