Powered Handle Primary Sleeve Gastrectomy Study
Recruiting
N/A
Interventional Study
Sleeve Gastrectomy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 100 (estimated)
- Sponsor
- Lexington Medical Inc. · Industry
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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 requirin…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Be within the range of 18-65 years of age
2. Patients undergoing primary sleeve gastrectomy procedures
3. Psychosocially, mentally, and physically able to comply with protocol, post-operative management and follow-up schedule.
Exclusion Criteria:
1. Prior bariatric surgery …
Contacts