Transoral gastric volume reduction as intervention for weight management: 12-month follow-up of TRIM trial

Background: The aim of the present pilot study was to evaluate the safety and weight loss efficacy of endoscopic transoral gastric volume reduction using an endoscopic suturing system. Methods: Patients with a body mass index (BMI) of 30-45 kg/m(2) were enrolled in the present institutional review board-approved study. Anterior to posterior gastric plications were placed in the gastric fundus and body using the suturing device. The endpoints were procedure time, adverse events, weight loss, and endoscopic findings at 1, 6, and 12 months after the procedure. The nominal P values are presented. Results: A total of 18 patients underwent the procedure (9 at each site). The mean age and BMI was 40 years and 38 kg/m(2), respectively. The average number of plications placed per patient was 6, and the mean procedure time was 2.1 hours (range 1.5-2.8). At 12 months of follow-up (n = 14), decreases in the mean weight (-11.0 +/- 10.0 kg, P = .0006), mean BMI (-4.0 +/- 3.5 kg/m(2), P =.0006), and mean waist circumference (-12.6 +/- 9.5 cm, P = .0004) were observed. The mean excess weight loss at 12 months was 27.7% +/- 21.9%. The proportion of patients with an EWL of >= 20% or >= 30% was 57% and 50%, respectively. The mean systolic and diastolic blood pressure decreased by 15.2 mm Hg (P = .0012) and 9.7 mm Hg (P = .0051), respectively. No device- or procedure-related serious adverse events. Endoscopy at 12 months of follow-up showed partial or complete release of plications in 13 patients. Conclusion: Transoral gastric volume reduction procedure using the RESTORe Suturing System device proved to be safe and well tolerated. Procedural technical success was achieved for all subjects. Modest decreases in weight, BMI, and waist circumference were observed, as was a decline in the frequency of hypertension. Despite some overall positive clinical findings, the plications were not durable, and the effects of the procedure varied widely among the study participants. Additional research is needed to provide a more reproducible and durable effect. (Surg Obes Relat Dis 2012;8:296-304.) (C) 2012 American Society for Metabolic and Bariatric Surgery. All rights reserved.