Sleeve GastrectomyNCT06474637
Powered Handle Primary Sleeve Gastrectomy Study
A study testing AEON Endoscopic Powered Stapler Handle and Reload in people with Sleeve Gastrectomy, run by Lexington Medical Inc. at 1 site in Lithuania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sleeve Gastrectomy
- What is being tested?
- AEON Endoscopic Powered Stapler Handle and Reload
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteLithuania
- Study dates
- 30 Jan 2024to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lithuania1 site, 1 recruiting
- Recruiting
Gijos Clinic
Kaunas
Antanas Mickevicius
About this study
Official title: Prospective Clinical Evaluation of the AEON Endoscopic Stapler Powered Handle and Reload in Primary Sleeve Gastrectomy
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
- Being tested
- AEON Endoscopic Powered Stapler Handle and Reload
- Keywords
- LSG (Laparoscopic Sleeve Gastrectomy)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AEON Endoscopic Powered Stapler Handle and ReloadDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Not described Receives: Device: AEON Endoscopic Powered Stapler Handle and Reload |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week
Secondary outcomes (2)
Hospital Stay
Average hospital stay will be measure and compared in patients without post-operative staple line complications vs. patients with post-operative staple line complications.
Measured: 1 week
36-Item Short Form Health Survey (SF-36)
SF-36 scores will be collected at baseline and at the 3-week follow up appointment and compared for quality-of-life changes.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start30 Jan 2024
- Primary completionDec 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleeve GastrectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lexington Medical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06474637
- Sponsor's protocol ID
- Endostapler05
- Status last verified
- Jan 2026
- First submitted
- 20 Jun 2024
- Last updated
- 14 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Mickevicius A, Sikarske A, Kiudelis M. Evaluation of the AEON Powered Stapler System in Primary Sleeve Gastrectomy: Results of a Prospective Clinical Trial. J Metab Bariatr Surg. 2026 Aug;15(2):103-112. doi: 10.17476/jmbs.2026.15.2.103. Epub 2026 Aug 14.
PubMed 42689306
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Evaluation of the AEON Endoscopic Stapler Powered Handle and Reload in Primary Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT06474637
- Acronym / sponsor ID
- Endostapler05
- Conditions
- Sleeve Gastrectomy
- Keywords
- LSG (Laparoscopic Sleeve Gastrectomy)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Lexington Medical Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jan 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 25 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Device: AEON Endoscopic Powered Stapler Handle and Reload |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AEON Endoscopic Powered Stapler Handle and ReloadThe 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). | Device | Single Arm |
Primary outcome
Post Operative Staple Line Complications
Time frame: 1 week
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.
2 secondary outcomes
Hospital Stay
Time frame: 1 week
36-Item Short Form Health Survey (SF-36)
Time frame: 3 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Derived from this study: PubMed 42689306Mickevicius A, Sikarske A, Kiudelis M. Evaluation of the AEON Powered Stapler System in Primary Sleeve Gastrectomy: Results of a Prospective Clinical Trial. J Metab Bariatr Surg. 2026 Aug;15(2):103-112. doi: 10.17476/jmbs.2026.15.2.103. Epub 2026 Aug 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AEON Endoscopic Powered Stapler Handle and Reload in people with Sleeve Gastrectomy, run by Lexington Medical Inc. at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antanas Mickevicius (+37069879074, a_mickevicius@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post Operative Staple Line Complications (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06474637, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.