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

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) coun...

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Published in:	The American journal of gastroenterology Vol. 112; no. 3; pp. 447 - 457
Main Authors:	Thompson, Christopher C, Abu Dayyeh, Barham K, Kushner, Robert, Sullivan, Shelby, Schorr, Alan B, Amaro, Anastassia, Apovian, Caroline M, Fullum, Terrence, Zarrinpar, Amir, Jensen, Michael D, Stein, Adam C, Edmundowicz, Steven, Kahaleh, Michel, Ryou, Marvin, Bohning, Matthew J, Ginsberg, Gregory, Huang, Christopher, Tran, Daniel D, Glaser, Joseph P, Martin, John A, Jaffe, David L, Farraye, Francis A, Ho, Samuel B, Kumar, Nitin, Harakal, Donna, Young, Meredith, Thomas, Catherine E, Shukla, Alpana P, Ryan, Michele B, Haas, Miki, Goldsmith, Heidi, McCrea, Jennifer, Aronne, Louis J
Format:	Journal Article
Language:	English
Published:	United States Wolters Kluwer Health Medical Research, Lippincott Williams & Wilkins 01.03.2017 Nature Publishing Group
Subjects:	Abdominal Pain - epidemiology Adult Diet Therapy Drainage - methods Endoscopy Exercise Therapy Female Gastroenterology Gastrostomy - methods Granulation Tissue Humans Male Middle Aged Obesity - therapy Postoperative Complications - epidemiology Treatment Outcome Weight Loss
ISSN:	0002-9270, 1572-0241
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Abstract	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. In this 52-week clinical trial, 207 participants with a body-mass index (BMI) of 35.0-55.0 kg/m 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/m ) or Lifestyle Counseling alone (n=70; mean BMI was 40.9±3.9 kg/m ). 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. 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. The AspireAssist System was associated with greater weight loss than Lifestyle Counseling alone.
AbstractList	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/m super(2) were randomly assigned in a 2:1 ratio to treatment with AspireAssist plus Lifestyle Counseling (n=137; mean BMI was 42.2 plus or minus 5.1 kg/m super(2)) or Lifestyle Counseling alone (n=70; mean BMI was 40.9 plus or minus 3.9 kg/m super(2)). 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 ( plus or minus s.d.) of 31.5 plus or minus 26.7% of their excess body weight (12.1 plus or minus 9.6% total body weight), whereas those in the Lifestyle Counseling group had lost a mean of 9.8 plus or minus 15.5% of their excess body weight (3.5 plus or minus 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. 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. In this 52-week clinical trial, 207 participants with a body-mass index (BMI) of 35.0-55.0 kg/m 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/m ) or Lifestyle Counseling alone (n=70; mean BMI was 40.9±3.9 kg/m ). 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. 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. The AspireAssist System was associated with greater weight loss than Lifestyle Counseling alone. 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. OBJECTIVESThe 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.METHODSIn 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.RESULTSAt 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.CONCLUSIONSThe AspireAssist System was associated with greater weight loss than Lifestyle Counseling alone.
Author	Apovian, Caroline M Jensen, Michael D Glaser, Joseph P Farraye, Francis A Thompson, Christopher C Kahaleh, Michel Haas, Miki Abu Dayyeh, Barham K McCrea, Jennifer Ho, Samuel B Ryou, Marvin Huang, Christopher Schorr, Alan B Harakal, Donna Ginsberg, Gregory Thomas, Catherine E Shukla, Alpana P Aronne, Louis J Fullum, Terrence Young, Meredith Kumar, Nitin Zarrinpar, Amir Kushner, Robert Goldsmith, Heidi Sullivan, Shelby Bohning, Matthew J Ryan, Michele B Martin, John A Amaro, Anastassia Jaffe, David L Tran, Daniel D Stein, Adam C Edmundowicz, Steven
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BackLink	https://www.ncbi.nlm.nih.gov/pubmed/27922026$$D View this record in MEDLINE/PubMed
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Copyright	Copyright Nature Publishing Group Mar 2017 Copyright © 2017 American College of Gastroenterology 2017 American College of Gastroenterology
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References	Langeveld (R5-16-20210210) 2015; 23 Allison (R25-16-20210210) 2011; 20 Sumithran (R18-16-20210210) 2011; 365 Abell (R17-16-20210210) 2008; 103 Buchwald (R4-16-20210210) 2013; 23 Itkin (R24-16-20210210) 2011; 141 Li (R2-16-20210210) 2015; 11 Jensen (R21-16-20210210) 2014; 63 Xia (R3-16-20210210) 2015; 23 Sullivan (R6-16-20210210) 2013; 145 Rahnemai-Azar (R9-16-20210210) 2014; 20 Smith (R26-16-20210210) 2010; 363 Kolotkin (R15-16-20210210) 2001; 9 Nicholson (R27-16-20210210) 2000; 15 Bochicchio (R23-16-20210210) 2006; 10 Wiggins (R22-16-20210210) 2009; 24 Kramer (R19-16-20210210) 1989; 13 Chao (R16-16-20210210) 2000; 48 Klein (R1-16-20210210) 2002; 123 28270668 - Am J Gastroenterol. 2017 Mar;112(3):458-589
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Snippet	The AspireAssist System (AspireAssist) is an endoscopic weight loss device that is comprised of an endoscopically placed percutaneous gastrostomy tube and an... Objectives:The AspireAssist System (AspireAssist) is an endoscopic weight loss device that is comprised of an endoscopically placed percutaneous gastrostomy... OBJECTIVESThe AspireAssist System (AspireAssist) is an endoscopic weight loss device that is comprised of an endoscopically placed percutaneous gastrostomy... Objectives: The AspireAssist System (AspireAssist) is an endoscopic weight loss device that is comprised of an endoscopically placed percutaneous gastrostomy...
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SubjectTerms	Abdominal Pain - epidemiology Adult Diet Therapy Drainage - methods Endoscopy Exercise Therapy Female Gastroenterology Gastrostomy - methods Granulation Tissue Humans Male Middle Aged Obesity - therapy Postoperative Complications - epidemiology Treatment Outcome Weight Loss
Title	Percutaneous Gastrostomy Device for the Treatment of Class II and Class III Obesity: Results of a Randomized Controlled Trial
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