ESG in Obese Adolescents

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Children's Hospital of Philadelphia
Study ID
NCT06914765
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Endoscopic Sleeve Gastroplasty (ESG) Procedure — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Dec 3, 2025
Status verified
Dec 2025
Primary completion
Jan 31, 2028
Completion
Jan 31, 2030

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ESG Intervention

Primary Outcome Measure

Determine whether use of the Apollo Endosurgery ESG System is a safe, well tolerated intervention for weight loss in our study population [ Time Frame: 24 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
The Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-

Find similar trials in Philadelphia, PA

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
The Children's Hospital of Philadelphia· Philadelphia, PA

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