ObesityNCT06657339
National Registry of Obesity Treatment by Endosleeve
An observational study of Obesity, run by Société Française d'Endoscopie Digestive.
Trial summary
Obesity and overweight have emerged as public health problems of a pandemic nature, significantly reducing the life expectancy of those affected. Obesity has a considerable medico-economic impact, linked to the treatments it requires and its comorbidities. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Obesity
- What is being tested?
- Therapeutic endoscopy endosleeve using a gastric suturing device (OverStitch™/Endomina™)
- Type of treatment
- Surgery or procedure
- How many people
- 354 participants
- Where
- No sites listed yet
- Study dates
- Dec 2024to Dec 2029
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any referred patient with obesity and a BMI > 30 kg/m² who meets the inclusion criteria and is considered suitable for therapeutic management of obesity will be invited to participate in the study at the investigating centers
Who may be able to join
- Age over 18 years;
- Patient with a body mass index (BMI) ≥ 30 kg/m²;
- Signed informed consent
Who cannot join
- Contraindication to performing an upper endoscopy or using an endoscopic plication system according to the instructions for use (IFU);
- Presence of an ulcer in the gastric body or fundus;
- Achalasia, severe esophagitis (Los Angeles grade C or D);
- ENT or esophageal malformation;
- Gastrointestinal disease (including stenosis), history of previous gastric surgery (including bariatric surgery, previous endoscopic gastroplasty);
- Congestive gastropathy, gastric polyposis, gastric or esophageal varices, risk of gastric tumor disease due to personal or family history;
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- Positive Helicobacter pylori status with failed eradication treatments;
- Uncontrolled or severe eating disorder or psychiatric illness;
- Substance abuse or chronic alcoholism;
- Severe renal insufficiency (stage 4 or 5), Cirrhosis Child B or C;
- Anticoagulant or antiplatelet treatment that cannot be stopped or replaced according to international recommendations (ESGE 2021);
- Coagulation or hemostasis disorders (PT < 60%, platelets < 60,000/mm³);
- Mental deficiency of the subject making participation in the trial impossible;
- Patient not affiliated with a social security scheme;
- Pregnant women, breastfeeding individuals;
- Inability to understand or sign the informed consent.
About this study
Obesity and overweight have emerged as public health problems of a pandemic nature, significantly reducing the life expectancy of those affected. Obesity has a considerable medico-economic impact, linked to the treatments it requires and its comorbidities. Currently, the prevention of obesity in our Western societies is not effective enough, as the prevalence and incidence of obesity and overweight continue to rise worldwide. In France, the therapeutic management of this condition is governed by the HAS and is summarized as a surgical approach for type 2 obesity with comorbidity or type 3 obesity, with three authorized methods that have shown sufficient evidence: gastric banding, sleeve gastrectomy (or longitudinal sleeve gastrectomy), and Roux-en-Y gastric bypass.
With the advent of organ-preserving interventional endoscopy, the systematic use of these surgical methods, although effective for total weight loss and excess weight loss, raises questions. Indeed, these new therapeutic endoscopic approaches, which are less invasive, less costly, and respectful of anatomy, currently show convincing cohort results in the short term (12 to 24 months) and require confirmation of their effectiveness and safety in the long term (5 years) so that they can become first-line therapeutic methods in the near future. At the request of the HAS in its self-referral of 2020 and then in 2022, this prospective registry aims to confirm the effectiveness and safety of the endosleeve (or endoscopic sleeve) in the long-term therapeutic management of obesity within the framework of everyday practice in national reference centers for obesity treatment.
- Conditions
- Obesity
- Being tested
- Therapeutic endoscopy endosleeve using a gastric suturing device (OverStitch™/Endomina™)
- Keywords
- Endosleeve, Endoscopic gastroplasty, Endoscopic suture
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic endoscopy endosleeve using a gastric suturing device (OverStitch™/Endomina™)Procedure or surgery
The patient will undergo therapeutic endoscopy under general anesthesia, either as outpatient or inpatient care, based on the recommendations of the investigating physician, taking into account anesthetic risks and comorbidities. Two CE-marked gastric suturing devices may be used at the discretion of the investigating center based on their practices
OverStich™ allows for tissue fixation via a gastroscope, creating a durable suture through a transabdominal fixation technique. The procedure lasts about 45 minutes and includes measures to prevent vomiting.
