Morbid ObesityESG-IRMNCT04945473
Gastric Recalibration After Endoscopic Sleeve Gastroplasty
A study testing Endoscopic placement of additional sutures in people with Morbid Obesity, run by IHU Strasbourg at 1 site in France.
Trial summary
Endoscopic sleeve gastroplasty (ESG) is a technique used for bariatric surgery, with results comparable to conventional surgery, in order to treat morbid obesity. It has also less risks of complications, and it is not an irreversible technique. It can be repeated overtime, regarding the evolution of the gastroplasty. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Endoscopic placement of additional sutures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jul 2021to Sep 2026
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 75
- Patients with morbid obesity (BMI≥ 30 with comorbidities or> 40)
- Patients with obesity for more than 2 years
- Failure of medical treatment of obesity
- Patients who may benefit from general anaesthesia
- Patient able to participate in all aspects of the study and that agree to comply with all study requirements, for the duration of the study. This includes the availability of reliable transportation and sufficient time to attend all follow-up visits.
- Patient able to fully understand the study and ready to give consent to participate to the study.
- Patient affiliated to the French social security system
Who cannot join
- Patient with a contraindication to perform an ESG
- Patient with a history of previous bariatric, gastric or esophageal surgery.
- Patient who initiated medical therapy within the last 3 months, with evidence of weight gain.
- Patient with an uncontrolled, poorly controlled, or suspected history of eating disorders or psychiatric illness.
- Patient with unstable and precarious state of health, as determined and assessed by the investigator.
- Patient who is pregnant, breastfeeding or of childbearing age and without effective contraception.
Show all 11Show fewer
- Patient in exclusion period (determined by a previous or ongoing study)
- Patient under legal protection
- Patient under guardianship or curatorship
- Patients with a BMI less than 30 at 6 months after ESG. These patients will not be candidate for revision regardless of the randomization group.
- Patients with a contraindication to MRI may be included in the study and will follow the "No Imaging" study design.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de chirurgie digestive et endocrinienne, NHC
Strasbourg, 67000
Silvana PERRETTA, MD, PHD, silvana.perretta@ircad.fr
About this study
Official title: Assessment of the Impact of Endoscopic Gastric Revision by Application of Additional Sutures on Weight Loss After Endoscopic Sleeve Gastroplasty in Obese Patients
Endoscopic sleeve gastroplasty (ESG) is a technique used for bariatric surgery, with results comparable to conventional surgery, in order to treat morbid obesity. It has also less risks of complications, and it is not an irreversible technique. It can be repeated overtime, regarding the evolution of the gastroplasty. There is little data in the literature on the effectiveness of endoscopic "revision". This study will assess the benefits and costs of a revision during the follow-up endoscopy.
Read the detailed description
Obesity is a health dilemma with an increased risk of premature death. Bariatric surgery is considered to be the most effective and durable treatment for morbid obesity as compared to other available options. However, only the most severe cases, namely class III or class II patients with obesity-related comorbidities fit the criteria for bariatric surgical interventions and are offered these options. Endoscopic sleeve gastroplasty (ESG) is a restrictive procedure based on the tubulization and shortening of the stomach, achieved by means of multiple full-thickness sutures applied endoscopically. ESG offers the possibility to obtain results (weight loss, improvement of comorbidities and quality of life) comparable to conventional surgery while reducing the risk of complications. One of the major advantages of this technique is that it does not make irreversible changes to gastric anatomy and function and can be repeated overtime if needed placing additional sutures. ESG appearance might be subject to changes overtime. In fact, depending on the sutures' integrity, the gastroplasty can be regarded as tight, partially open or completely open. Very little data currently exists in the literature on the effectiveness of endoscopic "revision" with the placement of additional sutures on weight loss and its impact on co-morbidities. In order to objectively assess the benefits and costs of a revision during the follow-up endoscopy patients who present a TWL <10% or a BMI greater than 30 at 6 months from the primary ESG, will be randomized into 2 groups: a "Revision" group in which a revision will be performed systematically in the event of suture disruption at the control EGD, and a "Control" group which will only benefit of a control endoscopy regardless of the state of the gastroplasty.
