Percutaneous Gastrostomy Device for the Treatment of Class II and Class III Obesity: Results of a Randomized Controlled Trial

Abstract

Objectives:The AspireAssist System (AspireAssist) is an endoscopic weight loss device that is comprised of an endoscopically placed percutaneous gastrostomy tube and an external device to facilitate drainage of about 30% of the calories consumed in a meal, in conjunction with lifestyle (diet and exercise) counseling.Methods:In this 52-week clinical trial, 207 participants with a body-mass index (BMI) of 35.0–55.0 kg/m2 were randomly assigned in a 2:1 ratio to treatment with AspireAssist plus Lifestyle Counseling (n=137; mean BMI was 42.2±5.1 kg/m2) or Lifestyle Counseling alone (n=70; mean BMI was 40.9±3.9 kg/m2). The co-primary end points were mean percent excess weight loss and the proportion of participants who achieved at least a 25% excess weight loss.Results:At 52 weeks, participants in the AspireAssist group, on a modified intent-to-treat basis, had lost a mean (±s.d.) of 31.5±26.7% of their excess body weight (12.1±9.6% total body weight), whereas those in the Lifestyle Counseling group had lost a mean of 9.8±15.5% of their excess body weight (3.5±6.0% total body weight) (P<0.001). A total of 58.6% of participants in the AspireAssist group and 15.3% of participants in the Lifestyle Counseling group lost at least 25% of their excess body weight (P<0.001). The most frequently reported adverse events were abdominal pain and discomfort in the perioperative period and peristomal granulation tissue and peristomal irritation in the postoperative period. Serious adverse events were reported in 3.6% of participants in the AspireAssist group.Conclusions:The AspireAssist System was associated with greater weight loss than Lifestyle Counseling alone.

Endoscopic bariatric and metabolic therapies: Another tool for the management of diabetes and obesity

“…In a 52‐week clinical trial by Thompson et al mean (±SD) TBWL was reported to be 12.1 ± 9.6% in the aspiration therapy group, compared with 3.5 ± 6.0% in the control group receiving lifestyle intervention alone ( P < 0.001). With regard to cardiometabolic risk factors, a clinically significant improvement in HbA1c, triglycerides, and high‐density lipoprotein was observed in this pivotal trial, with a modest decrease in low‐density lipoprotein and blood pressure compared with the control group . In one Swedish study, three of five patients with type 2 diabetes (T2D) were able to decrease or completely eliminate medical therapy while using aspiration therapy for 6 months …”

“…It is FDA approved for adults aged ≥22 years with a BMI of 35.0 to 55.0 kg/m 2 who have failed to achieve and maintain weight loss with non‐surgical therapy. Two studies conducted in the US have demonstrated that aspiration therapy is safe and effective for long‐term use and results in more weight loss than lifestyle intervention alone . In a 52‐week clinical trial by Thompson et al mean (±SD) TBWL was reported to be 12.1 ± 9.6% in the aspiration therapy group, compared with 3.5 ± 6.0% in the control group receiving lifestyle intervention alone ( P < 0.001).…”

“…Two studies conducted in the US have demonstrated that aspiration therapy is safe and effective for long‐term use and results in more weight loss than lifestyle intervention alone . In a 52‐week clinical trial by Thompson et al mean (±SD) TBWL was reported to be 12.1 ± 9.6% in the aspiration therapy group, compared with 3.5 ± 6.0% in the control group receiving lifestyle intervention alone ( P < 0.001). With regard to cardiometabolic risk factors, a clinically significant improvement in HbA1c, triglycerides, and high‐density lipoprotein was observed in this pivotal trial, with a modest decrease in low‐density lipoprotein and blood pressure compared with the control group .…”

“…The most common adverse events reported with this system include formation of peristomal granulation tissue, abdominal pain, nausea or vomiting, mild ulceration requiring apparatus removal, mild perioperative peritonitis, and fungal colonization . Contraindications for use include previous abdominal surgical intervention, ulcers, strictures or lesions, diagnosed bulimia or binge eating disorder, coagulopathy, or end‐stage organ dysfunction .…”

Novel Nonsurgical Endoscopic Approaches for the Treatment of Obesity

“…Data from the pivotal trial that led to eventual FDA approval for the AT system were a 52‐week randomized controlled trial of 207 subjects with a BMI of 35–55.0 kg/m 2 49 . Subjects were randomized in a 2:1 ratio to AT plus lifestyle treatment (n = 137) versus lifestyle alone (n = 70).…”