*7.1.3.1 AspireAssist®*

*Weight Management*

(non-exhaustive list).

loss [8, 13].

*7.1.2.3 TransPyloric Shuttle*

subject (0.3%), a case of peptic ulcer disease.

loss in obesity with BMI between 30 and 40 kg/m<sup>2</sup>

300 subjects (89.3%). Device- or procedure-related SAEs were observed in one

Overall, Obalon Balloon System is relatively safe and has a modest effectiveness. The device was approved by the FDA in September 2016. It is indicated for weight

recommendations, in subjects who failed to respond to diet, exercise, and behavior change. It is contraindicated in several conditions including pregnancy, non-adult subjects, prior bariatric surgery, inflammatory diseases of the gastrointestinal tract, gastric diseases, and eating disorders (non-exhaustive list). Complications include balloon migration, intestinal obstruction, gastric ulcer, and gastric perforation

TransPyloric Shuttle (BAROnova, Inc.) is a device placed endoscopically in the stomach (**Figure 4**). It is not strictly a balloon but functions like a balloon. It has two asymmetrical bulbs made of silicone connected by a flexible catheter. The procedure is minimally invasive and can be performed in an outpatient setting. The shuttle is removed endoscopically after 12 months. By creating intermittent obstruction to gastric outflow that delays gastric emptying, TransPyloric Shuttle causes early satiety and a decrease in food intake with subsequent weight

In the pivotal study, 270 subjects (252 females, 18 males, mean BMI = 36.6 kg/m2

were randomized into TransPyloric Shuttle (n = 181) or control (sham endoscopic procedure, n = 89) arms for 12 months. The TransPyloric Shuttle was successfully placed in 171 subjects. The study also included an additional 32 open-label subjects who received TransPyloric Shuttle. All subjects were given lifestyle recommendations. The co-primary effectiveness endpoints, assessed in the per protocol population at Month 12, were a significantly greater weight loss in TransPyloric Shuttle arm compared to control arm and the responder rate at 5% weight loss in TransPyloric Shuttle arm. At Month 12, the weight losses were 9.5 and 2.8% in TransPyloric Shuttle and control arms, respectively, and the responder rate at 5% weight loss in TransPyloric Shuttle arm was 66.8%. The study met both co-primary effectiveness endpoints. Most device-related AEs were of gastrointestinal origin (mainly nausea/ vomiting, abdominal pain, and dyspepsia, mild or moderate in the majority of

*TransPyloric Shuttle (BAROnova, Inc.—Picture downloaded from the internet).*

, in conjunction with lifestyle

)

**246**

**Figure 4.**

AspireAssist® (Aspire Bariatrics, Inc.) is a device attached to a percutaneous endoscopic gastrostomy tube implanted endoscopically (**Figure 5**). It allows the aspiration of gastric contents 20–30 minutes after each major meal (a meal containing more than 200 calories). Thorough chewing of food is required to facilitate aspiration with the 6-mm-diameter tube. The procedure is minimally invasive and can be performed in an outpatient setting. The device is removed when the desired body weight is reached. By allowing the removal of approximately 30% of ingested calories over 5–10 minutes, AspireAssist® causes decreased absorption of gastrointestinal nutrients with subsequent weight loss [8, 11–14].

In the pivotal study, 171 subjects (149 females, 22 males, mean BMI = 41.6 kg/ m2 ) were randomized into AspireAssist® (n = 111) or control (no intragastric intervention, n = 60) arms for 12 months. All subjects were given lifestyle recommendations. The co-primary effectiveness endpoints, assessed in the mITT population at Month 12, were a significantly greater excess weight loss in AspireAssist® arm compared to control arm (super-superiority) and the responder rate at 25% excess weight loss in AspireAssist® arm. At Month 12, the excess weight losses were 31.5 and 9.8% in AspireAssist® and control arms, respectively, and the responder rate at 25% excess weight loss in AspireAssist® arm was 56.8%. The study met the first co-primary effectiveness endpoint but not the second co-primary effectiveness endpoint. At Month 12, the weight losses were 12.1 and 3.6% in AspireAssist® and

**Figure 5.** *AspireAssist® (Aspire Bariatrics, Inc.—Picture downloaded from the internet).*

control arms, respectively. Device- or procedure-related AEs were observed in 93 subjects (83.8%, mainly peristomal granulation tissue, abdominal pain, and nausea/ vomiting, mild in the majority of cases). Device- or procedure-related SAEs were observed in four subjects (3.6%), including peritonitis but no death.

Overall, AspireAssist® is relatively safe and has a strong effectiveness. The device was approved by the FDA in June 2016. It is indicated for weight loss in obesity with BMI between 35 and 55 kg/m<sup>2</sup> , in conjunction with lifestyle recommendations, in subjects who failed to respond to non-surgical weight-loss therapy. It is contraindicated in several conditions including pregnancy, non-adult subjects, upper gastrointestinal bleeding conditions, chronic abdominal pain, severe cardiopulmonary diseases, and eating disorders (non-exhaustive list). Complications include skin irritation, infection, and electrolyte abnormalities (non-exhaustive list).
