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Am J Gastroenterol. 2017 Mar;112(3):447-457. doi: 10.1038/ajg.2016.500. Epub 2016 Dec 6.

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

Author information

1
Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Boston, Massachusetts, USA.
2
Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.
3
Division of Endocrinology, Metabolism and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
4
Division of Gastroenterology, Washington University in St Louis, St Louis, Missouri, USA.
5
Division of Endocrinology, St Mary Medical Center, Langhorne, Pennsylvania, USA.
6
Division of Endocrinology, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
7
Nutrition and Weight Management Center, Boston Medical Center, Boston, Massachusetts, USA.
8
Division of Minimally Invasive and Bariatric Surgery, Howard University, Washington, District of Columbia, USA.
9
Division of Gastroenterology, University of California, San Diego, California, USA.
10
Division of Endocrinology, Diabetes, Metabolism and Nutrition, Mayo Clinic, Rochester, Minnesota, USA.
11
Division of Gastroenterology and Hepatology, Northwestern University School of Medicine, Chicago, Illinois, USA.
12
Washington University in St Louis, St Louis, Missouri, USA.
13
Division of Gastroenterology, Weill Cornell Medical College, New York, New York, USA.
14
Division of Gastroenterology, St Mary Medical Center, Langhorne, Pennsylvania, USA.
15
Division of Gastroenterology, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
16
Section of Gastroenterology, Boston Medical Center, Boston, Massachusetts, USA.
17
Center for Wellness and Weight Loss Surgery, Howard University, Washington, District of Columbia, USA.
18
VA San Diego Healthcare System, San Diego, California, USA.
19
Northwestern University School of Medicine, Chicago, Illinois, USA.
20
Section of Gastroenterology, VA San Diego Healthcare System, San Diego, California, USA.
21
Weill Cornell Medical College, New York, New York, USA.
22
Brigham and Women's Hospital, Boston, Masachusetts, USA.
23
St Mary Medical Center, Langhorne, Pennsylvania, USA.
24
Aspire Bariatrics, Inc., King of Prussia, Pennsylvania, USA.

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.

PMID:
27922026
PMCID:
PMC5350543
DOI:
10.1038/ajg.2016.500
[Indexed for MEDLINE]
Free PMC Article

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