Implanted Closed-Loop Gastric Electrical Stimulation (CLGES) System with Sensor-Based Feedback Safely Limits Weight Regain at 24Months.

Abstract

Weight regain following bariatric surgery is not uncommon. Safe, effective weight loss treatment up to 1year has been reported with the closed-loop gastric electrical stimulation (CLGES) system. Continuous recording of eating and activity behavior by onboard sensors is one of the novel features of this closed-loop electrical stimulation therapy, and may provide improved long-term weight maintenance by enhancing aftercare. Four centers participating in a 12-month prospective multicenter randomized study monitored all implanted participants (n = 47) up to 24months after laparoscopic implantation of a CLGES system. Weight loss, safety, quality of life (QOL), and cardiac risk factors were analyzed. Weight regain was limited in the 35 (74%) participants remaining enrolled at 24months. Mean percent total body weight loss (%TBWL) changed by only 1.5% between 12 and 24months, reported at 14.8% (95% CI 12.3 to 17.3) and 13.3% (95% CI 10.7 to 15.8), respectively. The only serious device-/procedure-related adverse events were two elective system replacements due to lead failure in the first 12months, while improvements in QOL and cardiovascular risk factors were stable thru 24months. During the 24month follow-up, CLGES was shown to limit weight regain with strong safety outcomes, including no serious adverse events in the second year. We hypothesize that CLGES and objective sensor-based behavior data combined to produce behavior change. The study supports CLGES as a safe obesity treatment with potential for long-term health benefits. ClinicalTrials.gov identifier: NCT01448785.