A novel investigational weight-loss device called the TransPyloric Shuttle (TPS) system (BAROnova) was safe and effective in a 12-month phase 3 pivotal trial.  

Results from the nine-site ENDOBesity II study were presented November 14 here at Obesity Week 2018 by Richard Rothstein, MD, the Joseph M. Huber professor and chair of medicine, Geisel School of Medicine, Dartmouth University, Lebanon, New Hampshire.

The device, made of silicone, is delivered endoscopically to the pylorus where it self-positions and alters gastric emptying without changing the patient's anatomy. It is designed to remain in place for a year, after which it is removed, again endoscopically. Both delivery and retrieval procedures are performed as outpatient procedures and take about 15 minutes each, Rothstein said.

The study met both of its co-primary endpoints for total body weight loss compared with sham control and percentage of patients with 5% or more of total body weight loss at 12 months. The rate of a device or procedure-related serious adverse events was lower than that for fluid-filled balloons and just slightly higher than for gas-filled balloons, Rothstein noted.

Asked to comment, Stephen R. Smith, said that it is difficult to compare event rates because the devices have not been studied in head-to-head trials and the method isn't on the market yet. But I said that I categorized this device in the same middle area as swallowable balloons and other weight devices, between medical and surgical obesity treatments.

"We will need some postmarket surveillance to ensure that there is safety [data] for rare events, and for when the device is outside the hands of expert endoscopists," Smith commented. "When you put [devices] into the community setting you often get different results," he said.

Pivotal Trial Met Coprimary Endpoints

The study presented by Rothstein randomized 270 patients with a body mass index of 30 to 40 kg/m2 to TPS (n = 181) or sham device (n = 89), and another 32 patients received open-label TPS for additional safety analysis after a minor modification was made to the device's distal bulb.  Patients were mostly in their mid-40s, were predominantly women, and had a mean BMI of 36 kg/m2.

At 12 months, there was a significant 6.7% difference in total body weight loss between the two groups, averaging 9.5% with the TPS versus 2.8% for the sham device (P < .0001). Results of two intent-to-treat analyses were similar.

The proportion of patients who lost 5% or more of total body weight was 67.0% with TPS versus 59.5% with sham device (P < .0001), and 39.5% versus 14.0% of patients, respectively, lost 10% or more of total body weight (P = .0001).

Cardiometabolic risk factors

Improvements in cardiometabolic risk factors were also seen with the TPS compared with the controls, including reduced blood pressure (P < .05) and increases in insulin resistance and total and LDL-cholesterol (P < .05).

The TPS group also showed significantly higher improvement in the quality of life scores in the areas of physical function, self-esteem, sexual life, and work, Rothstein said, adding that these results will be reported in greater detail in the future.