Endoscopic Gastric Tubulization (Endosleeve)

Endoscopic gastric tubulization is currently proposed in the Digestive Surgery Department of the Nouvel Hôpital Civil, Strasbourg, France, to adult patients with morbid obesity. The procedure is performed using the CE marked endoscopic suture device Overstitch (Apollo Endosurgery, Austin, Tx. USA). It is standard practice since October 2016.

The objective of this study is to prospectively collect data of patients who underwent an endoscopic gastric tubulization, from last visit before procedure to 2 years after procedure. These data are usually collected during medical consultations and will enable the evaluation of weight loss, quality of life and comorbidities improvement, reproducibility and durability of the technique.

Study Overview

• Status: Recruiting
• Conditions: Morbid Obesity
• Intervention / Treatment: Procedure: Endoscopic gastric tubulization

Detailed Description

Gastric restriction is one of the fundamental principles of gastric bypass and gastric banding. Despite its advantages (long term weight loss, comorbidities related to obesity improvement…), bariatric surgery is risky. In fact, complications putting the patient into a life-threatening condition can occur. Endoscopic approaches are similar to current surgical methods but less invasive, safer and allow ambulatory care.

Nowadays, practitioners have the possibility to reduce stomach size by merging tissues through an endoscopic endoluminal suture approach without any incision. This leads to similar results (gastric restriction, weight loss, quality of life and comorbidities improvement) compared with standard surgical procedure while reducing the risk of complications.

One of the major benefit of this technique is its reversibility. A new surgical or endoscopic procedure is possible at a later stage.

Endoscopic gastric tubulization is currently proposed in the Digestive Surgery Department of the Nouvel Hôpital Civil, Strasbourg, France, to adult patients with morbid obesity. The procedure is performed using the CE marked endoscopic suture device Overstitch (Apollo Endosurgery, Austin, Tx. USA). It is standard practice since October 2016.

The objective of this study is to prospectively collect data of patients who underwent an endoscopic gastric tubulization, from last visit before procedure to 2 years after procedure. These data are usually collected during medical consultations and will enable the evaluation of weight loss, quality of life and comorbidities improvement, reproducibility and durability of the technique.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Silvana Perretta, MD, PhD; Phone Number: + 33 3 69 55 05 31; Email: silvana.perretta@ircad.fr
• Study Contact Backup: Name: Michel Vix, MD; Phone Number: + 33 3 69 55 13 03; Email: michel.vix@chru-strasbourg.fr

Study Locations

• France
  • Strasbourg, France, 67091
    • Recruiting
    • Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil
    • Contact: Silvana Perretta, MD, PhD; Phone Number: + 33 3 69 55 05 31; Email: silvana.perretta@ircad.fr
    • Contact: Michel Vix, MD; Phone Number: +33 3 69 55 13 09; Email: michel.vix@chru-strasbourg.fr
    • Principal Investigator: Silvana Perretta, MD, PhD
    • Sub-Investigator: Antonio D'Urso, MD
    • Principal Investigator: Michel Vix, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients over 18 years old requiring a treatment for morbid obesity.

Description

Inclusion Criteria:

• Patients scheduled for an endoscopic gastric tubulization in the Nouvel Hôpital Civil, Strasbourg, France

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Endoscopic gastric tubulization; Endoscopic gastric tubulization is performed using the CE marked endoscopic suture device Overstitch (Apollo Endosurgery, Austin, Tx. USA).	Procedure: Endoscopic gastric tubulization; Endoscopic gastric tubulization is performed using the CE marked endoscopic suture device Overstitch (Apollo Endosurgery, Austin, Tx. USA).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in weight loss	Change in weight loss measured in kilograms.	7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure
Change in excess weight loss	Change in excess weight loss measured in percentage. Excess weight loss = (weight loss at time point / weight loss goal to reach a body mass index of 25 kg/m²) x 100	7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure
Change in body mass index variation	Change in body mass index variation measured in kg/m².	7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with procedure-related adverse event	Number of patients with procedure-related adverse event within 12 months after procedure.	7 days, 1 - 3 - 6 - 9 and 12 months after procedure
Comorbidities improvement	Improvement of sleep apnea, arterial hypertension, diabetes, reflux, osteoarticular disorders compared with preoperative data.	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 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.	3 - 12 - 18 and 24 months after procedure
Gastro-intestinal quality of life improvement	Improvement of quality of life assessed by the Gastro-Intestinal Quality of Life Index questionnaire. A global score > 125 is considered as normal.	3 - 12 - 18 and 24 months after procedure
Modification in the feeling of satiety	Satiety assessed by Three Factors Eating Questionnaire - R18. Three dimensions are assessed. The higher the score is, the more important the dimension is.; Restrained eating: score from 6 to 24; Uncontrolled eating: score from 9 to 36; Emotional eating: score from 3 to 12.	1 - 3 - 6 - 12 - 18 and 24 months after procedure
Upper GI tract radiologic evaluation	Upper GI control series.	1 day, 6 - 12 and 24 months after procedure
Upper GI tract endoscopic evaluation	Upper GI control gastroscopy.	6 - 12 and 24 months after procedure
Procedure duration	Time required to perform the endoscopic gastric tubulization.	At time of procedure
Number of stitches in place	Number of stitches put in place during the endoscopic gastric tubulization.	At time of procedure

Collaborators and Investigators

• Sponsor: IHU Strasbourg
• Investigators: Principal Investigator: Michel Vix, MD, Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil - Strasbourg; Principal Investigator: Silvana Perretta, MD, PhD, Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil - Strasbourg

Publications and helpful links

General 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.
• Lopez-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.
• Lopez-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.
• Sharaiha 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.
• Abu 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2018
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: May 16, 2018
• First Submitted That Met QC Criteria: June 12, 2018
• First Posted (Actual): June 13, 2018

Study Record Updates

• Last Update Posted (Actual): May 1, 2025
• Last Update Submitted That Met QC Criteria: April 29, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Quality of life; Weight loss; Endoscopic gastric tubulization
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Obesity, Morbid
• Other Study ID Numbers: 16-001-OBS (CPP); 2017-A03599-44 (Other Identifier: ANSM France)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No