Background: Intragastric balloons have been used to bridge the obesity treatment gap with the benefits of being minimally invasive but still required endoscopy. The Elipse intragastric balloon (EIGB) is a swallowable balloon that is spontaneously excreted through a natural orifice at approximately 16 weeks. Several concerns exist, including the treatment efficacy and risk of bowel obstruction. Our meta-analysis aimed to evaluate the efficacy and safety of EIGB.
Methods: A literature search was performed from several databases from database inception to November 2019. Eligible studies must report percent total weight loss (%TWL) after completion of treatment and adverse events. The pooled means and proportions of our data were analyzed using random effects model, generic inverse variance method.
Results: Six studies involving 2013 unique patients met our eligibility criteria and were included. The mean baseline BMI ranged from 30.6 to 36.2. The pooled early removal rate was 2.3% (95% CI, 1.1-3.5%; I2 31%). The pooled %TWL after completion of treatment (4-6 months) was 12.8% (95% CI, 11.6-13.9%; I2 83%) and at 12 months was 10.9% (95% CI, 5.0-16.9%, I2 98%). For serious adverse events, three patients had small bowel obstruction, and one patient had gastric perforation requiring surgery. Early expulsion by emesis and early deflation were seen in 3 and 9 patients, respectively.
Conclusions: This meta-analysis demonstrates that EIGB is a safe device offering an effective weight loss that warrants further studies for its long-term weight loss outcomes. Severe adverse events are rare, and the rate of early removal is low.
Keywords: Elipse Intragastric Balloon; Gastric balloon; Procedureless Gastric Balloon.