Obesity, Childhood
Conditions
Brief summary
In this study, the investigators assess the safety and efficacy of endoscopic sleeve gastroplasty in adolescents with obesity.
Detailed description
Endoscopic bariatric therapy (EBT) is an emerging, rapidly evolving field that aims to serve as a middle ground between safe, albeit poorly effective medical weight loss strategies and drastic but effective bariatric surgery. Endoscopic sleeve gastroplasty (ESG) is a procedure that restricts the stomach to a sleeve-like configuration by utilizing full-thickness sutures that plicate the greater curvature of the stomach. Emerging data from adult populations shows an acceptable safety, tolerability and efficacy profile. Based on analysis that confirmed the safety and efficacy of ESG in adult patients who undergo the procedure under a standardized protocol and clinical care pathway, the investigators planned to study its effects on adolescents in a specialized center that offers surgical, endoscopic, and medical management of obesity under a standardized protocol and care pathway.
Interventions
PROCEDUREEndoscopic Sleeve Gastroplasty
Endoscopic full-thickness suture system to plicate the greater curvature of the stomach
Sponsors
New You Medical Center
King Saud University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 21 Years
Healthy volunteers
Yes
Inclusion criteria
* BMI that is \>120% of the 95th percentile for age and gender * Written informed assent/consent, with concomitant parental consent for patients aged ≤17 years
Exclusion criteria
* Age \<10 years * Age \>21 years * Presence of large hiatal hernia * Previous gastric surgery * Cognitive impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight Loss | One year | % total weight loss |
| Adverse events | One year | Adverse events, including hospitalization, or unplanned intervention |
Countries
Saudi Arabia
Outcome results
None listed