Endomina™ is a single-use device that captures the gastric mucosa to create successive plications, allowing for effective suturing along the greater curvature of the stomach.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic sleeve gastroplasty | Therapeutic endoscopy using a gastric suturing device (OverStitch™/Endomina™) according to the practices of the investigating center Receives: Procedure: Therapeutic endoscopy endosleeve using a gastric suturing device (OverStitch™/Endomina™) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of total weight loss (TWL) in % 5 years afther endosleeve
To determine the proportion of patients who met the PIVI criteria after endosleeve without additional techniques
Measured: 5 years
Secondary outcomes (11)
Measurement of total weight loss (TWL) in %
Determine total weight loss (TWL) afther endosleeve at 12, 24 months,
Measured: 12 et 24 months
Measurement excess weight loss after the endosleeve intervention.
Determine excess weight loss (EWL) after the endosleeve intervention, with positivity established by the PIVI criteria (EWL > 25% at 12 months), and evaluate the long-term evolution of this EWL
Measured: 12, 24 months, and 5 years
Measurement of the percentage of postoperative complications according to the AGREE classification
The safety of this procedure will be evaluated by recording complications perioperatively (Day 1) and post-procedure (Day 30) according to the AGREE criteria and using the PIVI criteria (positive if the complication rate is < 5%).
Measured: Day 1 and Day 30.
Measurement of remission (or regression) of pre-existing comorbidities
Determine the impact on pre-existing metabolic comorbidities :
- Diabetes remission = HbA1C < 6.5%, 3 months after discontinuation of all treatment / Regression or improvement of diabetes involving a decrease of more than 0.5% in HbA1C according to recognized criteria
- Hypertension = Systolic blood pressure (SBP) < 140 mmHg and/or Diastolic blood pressure (DBP) < 90 mmHg without any treatment / Decrease in the number of therapeutic classes;
- Obstructive Sleep Apnea Syndrome (OSAS) = Number of apneas less than 5 without equipment / Decrease in OSAS stage = mild (5 to 15 per hour), moderate (15 to 30), or severe (more than 30) with or without equipment;
- Steatohepatitis = quantification by MRI of the % of fat in the liver with a decrease of more than 30%;
- Dyslipidemia = normalization or improvement of LDL cholesterol and triglyceride levels without the addition of new drug therapies.
Measured: 12 months, 24 months, and 5 years.
Occurrence of metabolic comorbidities
The occurrence of metabolic comorbidities such as diabetes, hypertension (HTN), obstructive sleep apnea syndrome (OSAS), steatohepatitis, and dyslipidemia will be assessed at 12, 24 months, and at the end of the follow-up period. Each comorbidity will be evaluated according to its specific definitional criteria
Measured: 12 months, 24 months, and 5 years
Outpatient procedures
Number of outpatient procedures performed without the need for readmission within 30 days of follow-up
Measured: 30 days
Bariatric procedures performed following the initial intervention
Number and type of bariatric procedures performed following the initial intervention (Redo EndoSleeve, medication treatment such as GLP-1 agonists or equivalent, instrumental treatment with a balloon or other methods)
Measured: Day 1 and Day 30.
Conversion rates in bariatric surgery and their feasibility
Number of conversions to bariatric surgery (Sleeve and bypass) and their feasibility (whether the procedure was possible)
Measured: 3 years and 5 years
Predictive factors for response, weight regain, and plateau at the EndoSleeve
Determination of predictive factors for response, failure (<5% total weight loss at 6 months), weight regain (50% of the lost weight regained at or after one year), and plateau with EndoSleeve (≥10% weight loss but no further loss for more than 3 months)
Measured: 3 months, 6 months and 1 year
Sequence of bariatric procedures that led to the best weight response
Description of the sequence of bariatric procedures leading to the best weight loss outcome after 5 years of follow-up
Measured: 5 years
Measurement of the improvement in quality of life.
Impact on quality of life will be measured through quality of life questionnaires (BAROS questionnaire) before the intervention and during each medical visit, to assess psychological health before and after the intervention.
Measured: 12 months , 24 months, and at 5 years of follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study startDec 2024 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 354 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Société Française d'Endoscopie Digestive
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, VANBIERVLIET, Société Française d'Endoscopie Digestive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06657339
- Sponsor's protocol ID
- SFED-153
- Status last verified
- Oct 2024
- First submitted
- 21 Oct 2024
- Last updated
- 24 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Registry of Obesity Treatment by Endosleeve
- ClinicalTrials.gov ID
- NCT06657339
- Acronym / sponsor ID
- SFED-153
- Conditions
- Obesity
- Keywords
- Endosleeve, Endoscopic gastroplasty, Endoscopic suture
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 354 participants (estimated)
- Lead sponsor
- Société Française d'Endoscopie DigestiveUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 24 Oct 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.
