Bariatric SurgerySLEEVENCT03900481
Use of an Endoluminal-suturing Device for Endoscopic Gastric Reduction as an Aid for Class I Obesity, or Class II Obesity Without Comorbidity
A study testing Vertical gastric plication in people with Bariatric Surgery and Morbid Obesity, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
The primary objective is to measure the impact of this treatment for patients with obesity of class I, or class II without co-morbidity, assessed by excess weight loss (EWL)>25%. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bariatric Surgery, Morbid Obesity
- What is being tested?
- Vertical gastric plication
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteFrance
- Study dates
- 17 Sep 2019to 16 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 18 years ≤ age ≤ 65 years
- Class I obesity (30 <BMI <35 kg / m²) or Class II without comorbidity (35 <BMI <40 kg / m²)
Who cannot join
- Achalasia or other disturbance of motility of the esophagus;
- severe esophagitis;
- Peptic ulcer disease;* uncontrolled diabetes
- Weight loss> 5% of the total weight over the last 6 months;
- Gastrointestinal stenosis or obstruction;
- Pregnancy, breastfeeding, or desire for pregnancy in the next 18 months;
- Previous bariatric surgery, balloon or other endoscopic therapy of obesity;
- Gastric surgery scheduled within 60 days of surgery
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective is to measure the impact of this treatment for patients with obesity of class I, or class II without co-morbidity, assessed by excess weight loss (EWL)>25%. The secondary objectives are to measure total body weight loss >5%, BMI reduction, tolerance, complications related to this technique in this indication. This study is a prospective, pilot, bi-center safety and efficacy study. 30 patients will be enrolled between APHM, Marseille et CHU L'Archet Nice
Read the detailed description
Surgery is currently the only effective treatment for morbid obesity and can be divided into restrictive surgeries (Sleeve gastrectomy), or malabsorptive surgery (Bypass surgery). The good medical practice guidelines recommend bariatric surgery for patients with body mass index (BMI) greater than 40 kg/m² without co-morbidities or between 35 and 40 kg/m² with co-morbidities (cardiovascular diseases, diabetes, sleep apnea, etc). Bariatric surgery is currently not an option for obese patients with a BMI between 30 and 35 kg/m² with or without comorbidities (Class I) or with a BMI between 35 and 40 kg/m² without comorbidity (Class II without comorbidity). Patients with obesity of class I, or class II without co-morbidity, currently have no possibility of interventional treatment other than nutritional therapy.
Vertical gastric plication ( without cutting gastric wall) is a novel surgical approach for reducing the stomach capacity. A transoral or endoluminal approach (i.e. a procedure that requires no incision, because access is granted through the mouth) offers some potential additional benefit to the patient, because the procedures continue to become more and more minimally invasive. Advances in endoluminal devices are now allowing clinicians the ability to begin exploring bariatric procedures performed via flexible endoscopy. Although these procedures may not be as effective as their surgical counterparts, these less-invasive options may relieve patients of the significant risks associated with surgery and might become part of the armamentarium of obesity management (5). Endomina (Endo Tools Therapeutics, Gosselies, Belgium) is a CE marked device that offers the possibilities of making transoral full thickness tissue apposition and may allow performing, via a transoral route, large plications with tight serosa to serosa apposition.
The investigators wish to carry out a bi-centric pilot study (Marseille, Nice) which will validate the effectiveness (in terms of excess weight loss and total body weight loss) of this new endoscopic technique for patients previously excluded from any surgical management of their obesity (class I, or class II without comorbidity). The primary objective is to measure the impact of this treatment for patients with obesity of class I, or class II without co-morbidity, assessed by excess weight loss (EWL)>25%. The secondary objectives are to measure total body weight loss >5%, BMI reduction, tolerance, complications related to this technique in this indication. This study is a prospective, pilot, bi-center safety and efficacy study. 30 patients will be enrolled between APHM, Marseille et CHU L'Archet Nice
- Conditions
- Bariatric Surgery, Morbid Obesity
- Being tested
- Vertical gastric plication
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vertical gastric plicationProcedure or surgery
Vertical gastric plication ( without cutting gastric wall) is a novel surgical approach for reducing the stomach capacity. A transoral or endoluminal approach (i.e. a procedure that requires no incision, because access is granted through the mouth) offers some potential additional benefit to the patient, because the procedures continue to become more and more minimally invasive.
