Sleeve gastrectomy or OverStitch endoscopic suturing to restore fullness after weight-loss surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Istituto Auxologico Italiano
  Milan, Italy Recruiting

Study contacts

• Study coordinator: Luisa Gilardini, MD
• Email: l.gilardini@auxologico.it
• Phone: +390261911

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.