Endoscopic Gastric Tubulization

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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.

Eligibility

Primary outcome measure(s)

• Change in weight loss — 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure
  Change in weight loss measured in kilograms.
• Change in excess weight loss — 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure
  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
• Change in body mass index variation — 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure
  Change in body mass index variation measured in kg/m².

Trial sites (1)

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