NCT06914765

ESG in Obese Adolescents

A Pilot Study Evaluating the Safety and Efficacy of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adolescents

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Children's Hospital of Philadelphia · Academic / Other
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obese Adolescents
• Obesity, Morbid
• Obesity/Therapy

Interventions

Type	Name	Description
DEVICE	Endoscopic Sleeve Gastroplasty (ESG) Procedure	The ESG procedure will be performed under general anesthesia monitored by an anesthesiologist. The device that will be used is called the Apollo Endosurgery ESG System, which is the only FDA approved device for the reduction of stomach volume through endoscopic sleeve gastroplasty for adult patients with obesity. This device works by being attached to a standard upper endoscope and is inserted through the mouth and goes into the stomach. When in the stomach, the back and front wall of the stomach will be stitched together to reduce the size of the stomach and help decrease the amount of food a patient can eat and drink at one time before feeling full.

Timeline

• Start date: 2025-12-03
• Primary completion: 2028-01-01
• Completion: 2030-01-01
• First posted: 2025-04-06
• Last updated: 2025-12-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study