Endoscopic Gastric Tubulization

NCT03554902 | Recruiting

• 2 other identifiers: 16-001-OBS (CPP)2017-A03599-44
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Morbid Obesity

Keywords

Endoscopic gastric tubulization; Weight loss; Quality of life

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Number of patients with procedure-related adverse event

  7 days, 1 - 3 - 6 - 9 and 12 months after procedure

• Comorbidities improvement

  7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure

• Quality of life improvement

  3 - 12 - 18 and 24 months after procedure

• Gastro-intestinal quality of life improvement

  3 - 12 - 18 and 24 months after procedure

• Modification in the feeling of satiety

  1 - 3 - 6 - 12 - 18 and 24 months after procedure

Study Arms (1)

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

Interventions

Endoscopic gastric tubulization PROCEDURE

Endoscopic gastric tubulization is performed using the CE marked endoscopic suture device Overstitch (Apollo Endosurgery, Austin, Tx. USA).

Endoscopic gastric tubulization

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

Sponsors & Collaborators

• IHU Strasbourg: lead

Study Sites (1)

Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil

Strasbourg, 67091, France

RECRUITING

Related Publications (5)

• 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.

  PMID: 25380508 BACKGROUND

• 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.

  PMID: 26003549 BACKGROUND

• 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.

  PMID: 26878054 BACKGROUND

• 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.

  PMID: 25380510 BACKGROUND

• 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.

  PMID: 23711556 BACKGROUND

MeSH Terms

Conditions

Obesity, Morbid; Weight Loss

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Silvana Perretta, MD, PhD

  Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil - Strasbourg

  PRINCIPAL INVESTIGATOR

• Michel Vix, MD

  Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil - Strasbourg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Silvana Perretta, MD, PhD

CONTACT

+ 33 3 69 55 05 31; silvana.perretta@ircad.fr

Michel Vix, MD

CONTACT

+ 33 3 69 55 13 03; michel.vix@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2018
• First Posted: June 13, 2018
• Study Start: June 8, 2018
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)