Obesity and overweight have emerged as public health problems of a pandemic nature, significantly reducing the life expectancy of those affected. Obesity has a considerable medico-economic impact, linked to the treatments it requires and its comorbidities. Currently, the prevention of obesity in our Western societies is not effective enough, as the prevalence and incidence of obesity and overweight continue to rise worldwide. In France, the therapeutic management of this condition is governed by the HAS and is summarized as a surgical approach for type 2 obesity with comorbidity or type 3 obesity, with three authorized methods that have shown sufficient evidence: gastric banding, sleeve gastrectomy (or longitudinal sleeve gastrectomy), and Roux-en-Y gastric bypass.
With the advent of organ-preserving interventional endoscopy, the systematic use of these surgical methods, although effective for total weight loss and excess weight loss, raises questions. Indeed, these new therapeutic endoscopic approaches, which are less invasive, less costly, and respectful of anatomy, currently show convincing cohort results in the short term (12 to 24 months) and require confirmation of their effectiveness and safety in the long term (5 years) so that they can become first-line therapeutic methods in the near future. At the request of the HAS in its self-referral of 2020 and then in 2022, this prospective registry aims to confirm the effectiveness and safety of the endosleeve (or endoscopic sleeve) in the long-term therapeutic management of obesity within the framework of everyday practice in national reference centers for obesity treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic sleeve gastroplasty | – | Procedure: Therapeutic endoscopy endosleeve using a gastric suturing device (OverStitch™/Endomina™)Therapeutic endoscopy using a gastric suturing device (OverStitch™/Endomina™) according to the practices of the investigating center |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any referred patient with obesity and a BMI > 30 kg/m² who meets the inclusion criteria and is considered suitable for therapeutic management of obesity will be invited to participate in the study at the investigating centers
Key inclusion criteria (3 listed)
- Age over 18 years;
- Patient with a body mass index (BMI) ≥ 30 kg/m²;
- Signed informed consent
Key exclusion criteria (16 listed)
- Contraindication to performing an upper endoscopy or using an endoscopic plication system according to the instructions for use (IFU);
- Presence of an ulcer in the gastric body or fundus;
- Achalasia, severe esophagitis (Los Angeles grade C or D);
- ENT or esophageal malformation;
- Gastrointestinal disease (including stenosis), history of previous gastric surgery (including bariatric surgery, previous endoscopic gastroplasty);
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 |
|---|---|---|
| Therapeutic endoscopy endosleeve using a gastric suturing device (OverStitch™/Endomina™)The patient will undergo therapeutic endoscopy under general anesthesia, either as outpatient or inpatient care, based on the recommendations of the investigating physician, taking into account anesthetic risks and comorbidities. Two CE-marked gastric suturing devices may be used at the discretion of the investigating center based on their practices OverStich™ allows for tissue fixation via a gastroscope, creating a durable suture through a transabdominal fixation technique. The procedure lasts about 45 minutes and includes measures to prevent vomiting. Endomina™ is a single-use device that captures the gastric mucosa to create successive plications, allowing for effective suturing along the greater curvature of the stomach. | Procedure or surgery | Endoscopic sleeve gastroplasty |
Primary outcome
Measurement of total weight loss (TWL) in % 5 years afther endosleeve
Time frame: 5 years
To determine the proportion of patients who met the PIVI criteria after endosleeve without additional techniques
11 secondary outcomes
Measurement of total weight loss (TWL) in %
Time frame: 12 et 24 months
Measurement excess weight loss after the endosleeve intervention.
Time frame: 12, 24 months, and 5 years
Measurement of the percentage of postoperative complications according to the AGREE classification
Time frame: Day 1 and Day 30.
Measurement of remission (or regression) of pre-existing comorbidities
Time frame: 12 months, 24 months, and 5 years.
Occurrence of metabolic comorbidities
Time frame: 12 months, 24 months, and 5 years
Outpatient procedures
Time frame: 30 days
Bariatric procedures performed following the initial intervention
Time frame: Day 1 and Day 30.
Conversion rates in bariatric surgery and their feasibility
Time frame: 3 years and 5 years
Predictive factors for response, weight regain, and plateau at the EndoSleeve
Time frame: 3 months, 6 months and 1 year
Sequence of bariatric procedures that led to the best weight response
Time frame: 5 years
Measurement of the improvement in quality of life.
Time frame: 12 months , 24 months, and at 5 years of follow-up.
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 24 Oct 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Société Française d'Endoscopie Digestive.
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 16 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: opening soon, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Measurement of total weight loss (TWL) in % 5 years afther endosleeve (time frame: 5 years). 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 24 Oct 2024.