A prospective, multi-center clinical trial of the Taylor intragastric balloon for the treatment of morbid obesity
Marshall, J.B.; Schreiber, H.; Kolozsi, W.; Vasudeva, R.; Bacon, B.R.; McCullough, A.J.; Holt, S.
American Journal of Gastroenterology 85(7): 833-837
1990
ISSN/ISBN: 0002-9270 PMID: 2196784 Document Number: 352461
60 patients who had failed to sustain weight loss on prior dietary restriction and behaviour modification programmes were enrolled in 4 clinical centres. The Taylor intragastric balloon, a 550-ml, pear-shaped, liquid-filled, silicone device, was inserted in all patients for a period of 16 weeks, and patients were maintained on a dietary restriction and behaviour modification programme. During the study period, patients experienced an 11.6% decrease in mean weight and an 11.4% decrease in body mass index. 7 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.