Clinical trial

Endoscopic Gastric Tubulization

Recruiting now · Not applicable · 1 countries · Registry ID NCT03554902

Recruiting nowNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionMorbid Obesity

Full registry criteria

Inclusion Criteria: * Patients scheduled for an endoscopic gastric tubulization in the Nouvel Hôpital Civil, Strasbourg, France

Treatments and study arms

Endoscopic gastric tubulization

Procedure

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

Primary outcomes

Change in weight loss7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure

Change in weight loss measured in kilograms.

Change in excess weight loss7 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 variation7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure

Change in body mass index variation measured in kg/m².

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil🇫🇷 Strasbourg, France

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Silvana Perretta, MD, PhDContact

Email · Call + 33 3 69 55 05 31

Michel Vix, MDContact

Email · Call +33 3 69 55 13 09

Silvana Perretta, MD, PhDPrincipal Investigator