Actively Recruiting

Age: 18Years - 65Years
All Genders
ID03554902

Endoscopic Gastric Tubulization for Morbid Obesity Using Overstitch Endoscopic Suturing Device

Led by IHU Strasbourg · Updated on 2025-05-01

300

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Brief Title

Endoscopic Gastric Tubulization

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients scheduled for an endoscopic gastric tubulization in the Nouvel Hôpital Civil, Strasbourg, France
Not Eligible

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

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)

Long-term Monitoring

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

Trial Site Locations

Total: 1 location

1

Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil

Strasbourg, France, 67091

Actively Recruiting

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Research Team

S

Silvana Perretta, MD, PhD

M

Michel Vix, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Initial experience with endoscopic sleeve gastroplasty: technical success and reproducibility in the bariatric population.

Reem Z Sharaiha, Prashant Kedia, Nikhil Kumta...

https://pubmed.ncbi.nlm.nih.gov/25380510

Endoscopic sleeve gastroplasty: a potential endoscopic alternative to surgical sleeve gastrectomy for treatment of obesity.

Barham K Abu Dayyeh, Elizabeth Rajan, Christopher J Gostout

https://pubmed.ncbi.nlm.nih.gov/23711556