Endoscopic Sleeve Gastroplasty for Obesity

Overseen By Andrea Tou, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital of Philadelphia

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Michael Manfredi, MD

Principal Investigator

Children's Hospital of Philadelphia

Are You a Good Fit for This Trial?

This trial is for obese adolescents aged 12-17 who have tried supervised diets and exercise programs. They must be significantly overweight according to CDC growth curves, possibly with related health issues like diabetes or sleep apnea. Girls can't be pregnant and must agree not to get pregnant during the study.

Inclusion Criteria

My obesity is not due to a genetic condition like Prader-Willi syndrome.

I am between 12 and 17 years old.

I regularly attend a weight loss program and follow its guidelines.

What Are the Treatments Tested in This Trial?

Interventions

• Endoscopic Sleeve Gastroplasty (ESG) Procedure

Trial Overview The trial tests the Apollo Endosurgery ESG System, a non-surgical procedure that reduces stomach volume under general anesthesia. It aims to see if this method is safe for weight loss in teens and how it affects their long-term health and quality of life.

How Is the Trial Designed?

Group I: ESG Intervention Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials

749

Recruited

11,400,000+

Boston Scientific Corporation

Industry Sponsor

Trials

758

Recruited

867,000+

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology