Endoscopic sleeve gastroplasty for the treatment of obesity.
Gontrand Lopez-Nava, Manoel P Galvão, Immacula da Bautista-Castaño...
https://pubmed.ncbi.nlm.nih.gov/25380508Actively Recruiting
Led by IHU Strasbourg · Updated on 2025-05-01
300
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are collecting data on adult patients with morbid obesity who undergo endoscopic gastric tubulization, a less invasive alternative to bariatric surgery. This observational study aims to evaluate weight loss, improvements in quality of life, and reductions in obesity-related health problems over two years after the procedure. The study also seeks to assess the reproducibility and durability of this technique. The treatment involves using the CE marked Overstitch endoscopic suture device to reduce stomach size by merging tissues without incisions. This gastric restriction method is designed to mimic the effects of traditional surgical procedures but with fewer risks and is reversible, allowing for future surgical or endoscopic interventions if needed. The procedure has been standard practice at the Digestive Surgery Department of the Nouvel Hôpital Civil since October 2016. Participants are followed from their last visit before the procedure through two years after treatment. Researchers will monitor changes in weight, excess weight loss, and body mass index at multiple time points up to 24 months. Additional assessments include procedure-related adverse events, improvements in comorbidities, quality of life, gastrointestinal health, satiety, and evaluations of the upper gastrointestinal tract through radiologic and endoscopic exams. The study also records procedure duration and the number of stitches used.
CONDITIONS
Endoscopic Gastric Tubulization
You may qualify if you...
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At time of procedure
Participants undergo endoscopic gastric tubulization using an endoscopic suture device to reduce stomach size without incisions.
1 procedure visit (in-person)
Duration - Up to 2 years after procedure
Participants are monitored for weight loss, quality of life, comorbidities improvement, and procedure safety over 2 years following the procedure.
Visits at 7 days, 1, 3, 6, 9, 12, 18, and 24 months after procedure
Total: 1 location
1
Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil
Strasbourg, France, 67091
Actively Recruiting
S
Silvana Perretta, MD, PhD
M
Michel Vix, MD
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Gontrand Lopez-Nava, Manoel P Galvão, Immacula da Bautista-Castaño...
https://pubmed.ncbi.nlm.nih.gov/25380508G Lopez-Nava, M P Galvão, I Bautista-Castaño...
https://pubmed.ncbi.nlm.nih.gov/26003549G Lopez-Nava, M Galvao, I Bautista-Castaño...
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https://pubmed.ncbi.nlm.nih.gov/23711556