An observational study in Morbid Obesity, sponsored by IHU Strasbourg. Recruiting at 1 site in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-05-01.
Sponsored by IHU Strasbourg · Observational
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.
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.
941 studies on the registry are indexed under Obesity, Morbid; 163 are open to participants now.
This study's planned enrollment of 300 is above the median of 80 across 311 observational studies indexed under Obesity, Morbid.
Browse Obesity, Morbid studies →IHU Strasbourg is the lead sponsor of 44 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients over 18 years old requiring a treatment for morbid obesity.
Inclusion Criteria:
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).
Change in weight loss
Change in weight loss measured in kilograms.
Time frame: 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
Time frame: 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.
Time frame: 7 days, 1 - 3 - 6 - 9 - 12 - 18 and 24 months after procedure
Number of patients with procedure-related adverse event
Number of patients with procedure-related adverse event within 12 months after procedure.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 - 3 - 6 - 12 - 18 and 24 months after procedure
Upper GI tract radiologic evaluation
Upper GI control series.
Time frame: 1 day, 6 - 12 and 24 months after procedure
Upper GI tract endoscopic evaluation
Upper GI control gastroscopy.
Time frame: 6 - 12 and 24 months after procedure
Procedure duration
Time required to perform the endoscopic gastric tubulization.
Time frame: At time of procedure
Number of stitches in place
Number of stitches put in place during the endoscopic gastric tubulization.
Time frame: At time of procedure
Plan to share: No
Started Jun 2018 (actual). Primary completion is estimated for Jun 2028, 120 months after the start.
Of 137 non-industry observational studies under Obesity, Morbid, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 132. This study's planned 120 months is above that.
Counting every sponsor, half of 138 studies reached it within 46 months; a quarter within 16 and three quarters within 132.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
IHU Strasbourg