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ESG in Obese Adolescents

NCT06914765 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-12-10

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Michael Manfredi, MD · Children's Hospital of Philadelphia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-03
Primary Completion
2028-01-31
Completion
2030-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06914765 on ClinicalTrials.gov