Sleeve gastrectomy or OverStitch endoscopic suturing to restore fullness after weight-loss surgery
Sleeve Gastrectomy and OverStitch™ Endoscopic Suturing System in the Modulation of Perceived Satiety
NA · Istituto Auxologico Italiano · NCT05777928
This study will test whether sleeve gastrectomy or endoscopic OverStitch suturing helps people with severe obesity or those with post-bariatric weight regain feel full with smaller meals.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Istituto Auxologico Italiano (other) |
| Locations | 1 site (Milan) |
| Trial ID | NCT05777928 on ClinicalTrials.gov |
What this trial studies
This interventional study enrolls patients eligible for primary sleeve gastrectomy and patients who previously had sleeve gastrectomy or gastric bypass and now have weight regain. Participants will receive either sleeve gastrectomy or endoscopic revision using the OverStitch™ Endoscopic Suturing System as clinically indicated. Investigators will track changes in perceived hunger and satiety, portion sizes, and weight over follow-up visits using standardized questionnaires and clinical measurements. The goal is to link anatomical correction with changes in eating behavior and satiety signals.
Who should consider this trial
Good fit: Ideal candidates are people eligible for sleeve gastrectomy per SICOB criteria or patients who previously had sleeve gastrectomy or gastric bypass and are scheduled for endoscopic revision with OverStitch because of weight regain.
Not a fit: Patients whose weight regain is driven primarily by non-anatomical factors like persistent unhealthy eating habits, low physical activity, or hormonal disorders may not receive benefit from the suturing procedure.
Why it matters
Potential benefit: If successful, the procedure could restore a stronger feeling of fullness, reduce portion sizes, and help prevent or reverse weight regain.
How similar studies have performed: Endoscopic suturing with devices like OverStitch has been used in other centers to reduce stoma or pouch size and some reports show improved satiety and weight outcomes, but the overall evidence base is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * subjects who are eligible for sleeve gastrectomy according to the SICOB criteria * subjects, previously undergoing Sleeve Gastrectomy or gastric bypass, who, for weight regain, have been scheduled for revision surgery with the OverStitch™ Endoscopic Suturing System Exclusion Criteria: * none
Where this trial is running
Milan
- Istituto Auxologico Italiano — Milan, Italy (RECRUITING)
Study contacts
- Study coordinator: Luisa Gilardini, MD
- Email: l.gilardini@auxologico.it
- Phone: +390261911
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Obesity, Morbid, obesity, satiety, Sleeve gastrectomy ,OverStitch