- Conditions
- Morbid Obesity
- Being tested
- Endoscopic placement of additional sutures
- Keywords
- obesity, Endoscopy, ESG, Gastric emptying, Revision procedure
- Medical subject headings
- Obesity, Morbid, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic placement of additional suturesProcedure or surgery
A new endoscopic suture will be performed in case of a BMI≥30 or total weight loss (TBWL) less than 10%, and relaxation of gastric tubulization during the regular endoscopic follow-up after 6 months from the ESG. The same endoscopic suture technique of the primary ESG will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Revision | Experimental | BMI≥30 or total weight loss (TBWL) < 10% and relaxation of gastric tubulisation at 6 months after ESG.
Additional stitches will be placed during the follow-up gastroscopy at 6 months. Receives: Procedure: Endoscopic placement of additional sutures |
| Without revision | No intervention | The control gastroscopy will be performed without any additional procedure (no additional stitches). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total weight loss (TWL)
The primary endpoint is the assessment of weight evolution in terms of total weight loss (TWL) between the two randomized groups ("Control" vs. "Review"). The evolution of the TWL will be assessed at 3, 6, 12 ,18 and 24 months after the ESG.
Measured: 3, 6, 12, 18 and 24 months after the ESG
Secondary outcomes (9)
Excess weight loss (EWL)
Evaluation of weight loss in terms of excess body weight evolution (EWL) between the two randomized groups ("Control" vs. "Review"). The evolution of the EWL will be assessed at 3, 6, 12 ,18 and 24 months after the ESG.
Measured: The data will be collected at the follow-up consultation, specifically at 3, 6, 12, 18 and 24 months after the ESG
Body mass index (BMI)
Evaluation of the weight loss in terms of body mass index (BMI) between the two randomized groups. The evolution of the BMI will be assessed at 3, 6, 12 ,18 and 24 months after the ESG.
Measured: The data will be collected at the follow-up consultation, specifically at 3, 6, 12, 18 and 24 months after the ESG
Self-esteem and activities evaluation
Assessment of the self-esteem and activities before and after the ESG, using the Moorehead-Ardelt quality of life questionnaire II. Score range from -3.0 to 3.0.
- Score from -3.0 to -2.1: very poor quality of life
- Score from -2.0 to -1.1: poor quality of life
- Score from -1.0 to 1.0: fair quality of life
- Score from 1.1 to 2.0: good quality of life
- Score from 2.1 to 3.0: very good quality of life. The evolution of will be assessed at 3, 6, 12 ,18 and 24 months after the ESG.
Measured: The data will be collected at the follow-up consultation, specifically at 3, 6, 12, 18 and 24 months after the ESG
Gastrointestinal quality of life evaluation
Assessment of the gastrointestinal quality of life before and after the ESG, using GIQLI (GastroIntestinal Quality of Life Index) questionnaire. There are 36 questions, each ranged from 0 to 4. A global score >125 is considered as normal. The evolution of the gastrointestinal quality of life will be assessed at 3, 6, 12 ,18 and 24 months after the ESG.
Measured: The data will be collected at the follow-up consultation, specifically at 3, 6, 12, 18 and 24 months after the ESG
Comorbidity evolution
Assessment of comorbidities by comparing the evolution of comorbidities (hypertension, diabetes, sleep apnea syndrome, GERD with the questionnaire "GERD-Health Related Quality of Life Questionnaire GERD-HRQL", knee osteoarthritis) before and after the ESG. GERD-HRQL questionnaire contains 16 questions, ranged from 0 to 5. The higher the score is, the more important the gastroesophageal reflux is. The evolution of comorbidities will be assessed at 3, 6, 12 ,18 and 24 months after the ESG.
Measured: The data will be collected at the follow-up consultation, specifically at 3, 6, 12, 18 and 24 months after the ESG
Gastric Emptying evaluation
Evaluation of gastric volume and emptying changes before and after ESG. The evaluation will be carried out performing a dynamic MRI before and 7 months after ESG. Dynamic MRI changes will be put in correlation with weight modifications (TWL, EWL and BMI).
