A prospective, multi-center clinical trial of the Taylor intragastric balloon for the treatment of morbid obesity.

Abstract

This report describes the result of a prospective, multicenter clinical trial of the Taylor intragastric balloon for the treatment of morbid obesity. Sixty patients, who had failed sustained weight loss on prior dietary restriction and behavior modification programs, were enrolled in four clinical centers. The Taylor intragastric balloon, a 550-ml, pear-shaped, liquid-filled, silicone device, was inserted in all patients for a period of 16 wk, and patients were maintained on a dietary restriction and behavior modification program. During the study period, patients experienced a 11.6% decrease in mean weight and an 11.4% decrease in body mass index. Seven balloons deflated spontaneously. Examination of these balloons revealed a manufacturing defect that was subsequently corrected. No further deflations occurred. Effects of the balloons on gastric mucosa were minimal with no gastric erosions or ulcerations noted.