Randomized Double-blind Sham-controlled Trial of a Novel Silicone-filled Endoscopically Placed Device for Weight Loss

• Published in: Techniques and innovations in gastrointestinal endoscopy 2024, Vol.26 (1), p.21-29
• Main Authors: Rothstein, Richard I., Kopjar, Branko, Woodman, George E., Swain, James M., Cruz-Muñoz, Nestor de la, Kushnir, Vladimir M., Pryor, Auora D., English, Wayne J., Odstrcil, Elizabeth A., Sullivan, Shelby
• Format: Article
• Language: English
• Subjects: endoscopic; intragastric; obesity; silicone; weight loss
• ISSN: 2590-0307; 2590-0307
• DOI: 10.1016/j.tige.2023.10.002

While obesity affects over 40% of adults in the United States and is a driver of preventable chronic diseases and healthcare costs, most patients are left untreated. This was a randomized, double-blind, sham-controlled trial to investigate the safety and efficacy of a novel, endoscopically placed intragastric device for weight reduction, the TransPyloric Shuttle® (TPS), implanted for one year in 270 patients with Class I and II obesity. An additional 32 treatment patients were enrolled in an Open-Label group. The co-primary efficacy endpoints were percent total body weight loss (%TBWL) in Treatment group compared with Sham group and a proportion of treatment patients achieving ≥ 5% TBWL at 12 months. The mean %TBWL at 12 months was 9.5% (95% C.I., 8.2 to 10.8) in the Treatment group (n=181) compared to 2.8% (95% C.I., 1.1 to 4.5) in the Sham group (n=89). In the Treatment group, 67.0% (95% C.I., 59.3 to 74.4) of patients achieved ≥ 5% TBWL compared to 29.3% (95% C.I., 19.3% to 39.4%) in the Sham group. Patients in the Treatment group achieved lower blood pressure, total cholesterol, and low-density lipoprotein cholesterol compared with the Sham group. Early withdrawals occurred in 22% and 11% patients in the Treatment and Sham groups, respectively. Device or procedure related serious adverse events occurred in 6 patients (2.8%) and no deaths occurred. Treatment with a novel endoscopically placed intragastric device resulted in meaningful weight loss and improvement in cardiometabolic outcomes in patients with Class I and II obesity. (ClinicalTrials.gov number NCT02518685.)