Measured: The data will be collected before and 7 months after the ESG
Gastric Emptying evaluation
Evaluation of gastric volume and emptying changes before and after ESG. The evaluation will be carried out performing a dynamic MRI before and 7 months after ESG. Dynamic MRI changes will be put in correlation with changes in secretion of intestinal hormones and glycemic profile (blood sugar, HbA1c, insulin, ghrelin, C-peptide, GLP-1 and Glucagon).
Measured: The data will be collected before and 7 months after the ESG
Gastric Emptying evaluation
Evaluation of changes in gastric volume and gastric emptying comparing the results obtained by dynamic MRI between the two randomized groups ("Control" vs. "Revision"), with an additional correlation study of these results with weight loss: total weight lost (TWL%), excess weight loss (EWL%) and change in BMI. The data will be collected before ESG, and at 3, 6, 12, 18 and 24 months after ESG
Measured: The data will be collected before and 7 months after the ESG
Gastric Emptying evaluation
Evaluation of changes in gastric volume and gastric emptying comparing the results obtained by dynamic MRI between the two randomized groups ("Control" vs. "Revision"), with an additional correlation study of these results with changes in secretion of intestinal hormones and glycemic profile (blood sugar, HbA1c, insulin, ghrelin, C-peptide, GLP-1 and Glucagon). The data will be collected before and 7 months after the ESG.
Measured: The data will be collected before and 7 months after the ESG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start13 Jul 2021
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
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, NHC, Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04945473
- Sponsor's protocol ID
- 20-006
- Acronym
- ESG-IRM
- Status last verified
- Apr 2025
- First submitted
- 8 Jun 2021
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Willett WC, Dietz WH, Colditz GA. Guidelines for healthy weight. N Engl J Med. 1999 Aug 5;341(6):427-34. doi: 10.1056/NEJM199908053410607. No abstract available.
PubMed 10432328Sharaiha 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 25380510Lopez-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 26878054Lopez-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 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 25380508Abu 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 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Impact of Endoscopic Gastric Revision by Application of Additional Sutures on Weight Loss After Endoscopic Sleeve Gastroplasty in Obese Patients
- ClinicalTrials.gov ID
- NCT04945473
- Acronym / sponsor ID
- ESG-IRM / 20-006
- Conditions
- Morbid Obesity
- Keywords
- obesity, Endoscopy, ESG, Gastric emptying, Revision procedure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IHU StrasbourgUniversity, hospital or other
- Study start
- 13 Jul 2021 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 30 Jun 2021 (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.
Endoscopic sleeve gastroplasty (ESG) is a technique used for bariatric surgery, with results comparable to conventional surgery, in order to treat morbid obesity. It has also less risks of complications, and it is not an irreversible technique. It can be repeated overtime, regarding the evolution of the gastroplasty. There is little data in the literature on the effectiveness of endoscopic "revision". This study will assess the benefits and costs of a revision during the follow-up endoscopy.
