NCT03554902

Endoscopic Gastric Tubulization

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: IHU Strasbourg · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Morbid Obesity

Interventions

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

Timeline

• Start date: 2018-06-08
• Primary completion: 2028-06-01
• Completion: 2028-06-01
• First posted: 2018-06-13
• Last updated: 2025-05-01

Locations

1 site across 1 country: France