A Study Comparing ETHICON™ 4000 Stapler System With Standard of Care Stapling Devices in Adults Undergoing Gastric and Thoracic Procedures

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEthicon Endo-Surgery

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

Treatment groups

300 Participants
are divided into 2 treatment groups

Sponsors and collaborators