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

Richard I. Rothstein, Branko Kopjar, George E. Woodman, James M. Swain, Nestor de la Cruz‑Muñoz, Vladimir M. Kushnir, Aurora D. Pryor, Wayne J. English, Elizabeth A. Odstrcil, Shelby Sullivan

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Vol. 26, Issue 1 Techniques and Innovations in Gastrointestinal Endoscopy

Key Takeaways

Patients with the device lost 9.5% of their body weight at one year, more than three times the 2.8% lost after a sham procedure.
Two-thirds of treated patients lost at least 5% of their weight.
Blood pressure and cholesterol improved more with the device.
Serious device- or procedure-related complications occurred in 2.8% of patients, with no deaths.
Dr. de la Cruz-Muñoz was one of the investigators in this multicenter trial.

Abstract/Summary

This randomized, double-blind, sham-controlled multicenter trial evaluated the TransPyloric Shuttle, a silicone device placed in the stomach by endoscopy for one year, in adults with class I or II obesity. Of 270 randomized patients, 181 received the device and 89 a sham procedure; another 32 were treated open-label. At 12 months, total body weight loss was 9.5% with the device versus 2.8% with sham, and 67.0% versus 29.3% of patients lost at least 5% of their weight. Blood pressure, total cholesterol and LDL cholesterol were lower in the treatment group. Device- or procedure-related serious adverse events occurred in 2.8% of patients, and there were no deaths. (ClinicalTrials.gov NCT02518685)

In-Depth Review

Why This Study Was Needed

Many people with a BMI of 30 to 40 want a meaningful, non-surgical option. The TransPyloric Shuttle is a silicone device placed in the stomach through the mouth by endoscopy. It intermittently sits at the outlet of the stomach, slowing emptying so patients feel full sooner and longer, and it is removed endoscopically after a year. Proving that such a device works requires the most rigorous design: a blinded comparison against a sham procedure.

How the Study Was Done

This multicenter, randomized, double-blind, sham-controlled trial (ENDObesity II) enrolled adults with class I or II obesity at centers across the United States, with Dr. de la Cruz-Muñoz among the investigators. Of 270 randomized patients, 181 received the device and 89 a sham endoscopy; 32 more were treated open-label. All received lifestyle counseling, and outcomes were measured at 12 months.

What the Study Found

Total body weight loss at one year was 9.5% with the device versus 2.8% with sham.
67.0% of treated patients lost at least 5% of their weight, compared with 29.3% after sham.
Blood pressure, total cholesterol and LDL cholesterol were lower in the treatment group.
Device- or procedure-related serious adverse events occurred in 2.8% of patients; there were no deaths.
More treated patients withdrew early (22% vs 11%).

What This Means for Patients

Endoscopic devices can deliver meaningful weight loss without surgery for people with moderate obesity, though less than surgery and with a need for good follow-up. Today’s non-surgical menu includes the Allurion balloon, Orbera balloon, endoscopic sleeve gastroplasty and a medical weight loss program with GLP-1 medications. Read the Allurion balloon and ESG vs. sleeve.

Clinical Pearls

The device produced more than three times the weight loss of sham at one year.
Two-thirds of patients reached at least 5% weight loss.
Gastrointestinal side effects and early withdrawals were the main drawbacks.

Strengths and Limitations

A double-blind, sham-controlled design makes this one of the highest-quality trials of an endoscopic weight loss device. Follow-up was limited to the year the device was in place, so durability after removal is not addressed, and early withdrawal was higher in the treatment group.

Expert Commentary

I have taken part in many trials of endoscopic weight loss therapies because patients deserve options between diet and surgery. This trial was rigorously designed, with a true sham control, and it showed real, measurable benefit. The lesson I share with patients is that these devices help most when they are part of a full program.

— Dr. Nestor de la Cruz-Muñoz

Related Research

Randomized Sham-Controlled Trial Evaluating Efficacy and Safety of Endoscopic Gastric Plication for Primary Obesity: The ESSENTIAL Trial

Rothstein RI, Kopjar B, Woodman GE, Swain JM, de la Cruz-Muñoz N, Kushnir VM, Pryor AD, English WJ, Odstrcil EA, Sullivan S. Randomized Double-blind Sham-controlled Trial of a Novel Silicone-filled Endoscopically Placed Device for Weight Loss. Techniques and Innovations in Gastrointestinal Endoscopy. 2024;26(1):21-29. doi:10.1016/j.tige.2023.10.002.