Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID05777928

Sleeve Gastrectomy and OverStitch17 Endoscopic Suturing System in the Modulation of Perceived Satiety

Led by Istituto Auxologico Italiano · Updated on 2025-10-03

60

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying how perceived satiety, or the feeling of fullness, changes after two types of bariatric surgery in adults with severe obesity. The study focuses on patients who are candidates for Sleeve Gastrectomy or those needing revision surgery with the OverStitch17 Endoscopic Suturing System due to weight regain after prior bariatric surgery. This research explores how surgical changes affect hunger and fullness using a non-invasive test since current data on satiety in patients with gastro-jejunal anastomosis dilation is limited. Participants will undergo either Sleeve Gastrectomy, which involves removing a large part of the stomach to create a smaller, tube-shaped stomach, or a revision surgery using the OverStitch17 Endoscopic Suturing System. The latter is a fully endoscopic method that tightens the enlarged gastro-jejunal connection to reduce complications and improve satiety. Both procedures aim to modify gastric function to influence hunger and fullness. During the study, participants will have their satiety measured using the Water Load Test before surgery and again six months afterward. This test measures how much water a person drinks until feeling pleasantly full, reflecting their subjective satiety. Researchers will monitor changes in satiety to assess the impact of the surgeries. The total monitoring period spans at least six months post-procedure to evaluate sustained effects on hunger and fullness.

CONDITIONS

Brief Title

Bariatric Surgery and Modulation of Perceived Satiety

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Subjects who are eligible for sleeve gastrectomy according to the SICOB criteria
  • Subjects previously undergoing Sleeve Gastrectomy or gastric bypass who have weight regain and are scheduled for revision surgery with the OverStitch17 Endoscopic Suturing System
Not Eligible

You will not qualify if you...

  • None

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surgery and Immediate Post-operative Care

Duration - Day of surgery and subsequent hospital stay

Participants undergo either sleeve gastrectomy or a revision bariatric surgery using the OverStitch™ Endoscopic Suturing System and receive immediate post-operative care.

1 surgery visit and immediate post-operative care

Post-operative Follow-up

Duration - 6 months

Participants are followed after surgery to monitor recovery and outcomes, including satiety evaluations.

Visits at baseline and 6 months after surgery

Trial Site Locations

Total: 1 location

1

Istituto Auxologico Italiano

Milan, Italy, 20145

Actively Recruiting

Loading map...

Research Team

L

Luisa Gilardini, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Similar Trials

Evaluation of Efficiency and Complications of Laparoscopic A...

Bariatric Surgery Candidate

Actively Recruiting

1 location

Bariatric Surgery and Pharmacokinetics Amlodipine: BAR-MEDS ...

Obesity, Morbid

Actively Recruiting

1 location

Bariatric Surgery and Pharmacokinetics of Apixaban: BAR-MEDS...

Obesity, Morbid

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here