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New treatment option for Sleeve Gastrectomy
Official title Powered Handle Primary Sleeve Gastrectomy Study
ClinicalTrials.gov ID: NCT06474637
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join 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 likely can't join 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
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Kaunas, Lithuania
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kaunas, Lithuania. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.