About this trial
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 criteria
Qualifiers
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
Disqualifiers
Physical or psychological condition which would impair study participation
The planned procedure is a revision/ reoperation for the same indication or same anatomical location
Trauma participants
Any condition or clinically significant finding that, in the Investigator's judgement, may interfere with study participation, impact the assessment of endpoints, or compromise the patient's safety or welfare
Trial design
Treatments tested in this trial
- ETHICON™ 4000 Stapler System
- Standard of Care Stapler and Reloads