Intragastric Balloon in Obese Adolescents With Comorbidities

NCT03233048 | Completed Results DMC FDA Device

• 1 other identifier: 15-009191
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The reason we are doing this research is to get information about the ORBERA™ Intragastric Balloon to learn if it is safe and if it works. We want to learn if older teenagers who are overweight will lose weight and if their other medical problems will get better. ORBERA™ is a special balloon approved by the FDA for overweight adults, and we would like to try using it for overweight teenagers.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Achieving Greater Than or Equal to 10% Total Body Weight Loss

  Weight loss will be measured by change in weight divided by baseline weight.

  up to 1 year

Secondary Outcomes (10)

• Change in Alanine Aminotransferase (ALT)

  Baseline, end of study (approximately 1 year)

• Change in Aspartate Aminotransferase (AST)

  Baseline, end of study (approximately 1 year)

• Change in Fasting Insulin

  Baseline, end of study (approximately 1 year)

• Change in Hemoglobin A1c (HgA1c)

  Baseline, end of study (approximately 1 year)

• Change in High-density Lipoprotein (HDL)

  Baseline, end of study (approximately 1 year)

Study Arms (1)

ORBERA™ Intragastric Balloon

EXPERIMENTAL

Participants will have the ORBERA™ Intragastric Balloon inserted for 6 months. In addition, participants will have ongoing visits with a physician, dietitian, and psychologist before the balloon is inserted, while its in place, and for 6 months after the balloon is removed, for a total of approximately 1 year.

Device: ORBERA™ Intragastric Balloon

Interventions

ORBERA™ Intragastric Balloon DEVICE

The balloon will be inserted into the stomach and inflated, and will remain in place for 6 months, after which the device will be removed.

ORBERA™ Intragastric Balloon

Eligibility Criteria

• Age: 14 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• BMI\>35 kilogram per square meter (kg/m2) with one of the following severe comorbidities, both for at least 2 years:
• Type 2 diabetes mellitus
• Moderate-to-severe sleep apnea
• Pseudotumor cerebri
• Nonalcoholic Steatohepatitis (NASH) based on fatty infiltration of the liver with transaminitis that cannot be explained by other liver disease
• Or,
• BMI\>40 kilogram per square meter (kg/m2) with two or more of the following mild comorbidities, all for at least 2 years:
• Hypertension
• Dyslipidemia
• Mild obstructive sleep apnea
• Chronic venous insufficiency
• Panniculitis
• Urinary incontinence
• Nonalcoholic Steatohepatitis (NASH)
• Gastroesophageal reflux disease (GERD)

You may not qualify if:

• Subjects will be excluded if:
• they are pregnant or breastfeeding, or
• there is any other disease, physical examination finding, or clinical laboratory result that provides a reasonable suspicion of a disease or condition that contraindicates the use of the investigational device or that may affect the interpretation of the results or render the subject at high risk for treatment complications, or
• there is alcohol, tobacco, or substance use by the subject, or
• in the opinion of the principal investigator (PI) and/or co-investigators, subject or parent/guardian may be non-compliant with study schedules or procedures, or
• there are any endoscopic contraindications, including large hiatal hernia (≥ 2 cm), esophagitis of any degree, erosive gastritis, or ulceration of the stomach or duodenum, or
• Helicobacter pylori (H. pylori) is detected via a fecal antigen study prior to initial endoscopic assessment (sensitivity \> 96.8%); once treated, a repeat fecal antigen must be performed to document eradication prior to the first endoscopic approach for balloon placement, or
• they have hypertension stage II \> 99th percentile, unless they had a complete workup to exclude secondary etiologies other than being overweight, or
• Gastroesophageal reflux disease (GERD) subjects are on more than one medication or have a history of erosive esophagitis due to gastroesophageal reflux disease (GERD), or
• they have dyslipidemia, if part of hereditary metabolic syndrome or genetic disorder, or
• they have any gastrointestinal disease that can result in stomach ulcerations, such as Crohn's disease, celiac disease, eosinophilic esophagitis, acute or chronic pancreatitis or gastrinoma, or
• they have any endocrine disorders that affect metabolic status of the subjects, such as hypo/hyperthyroidism, type 1 diabetes, Cushing's disease, or adrenal insufficiency, as documented in the electronic medical record (EMR) through an evaluation by the pediatric endocrinologist who will order additional testing if needed, or
• they have prior gastrointestinal surgery with sequelae, i.e. obstruction, and/or adhesive peritonitis or known abdominal adhesions and/or history of abdominal and/or pelvic surgery which may cause adhesions (except one of the following: caesarean section, diagnostic laparoscopy, laparoscopic appendectomy, laparoscopic cholecystectomy performed 12 or more months prior to balloon implantation), or
• they have prior open or laparoscopic bariatric surgery, or
• they have prior surgery of any kind on the esophagus, stomach or any type of hiatal hernia surgery, or

Sponsors & Collaborators

• Imad Absah: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Imad Absah
• Organization: Mayo Clinic

absah.imad@mayo.edu

507-266-0114

Study Officials

• Imad Absah, M.D.

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: July 26, 2017
• First Posted: July 28, 2017
• Study Start: October 26, 2017
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: May 3, 2022
• Results First Posted: May 3, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)