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NCT07744568
A Study Comparing ETHICON™ 4000 Stapler System With Standard of Care Stapling Devices in Adults Undergoing Gastric and Thoracic Procedures
Conditions: Surgical Procedures, Operative
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 300
Sponsor: Ethicon Endo-Surgery
Location: Cedars Sinai Health Sciences University Los Angeles California
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 Criteria
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 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
* Any medical condition that the Investigator deems could impact inflammatory or immune response
* Enrollment in a concurrent interventional clinical study that could impact the study endpoints
Source: ClinicalTrials.gov (NCT07744568). StuddyBuddy aggregates publicly available trial information.