Study of AspireAssist Aspiration Therapy System in obesity published in American Journal of Gastroenterology- Aspire Bariatrics
Aspire Bariatrics announced that the results of the PATHWAY study of AspireAssist, a 171-subject, multicenter randomized control trial in the US, was published in the American Journal of Gastroenterology. The AspireAssist, an endoscopic alternative to weight loss surgery, is indicated for adults with a BMI of 35 to 55. The AspireAssist received premarket approval from the Food & Drug Administration in June 2016 and is now available commercially in the US, Europe, Australia, and New Zealand.
Although the study was not sized to show significant improvement in cardiometabolic parameters, clinically significant improvement in the treatment group was seen in HbA1C (-0.36% relative to 5.7% baseline), triglycerides (?9.9%, P =0.02), and high-density lipoprotein cholesterol (+8.1%, P =0.0001), at week 52 compared with baseline. There was no evidence of patients in the treatment group developing adverse eating behaviors.
See: "Percutaneous Gastrostomy Device for the Treatment of Class II and Class III Obesity: Results of a Randomized Controlled Trial" Christopher C Thompson et al. Am J Gastroenterol advance online publication 6 December 2016; doi: 10.1038/ajg.2016.500