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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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.
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Determine whether use of the Apollo Endosurgery ESG System is a safe, well tolerated intervention for weight loss in our study population
Number of procedure related adverse events will be collected. Severity of adverse events will be defined using the Clavien-Dindo Classification of Surgical Complications.
Time frame: 24 months
Evaluate the effectiveness of ESG in long-term reduction of weight (BMI)
The primary parameter for assessing this objective will be a function of the percent change in BMI.
Time frame: 24 months
Evaluate the effectiveness of ESG in long-term reduction of weight (waist circumference)
Change in waist circumference, measured in centimeters.
Time frame: 24 months
Evaluate the effectiveness of ESG in long-term reduction of weight (obesity class)
Number of subjects who shift in class of obesity (class 3, class 2, and class 1).
Time frame: 24 months
Evaluate the impact of weight loss from ESG procedure on Type 2 Diabetes (with unchanged medication use)
Number of patients who show improvement in glycemic control parameters (fasting glucose, fasting insulin and HbA1c)
Time frame: 24 months
Evaluate the impact of weight loss from ESG procedure on Type 2 Diabetes (with decreased medication use)
Number of patients who show improvement in glycemic control parameters (fasting glucose, fasting insulin and HbA1c )
Time frame: 24 months
Evaluate the impact of weight loss from ESG procedure on Type 2 Diabetes (with medication discontinuation)
Number of patients who show improvement in glycemic control parameters (fasting glucose, fasting insulin and HbA1c)
Time frame: 24 months
Evaluate the impact of weight loss on obesity-related co-morbidities (reducing hypertension medication)
Number of subjects with a reduction in anti-hypertensive medication intake with no increase in blood pressure
Time frame: 24 months
Evaluate the impact of weight loss on obesity-related co-morbidities (reducing blood pressure)
Number of subjects with a reduction in blood pressure of 10/5mmHg with no increase in medication
Time frame: 24 months
Evaluate the impact of weight loss on obesity-related co-morbidities (stage of hypertension)
Number of subjects who show reduction in stage of hypertension (examples include Stage 2 Hypertension to Stage 1 Hypertension or Stage 1 Hypertension to no hypertension)
Time frame: 24 months
Evaluate the impact of weight loss on obesity-related co-morbidities (Dyslipidemia)
Number of subjects with decrease in low-density lipoprotein (LDL) by 10 mg/dL (with no increase in medication)
Time frame: 24 months
Evaluate the impact of weight loss on obesity-related co-morbidities (Dyslipidemia medications)
Number of subjects with reduction in medication intake with no adverse change in dyslipidemia indexes (LDL, TCL/HDL cholesterol ratio)
Time frame: 24 months
Evaluate the impact of weight loss on obesity-related co-morbidities (triglycerides)
Number of subjects with a decrease in fasting triglyceride to \<150 mg/dL
Time frame: 24 months
Evaluate changes in hunger and satiety
Changes will be measured using a 2-item hunger-satiety questionnaire. This is a 2 item, self-report, measure that will assesses the subjects' hunger and fullness before and post-procedure.
Time frame: 24-months
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