Powered Handle Primary Sleeve Gastrectomy Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AEON Endoscopic Powered Stapler Handle and Reload.
- Who it may be relevant to
- Registry conditions: Sleeve Gastrectomy. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Lithuania
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective Clinical Evaluation of the AEON Endoscopic Stapler Powered Handle and Reload in Primary Sleeve Gastrectomy
Overview
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.
Interventions
- Device AEON Endoscopic Powered Stapler Handle and Reload
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).
Primary outcome measures
- Post Operative Staple Line Complications [Time frame: 1 week]
Secondary outcome measures (2)
- Hospital Stay [Time frame: 1 week]
- 36-Item Short Form Health Survey (SF-36) [Time frame: 3 weeks]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Lithuania · 1 center
- Gijos Clinic — Kaunas
Identifiers
NCT: NCT06474637 · Endostapler05