Actively Recruiting
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
Eligibility Criteria
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
You will not qualify if you...
- None
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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
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
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
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