A Post Market, Two-Arm, Multi-Center, Randomized Controlled Trial Comparing Clinical Outcomes Using the ETHICON™ 4000 Stapler System Versus Standard of Care Stapling Devices in Adults Undergoing Gastric and Thoracic Procedures
Ethicon Endo-Surgery
Summary
The purpose of this study is to compare how well the ETHICON™ 4000 Stapler works as compared to the standard stapling devices by assessing how often air leaks and bleeding along the staple line occur during lung and stomach surgeries and by evaluating the side effects occurring within 30 days of surgery.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion criteria: * Candidate for a gastric procedure (sleeve gastrectomy) where a surgical stapler is intended to be used on the stomach; or candidate for a thoracic procedure (lung resection; only lobectomy, segmentectomy or wedge) where a surgical stapler is intended to be used on the lung * Willingness to give consent and comply with all study-related evaluations and visit schedule * At least 18 years of age Exclusion criteria: * Physical or psychological condition which would impair study participation * The planned procedure is a revision/ reoperation for the same indication or same…
Interventions
- Device