Abstract
PURPOSE: Medical devices benefit patients living with overweight or obesity, but studies in the adolescent population are lacking. The goal of this study was to collect information on the performance and safety of a swallowable intragastric balloon program (SGBP) in adolescent patients. MATERIALS AND METHODS: Data were collected retrospectively on patients aged 15 to 17 years with body mass index (BMI) ≥ 27 kg/m(2) who received the swallowable intragastric balloon (SGB) and associated lifestyle and nutritional change program. Patients had not responded to previous dietary and behavioral modification weight loss treatments and elected to undergo SGBP. The SGB was swallowed and filled with 550 mL of distilled water in an outpatient setting, and a multidisciplinary team delivered a lifestyle/nutritional change program. Mean % total body weight loss (%TBWL) was calculated for each patient compared with baseline. RESULTS: A total of 91 patients, 69 (75.8%) female and 22 (24.2%) male, underwent SGBP and completed follow-up through SGB passage at 4 months. Baseline mean ± SD age, weight, and BMI were 16.4 ± 0.77, 99.70 ± 21.33 kg, and 35.60 ± 5.59 kg/m(2), respectively. After 4 months, mean weight and BMI were 86.37 ± 18.83 kg and 30.86 ± 5.16 kg/m(2) respectively; %TBWL was 13.05 ± 7.64 (1-sided t-test, p < 0.0001). Most (80, 87.9%) reported no adverse events; 11/91 (12.1%) experienced an adverse event. Of these, 9/91 (9.9%) experienced nausea and/or vomiting; 1/91 (1.1%) reported abdominal pain only; 1/91 (1.1%) reported flatulence only. There were no serious adverse events or premature device removals. CONCLUSION: The SGBP provides safe and effective short-term weight loss in adolescents living with overweight and obesity.