Powered Handle Primary Sleeve Gastrectomy Study
ConditionSleeve Gastrectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorLexington Medical Inc.
About this trial
The objective of this prospective, single arm, single-center study is to evaluate patients who are undergoing primary sleeve gastrectomy procedures and are surgically treated with the AEON Endoscopic Powered Handle Stapler and Stapler Reload. The primary endpoint is to assess the percentage of patients who encountered post-operative staple line complications (bleeding or leak), defined as requiring blood transfusion or revision surgery due to staple line complications.
Eligibility criteria
Qualifiers
Be within the range of 18-65 years of age
Patients undergoing primary sleeve gastrectomy procedures
Psychosocially, mentally, and physically able to comply with protocol, post-operative management and follow-up schedule.
Disqualifiers
Prior bariatric surgery procedure
Sleeve gastrectomy procedure that is planned to be performed via open approach
Patients receiving anticoagulant medication(s)
Severe heart disease or lung problems
Trial design
Treatments tested in this trial
- AEON Endoscopic Powered Stapler Handle and Reload
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov