Morbid ObesityEndosleeveNCT02948621
Endoscopic Sleeve Gastroplasty
An observational study of Morbid Obesity, run by IHU Strasbourg at 1 site in France.
Trial summary
The endoscopic sleeve gastroplasty allows stomach size reduction through an endoluminal suture approach without any incision. It could reduce the complications associated with current surgical techniques while obtaining the target gastric restriction, weight loss, comorbidities and quality of life improvement. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Endoscopic sleeve gastroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2016to May 2020
- Phase
- Observational
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients over 18 years old requiring a treatment for morbid obesity.
Who may be able to join
- Patient > 18 years old and < 60 years old
- Patient with morbid obesity for at least 2 years
- Patient who failed medical and diet treatment of obesity
- Patient with no contraindication to anesthesia
- Patient able to understand the study and to provide informed consent.
Who cannot join
- Patient with inflammatory, tumoral or bad quality tissues at endoscopy
- Patient with a history of gastro-intestinal inflammatory disease, stenosis or intestinal adhesions, kidney or liver failure, chronic pancreatic disease
- Patient with a history and/or signs and/or symptoms of gastroduodenal ulcerous disease and/or progressive gastroduodenal ulcerous disease
- Patient with an oesophageal pathology as Zenker's diverticulum, peptic oesophagitis stage 3-4, oesophageal stenosis, Barrett syndrome, oesophageal cancer, dysphagia, achalasia
- Patient with previous bariatric, gastric or oesophageal surgery, intestinal obstruction, portal hypertension, gastro-intestinal tumors, oesophageal or gastric varices, gastroparesis
- Patient with a severe coagulopathy (prothrombin time > 3 seconds or thrombocytic count < 50 000/mm3) or treated with heparin, coumadin, warfarin or any other anticoagulants and drugs preventing coagulation or platelet aggregation, except aspirin and nonsteroidal anti-inflammatory drugs
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- Pregnancy, breastfeeding or woman without contraception
- Patient with a congestive heart failure, arrhythmia or unstable coronary heart disease
- Patient using or having used diet drugs within the last 30 days or intending to use them during study follow-up
- Patient under drug treatment within the last 3 months known to induce weight gain
- Patient with eating disorders or uncontrolled, poorly controlled or suspected psychiatric disease
- Patient in a poor condition according to investigator
- Patient in exclusion period (determined by a previous study or in progress)
- Patient with significative weight loss between date of enrollment in the study and date of procedure
- Patient with a systemic infection the day of procedure.
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil de Strasbourg
Strasbourg, 67000
About this study
The endoscopic sleeve gastroplasty allows stomach size reduction through an endoluminal suture approach without any incision. It could reduce the complications associated with current surgical techniques while obtaining the target gastric restriction, weight loss, comorbidities and quality of life improvement.
The primary objective of this study is to assess weight loss after endoscopic sleeve gastroplasty in patients with morbid obesity.
Read the detailed description
Gastric restriction is one of the fundamental principles of gastric bypass and gastric banding. Nowadays, practitioners have the possibility to reduce stomach size by merging tissues through an endoscopic endoluminal suture approach without any incision. This could reduce the complications associated with current surgical techniques while obtaining the target gastric restriction, weight loss, comorbidities and quality of life improvement.
The primary objective of this study is to assess weight loss after endoscopic sleeve gastroplasty in patients with morbid obesity according to the technique described in the literature: reduction of the gastric pouch into a sleeve structure by modification of the stomach greater curvature thanks to a plication.
- Conditions
- Morbid Obesity
- Being tested
- Endoscopic sleeve gastroplasty
- Keywords
- Endoscopic sleeve gastroplasty, Excess weight loss, Quality of life
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic sleeve gastroplastyProcedure or surgery
Endoscopic sleeve gastroplasty is performed using a CE marked endoscopic suture device (Overstitch, Apollo Endosurgery, Austin, Tx. USA). Continuous stitches are placed to create a sleeve-shaped gastric path of 2 cm diameter to reduce stomach volume from the proximal antrum to the oeso-gastric junction.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic sleeve gastroplasty | Endoscopic sleeve gastroplasty is performed using a CE marked endoscopic suture device (Overstitch, Apollo Endosurgery, Austin, Tx. USA). Continuous stitches are placed to create a sleeve-shaped gastric path of 2 cm diameter to reduce stomach volume from the proximal antrum to the oeso-gastric junction. Receives: Procedure: Endoscopic sleeve gastroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Measured: 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure
Excess weight loss
Measured: 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure
Body mass index variation
Measured: 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure
Secondary outcomes (4)
Procedure reproducibility
Absence of adverse event within 12 months after procedure.
Measured: 7 days, 1 - 3 - 6 - 9 and 12 months after procedure
Comorbidities improvement
Improvement of hyperlipidemia, arterial hypertension, diabetes, reflux, osteoarticular disorders compared with preoperative data.
Measured: 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure
Quality of life improvement
Improvement of quality of life assessed by Moorehead-Ardelt Quality of life II questionnaire and Gastro-intestinal Quality of Life Index questionnaire.
Measured: 3 - 12 - 18 and 24 months after procedure
Modification in the feeling of satiety
Satiety assessed by Three Factors Eating Questionnaire - R18.
Measured: 1 - 3 - 6 - 12 - 18 and 24 months after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionMay 2018
- Study completionMay 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Morbid 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- IHU Strasbourg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Silvana Perretta, MD, PhD, Principal investigator, Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil de StrasbourgMichel Vix, MD, Principal investigator, Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02948621
- Sponsor's protocol ID
- 16-001-OBS
- Acronym
- Endosleeve
- Status last verified
- Jan 2024
- First submitted
- 26 Oct 2016
- Last updated
- 8 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lopez-Nava G, Galvao MP, da Bautista-Castano I, Jimenez A, De Grado T, Fernandez-Corbelle JP. Endoscopic sleeve gastroplasty for the treatment of obesity. Endoscopy. 2015 May;47(5):449-52. doi: 10.1055/s-0034-1390766. Epub 2014 Nov 7.
PubMed 25380508Lopez-Nava G, Galvao MP, Bautista-Castano I, Jimenez-Banos A, Fernandez-Corbelle JP. Endoscopic Sleeve Gastroplasty: How I Do It? Obes Surg. 2015 Aug;25(8):1534-8. doi: 10.1007/s11695-015-1714-7.
PubMed 26003549Lopez-Nava G, Galvao M, Bautista-Castano I, Fernandez-Corbelle JP, Trell M. Endoscopic sleeve gastroplasty with 1-year follow-up: factors predictive of success. Endosc Int Open. 2016 Feb;4(2):E222-7. doi: 10.1055/s-0041-110771. Epub 2016 Jan 15.
PubMed 26878054Sharaiha RZ, Kedia P, Kumta N, DeFilippis EM, Gaidhane M, Shukla A, Aronne LJ, Kahaleh M. Initial experience with endoscopic sleeve gastroplasty: technical success and reproducibility in the bariatric population. Endoscopy. 2015 Feb;47(2):164-6. doi: 10.1055/s-0034-1390773. Epub 2014 Nov 7.
PubMed 25380510Abu Dayyeh BK, Rajan E, Gostout CJ. Endoscopic sleeve gastroplasty: a potential endoscopic alternative to surgical sleeve gastrectomy for treatment of obesity. Gastrointest Endosc. 2013 Sep;78(3):530-5. doi: 10.1016/j.gie.2013.04.197. Epub 2013 May 24.
PubMed 23711556
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Sleeve Gastroplasty
- ClinicalTrials.gov ID
- NCT02948621
- Acronym / sponsor ID
- Endosleeve / 16-001-OBS
- Conditions
- Morbid Obesity
- Keywords
- Endoscopic sleeve gastroplasty, Excess weight loss, Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- IHU StrasbourgUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 28 Oct 2016 (estimated)
- 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 endoscopic sleeve gastroplasty allows stomach size reduction through an endoluminal suture approach without any incision. It could reduce the complications associated with current surgical techniques while obtaining the target gastric restriction, weight loss, comorbidities and quality of life improvement.
The primary objective of this study is to assess weight loss after endoscopic sleeve gastroplasty in patients with morbid obesity.
Detailed description
Gastric restriction is one of the fundamental principles of gastric bypass and gastric banding. Nowadays, practitioners have the possibility to reduce stomach size by merging tissues through an endoscopic endoluminal suture approach without any incision. This could reduce the complications associated with current surgical techniques while obtaining the target gastric restriction, weight loss, comorbidities and quality of life improvement.
The primary objective of this study is to assess weight loss after endoscopic sleeve gastroplasty in patients with morbid obesity according to the technique described in the literature: reduction of the gastric pouch into a sleeve structure by modification of the stomach greater curvature thanks to a plication.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic sleeve gastroplasty | – | Procedure: Endoscopic sleeve gastroplastyEndoscopic sleeve gastroplasty is performed using a CE marked endoscopic suture device (Overstitch, Apollo Endosurgery, Austin, Tx. USA). Continuous stitches are placed to create a sleeve-shaped gastric path of 2 cm diameter to reduce stomach volume from the proximal antrum to the oeso-gastric junction. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients over 18 years old requiring a treatment for morbid obesity.
Key inclusion criteria (5 listed)
- Patient > 18 years old and < 60 years old
- Patient with morbid obesity for at least 2 years
- Patient who failed medical and diet treatment of obesity
- Patient with no contraindication to anesthesia
- Patient able to understand the study and to provide informed consent.
Key exclusion criteria (15 listed)
- Patient with inflammatory, tumoral or bad quality tissues at endoscopy
- Patient with a history of gastro-intestinal inflammatory disease, stenosis or intestinal adhesions, kidney or liver failure, chronic pancreatic disease
- Patient with a history and/or signs and/or symptoms of gastroduodenal ulcerous disease and/or progressive gastroduodenal ulcerous disease
- Patient with an oesophageal pathology as Zenker's diverticulum, peptic oesophagitis stage 3-4, oesophageal stenosis, Barrett syndrome, oesophageal cancer, dysphagia, achalasia
- Patient with previous bariatric, gastric or oesophageal surgery, intestinal obstruction, portal hypertension, gastro-intestinal tumors, oesophageal or gastric varices, gastroparesis
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 |
|---|---|---|
| Endoscopic sleeve gastroplastyEndoscopic sleeve gastroplasty is performed using a CE marked endoscopic suture device (Overstitch, Apollo Endosurgery, Austin, Tx. USA). Continuous stitches are placed to create a sleeve-shaped gastric path of 2 cm diameter to reduce stomach volume from the proximal antrum to the oeso-gastric junction. | Procedure or surgery | Endoscopic sleeve gastroplasty |
Primary outcome
Weight loss
Time frame: 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure
Excess weight loss
Time frame: 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure
Body mass index variation
Time frame: 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure
4 secondary outcomes
Procedure reproducibility
Time frame: 7 days, 1 - 3 - 6 - 9 and 12 months after procedure
Comorbidities improvement
Time frame: 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure
Quality of life improvement
Time frame: 3 - 12 - 18 and 24 months after procedure
Modification in the feeling of satiety
Time frame: 1 - 3 - 6 - 12 - 18 and 24 months after procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
- Background: PubMed 25380508Lopez-Nava G, Galvao MP, da Bautista-Castano I, Jimenez A, De Grado T, Fernandez-Corbelle JP. Endoscopic sleeve gastroplasty for the treatment of obesity. Endoscopy. 2015 May;47(5):449-52. doi: 10.1055/s-0034-1390766. Epub 2014 Nov 7.
- Background: PubMed 26003549Lopez-Nava G, Galvao MP, Bautista-Castano I, Jimenez-Banos A, Fernandez-Corbelle JP. Endoscopic Sleeve Gastroplasty: How I Do It? Obes Surg. 2015 Aug;25(8):1534-8. doi: 10.1007/s11695-015-1714-7.
- Background: PubMed 26878054Lopez-Nava G, Galvao M, Bautista-Castano I, Fernandez-Corbelle JP, Trell M. Endoscopic sleeve gastroplasty with 1-year follow-up: factors predictive of success. Endosc Int Open. 2016 Feb;4(2):E222-7. doi: 10.1055/s-0041-110771. Epub 2016 Jan 15.
- Background: PubMed 25380510Sharaiha RZ, Kedia P, Kumta N, DeFilippis EM, Gaidhane M, Shukla A, Aronne LJ, Kahaleh M. Initial experience with endoscopic sleeve gastroplasty: technical success and reproducibility in the bariatric population. Endoscopy. 2015 Feb;47(2):164-6. doi: 10.1055/s-0034-1390773. Epub 2014 Nov 7.
- Background: PubMed 23711556Abu Dayyeh BK, Rajan E, Gostout CJ. Endoscopic sleeve gastroplasty: a potential endoscopic alternative to surgical sleeve gastrectomy for treatment of obesity. Gastrointest Endosc. 2013 Sep;78(3):530-5. doi: 10.1016/j.gie.2013.04.197. Epub 2013 May 24.
- Individual participant dataSharing planned: No
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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.
Silvana Perretta, MD, PhD principal investigator
Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil de Strasbourg
Michel Vix, MD principal investigator
Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Morbid Obesity, run by IHU Strasbourg 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 5 inclusion and 15 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: finished, as of the sponsor's last update on 8 Jan 2024. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Weight loss (time frame: 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure). The study lists 3 primary outcomes in all. 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 NCT02948621, which also lists 5 linked publications.
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 8 Jan 2024.