Detailed description
Obesity is a health dilemma with an increased risk of premature death. Bariatric surgery is considered to be the most effective and durable treatment for morbid obesity as compared to other available options. However, only the most severe cases, namely class III or class II patients with obesity-related comorbidities fit the criteria for bariatric surgical interventions and are offered these options. Endoscopic sleeve gastroplasty (ESG) is a restrictive procedure based on the tubulization and shortening of the stomach, achieved by means of multiple full-thickness sutures applied endoscopically. ESG offers the possibility to obtain results (weight loss, improvement of comorbidities and quality of life) comparable to conventional surgery while reducing the risk of complications. One of the major advantages of this technique is that it does not make irreversible changes to gastric anatomy and function and can be repeated overtime if needed placing additional sutures. ESG appearance might be subject to changes overtime. In fact, depending on the sutures' integrity, the gastroplasty can be regarded as tight, partially open or completely open. Very little data currently exists in the literature on the effectiveness of endoscopic "revision" with the placement of additional sutures on weight loss and its impact on co-morbidities. In order to objectively assess the benefits and costs of a revision during the follow-up endoscopy patients who present a TWL <10% or a BMI greater than 30 at 6 months from the primary ESG, will be randomized into 2 groups: a "Revision" group in which a revision will be performed systematically in the event of suture disruption at the control EGD, and a "Control" group which will only benefit of a control endoscopy regardless of the state of the gastroplasty.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Revision | Experimental | Procedure: Endoscopic placement of additional suturesBMI≥30 or total weight loss (TBWL) < 10% and relaxation of gastric tubulisation at 6 months after ESG. Additional stitches will be placed during the follow-up gastroscopy at 6 months. |
| Without revision | No intervention | –The control gastroscopy will be performed without any additional procedure (no additional stitches). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients aged 18 to 75
- Patients with morbid obesity (BMI≥ 30 with comorbidities or> 40)
- Patients with obesity for more than 2 years
- Failure of medical treatment of obesity
- Patients who may benefit from general anaesthesia
Key exclusion criteria (11 listed)
- Patient with a contraindication to perform an ESG
- Patient with a history of previous bariatric, gastric or esophageal surgery.
- Patient who initiated medical therapy within the last 3 months, with evidence of weight gain.
- Patient with an uncontrolled, poorly controlled, or suspected history of eating disorders or psychiatric illness.
- Patient with unstable and precarious state of health, as determined and assessed by the investigator.
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 placement of additional suturesA new endoscopic suture will be performed in case of a BMI≥30 or total weight loss (TBWL) less than 10%, and relaxation of gastric tubulization during the regular endoscopic follow-up after 6 months from the ESG. The same endoscopic suture technique of the primary ESG will be applied. | Procedure or surgery | Revision |
Primary outcome
Total weight loss (TWL)
Time frame: 3, 6, 12, 18 and 24 months after the ESG
The primary endpoint is the assessment of weight evolution in terms of total weight loss (TWL) between the two randomized groups ("Control" vs. "Review"). The evolution of the TWL will be assessed at 3, 6, 12 ,18 and 24 months after the ESG.
9 secondary outcomes
Excess weight loss (EWL)
Time frame: The data will be collected at the follow-up consultation, specifically at 3, 6, 12, 18 and 24 months after the ESG
Body mass index (BMI)
Time frame: The data will be collected at the follow-up consultation, specifically at 3, 6, 12, 18 and 24 months after the ESG
Self-esteem and activities evaluation
Time frame: The data will be collected at the follow-up consultation, specifically at 3, 6, 12, 18 and 24 months after the ESG
Gastrointestinal quality of life evaluation
Time frame: The data will be collected at the follow-up consultation, specifically at 3, 6, 12, 18 and 24 months after the ESG
Comorbidity evolution
Time frame: The data will be collected at the follow-up consultation, specifically at 3, 6, 12, 18 and 24 months after the ESG
Gastric Emptying evaluation
Time frame: The data will be collected before and 7 months after the ESG
Gastric Emptying evaluation
Time frame: The data will be collected before and 7 months after the ESG
Gastric Emptying evaluation
Time frame: The data will be collected before and 7 months after the ESG
Gastric Emptying evaluation
Time frame: The data will be collected before and 7 months after the ESG
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 1 May 2025.
- Background: PubMed 10432328Willett WC, Dietz WH, Colditz GA. Guidelines for healthy weight. N Engl J Med. 1999 Aug 5;341(6):427-34. doi: 10.1056/NEJM199908053410607. No abstract available.
- 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 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 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 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 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.
Silvana PERRETTA, MD, PHD principal investigator
Service de chirurgie digestive et endocrinienne, NHC, Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic placement of additional sutures in people with 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 8 inclusion and 11 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 1 May 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?
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 Pierre GOEPFERT (0390413646, pierre.goepfert@ihu-strasbourg.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total weight loss (TWL) (time frame: 3, 6, 12, 18 and 24 months after the ESG). 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 NCT04945473, which also lists 6 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 1 May 2025.