Prospective Clinical Evaluation of the AEON Endoscopic Stapler Powered Handle and Reload in Primary Sleeve Gastrectomy
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Lithuania
Gijos Clinic
RECRUITING
Kaunas
Contact Information
Primary
Antanas Mickevicius
a_mickevicius@yahoo.com
+37069879074
Time Frame
Start Date: 2024-01-30
Estimated Completion Date: 2025-03
Participants
Target number of participants: 50
Treatments
Experimental: Single Arm
Related Therapeutic Areas
Sponsors
Leads: Lexington Medical Inc.