Powered Handle Primary Sleeve Gastrectomy Study

NCT06474637 | Recruiting FDA Device

• 1 other identifier: Endostapler05
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleeve Gastrectomy

Keywords

LSG (Laparoscopic Sleeve Gastrectomy)

Outcome Measures

Primary Outcomes (1)

• Post Operative Staple Line Complications

  The primary measure of effectiveness and safety will be determined by the incidence of post-operative staple line complications defined as requiring blood transfusion and revision surgery to treat staple line complications.

  1 week

Secondary Outcomes (2)

• Hospital Stay

  1 week

• 36-Item Short Form Health Survey (SF-36)

  3 weeks

Study Arms (1)

Single Arm

EXPERIMENTAL

Device: AEON Endoscopic Powered Stapler Handle and Reload

Interventions

AEON Endoscopic Powered Stapler Handle and Reload DEVICE

The AEON™ Endoscopic Stapler places two triple-staggered rows of titanium staples while simultaneously transecting between the two triple-staggered rows of staples. The size of the staples and staple line length are based on the selection of the Stapler Reload (2.0mm, 2.5mm, 3.25mm, 4.0mm, 5.0mm and 5.5mm).

Single Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Known sensitivity to implant materials
• Evidence of active (systemic or localized) infection at time of surgery
• Women who are pregnant or planning to get pregnant in the next 12 months
• Recent history of known alcohol and/or narcotic abuse
• Investigational drug or device use within 30 days
• Any other factors that may contribute, based on professional judgement of the treating surgeon, to the subject being a poor candidate for the study

Sponsors & Collaborators

• Lexington Medical Inc.: lead

Study Sites (1)

Gijos Clinic

Kaunas, Lithuania

RECRUITING

Central Study Contacts

Antanas Mickevicius

CONTACT

+37069879074; a_mickevicius@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: June 25, 2024
• Study Start: January 30, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: January 14, 2026

Record last verified: 2026-01

Locations

LI (1)