Clinical Trial

ESG in Obese Adolescents

Enrolling by Invitation
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Summary
The primary goal of this pilot study is to learn if the use of the Apollo Endosurgery ESG System is a safe, well tolerated intervention for weight loss in adolescents with obesity. Secondary outcomes will evaluate the effectiveness of Endoscopic Sleeve Gastroplasty (ESG) in long-term reduction of weight, improvements in obesity-related co-morbidities and improvements in quality of life. Participants will: * Have their stomach volume reduced with the ESG procedure (study intervention), rather than with a bariatric surgery, under general anesthesia * Undergo pregnancy testing (female participants only) * Be admitted overnight to the hospital for recovery and monitoring following the ESG procedure * Have a physical examination performed at study follow-up visits * Participate in surveys about any side effects from the procedure and about quality of life * Follow-up with the study team. * Participants will still be seen in the multidisciplinary Bariatrics Clinic team consisting of an obesity medicine doctor, registered dietician, physical activity specialist, and psychologist as part of normal standard of care.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-03-31; most recent amendment 2025-12-03.
Status change: Not Yet Recruiting → Enrolling by Invitation 2025-12-03
Trial Details
NCT Number NCT06914765
Lead Sponsor Children's Hospital of Philadelphia
Collaborators: Boston Scientific Corporation
Conditions Obese Adolescents, Obesity, Morbid, Obesity/Therapy
Enrollment 10 participants
Start Date 2025-12-03
Primary Completion 2028-01 (estimated)
Study Completion 2030-01 (estimated)
Updated on ClinicalTrials.gov 2025-12-10