| Study group | Role | What they receive |
|---|---|---|
| Vertical gastric plication | Experimental | Vertical gastric plication ( without cutting gastric wall) is a novel surgical approach for reducing the stomach capacity. A transoral or endoluminal approach (i.e. a procedure that requires no incision, because access is granted through the mouth) offers some potential additional benefit to the patient, because the procedures continue to become more and more minimally invasive Receives: Procedure: Vertical gastric plication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the excess weight loss
Measure the impact of this treatment for patients with obesity of class I, or class II without co-morbidity, assessed by excess weight loss (EWL)>25%
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start17 Sep 2019
- Primary completion16 May 2023
- Study completion16 May 2024
Why it stopped: Premature end of inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilie Garrido-Pradalie, Study director, Assistance Publique- Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03900481
- Sponsor's protocol ID
- 2019-18
- Other IDs
- 2019-A00261-56
- Acronym
- SLEEVE
- Status last verified
- Apr 2025
- First submitted
- 1 Apr 2019
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of an Endoluminal-suturing Device for Endoscopic Gastric Reduction as an Aid for Class I Obesity, or Class II Obesity Without Comorbidity
- ClinicalTrials.gov ID
- NCT03900481
- Acronym / sponsor ID
- SLEEVE / 2019-18
- Conditions
- Bariatric Surgery, Morbid Obesity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Premature end of inclusion
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 17 Sep 2019 (actual)
- Primary completion
- 16 May 2023 (actual)
- Study completion
- 16 May 2024 (actual)
- First posted
- 3 Apr 2019 (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 primary objective is to measure the impact of this treatment for patients with obesity of class I, or class II without co-morbidity, assessed by excess weight loss (EWL)>25%. The secondary objectives are to measure total body weight loss >5%, BMI reduction, tolerance, complications related to this technique in this indication. This study is a prospective, pilot, bi-center safety and efficacy study. 30 patients will be enrolled between APHM, Marseille et CHU L'Archet Nice
Detailed description
Surgery is currently the only effective treatment for morbid obesity and can be divided into restrictive surgeries (Sleeve gastrectomy), or malabsorptive surgery (Bypass surgery). The good medical practice guidelines recommend bariatric surgery for patients with body mass index (BMI) greater than 40 kg/m² without co-morbidities or between 35 and 40 kg/m² with co-morbidities (cardiovascular diseases, diabetes, sleep apnea, etc). Bariatric surgery is currently not an option for obese patients with a BMI between 30 and 35 kg/m² with or without comorbidities (Class I) or with a BMI between 35 and 40 kg/m² without comorbidity (Class II without comorbidity). Patients with obesity of class I, or class II without co-morbidity, currently have no possibility of interventional treatment other than nutritional therapy.
Vertical gastric plication ( without cutting gastric wall) is a novel surgical approach for reducing the stomach capacity. A transoral or endoluminal approach (i.e. a procedure that requires no incision, because access is granted through the mouth) offers some potential additional benefit to the patient, because the procedures continue to become more and more minimally invasive. Advances in endoluminal devices are now allowing clinicians the ability to begin exploring bariatric procedures performed via flexible endoscopy. Although these procedures may not be as effective as their surgical counterparts, these less-invasive options may relieve patients of the significant risks associated with surgery and might become part of the armamentarium of obesity management (5). Endomina (Endo Tools Therapeutics, Gosselies, Belgium) is a CE marked device that offers the possibilities of making transoral full thickness tissue apposition and may allow performing, via a transoral route, large plications with tight serosa to serosa apposition.
The investigators wish to carry out a bi-centric pilot study (Marseille, Nice) which will validate the effectiveness (in terms of excess weight loss and total body weight loss) of this new endoscopic technique for patients previously excluded from any surgical management of their obesity (class I, or class II without comorbidity). The primary objective is to measure the impact of this treatment for patients with obesity of class I, or class II without co-morbidity, assessed by excess weight loss (EWL)>25%. The secondary objectives are to measure total body weight loss >5%, BMI reduction, tolerance, complications related to this technique in this indication. This study is a prospective, pilot, bi-center safety and efficacy study. 30 patients will be enrolled between APHM, Marseille et CHU L'Archet Nice
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vertical gastric plication | Experimental | Procedure: Vertical gastric plicationVertical gastric plication ( without cutting gastric wall) is a novel surgical approach for reducing the stomach capacity. A transoral or endoluminal approach (i.e. a procedure that requires no incision, because access is granted through the mouth) offers some potential additional benefit to the patient, because the procedures continue to become more and more minimally invasive |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years ≤ age ≤ 65 years
- Class I obesity (30 <BMI <35 kg / m²) or Class II without comorbidity (35 <BMI <40 kg / m²)
Key exclusion criteria (8 listed)
- Achalasia or other disturbance of motility of the esophagus;
- severe esophagitis;
- Peptic ulcer disease;* uncontrolled diabetes
- Weight loss> 5% of the total weight over the last 6 months;
- Gastrointestinal stenosis or obstruction;
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 |
|---|---|---|
| Vertical gastric plicationVertical gastric plication ( without cutting gastric wall) is a novel surgical approach for reducing the stomach capacity. A transoral or endoluminal approach (i.e. a procedure that requires no incision, because access is granted through the mouth) offers some potential additional benefit to the patient, because the procedures continue to become more and more minimally invasive. | Procedure or surgery | Vertical gastric plication |
Primary outcome
Assessment of the excess weight loss
Time frame: 12 months
Measure the impact of this treatment for patients with obesity of class I, or class II without co-morbidity, assessed by excess weight loss (EWL)>25%
Results and safety
The study was stopped early (reason given: Premature end of inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
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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. This study is not recruiting at the moment.
Emilie Garrido-Pradalie study director
Assistance Publique- Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vertical gastric plication in people with Bariatric Surgery and Morbid Obesity, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 2 inclusion and 8 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: stopped early, as of the sponsor's last update on 3 Apr 2025. 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 France. 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?
The study was stopped early (reason given: Premature end of inclusion). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the excess weight loss (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Apr 2025.