Gastric Bypass Procedure and AspireAssist Aspiration Therapy System for the Treatment of Morbid Obesity, Observational Study Over 5 Years
Sponsor study identifier
observational
100
1 country
1
Study Start
May 2014
Actual (reported)Primary Completion
May 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The purpose of this study is to compare Gastric Bypass and AspireAssist Aspiration Therapy over 5 years of treatment with regards to weight loss, quality of life, complications, adverse events, and health economics.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2014
Actual (reported)May 14, 2014
Actual (reported)May 20, 2014
Actual (reported)May 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Weight Loss
% Excess Weight loss based on ideal body weight with BMI of 25
year 1 - quarterly, years 2-5 once per year
Quality of Life
annually, up to 5 years
Complications
within 30 days of procedure, after 30 days
Morbidly obese individuals who meet the criteria for and have chosen to undergo Gastric Bypass surgery.
Morbidly obese individuals who meet the criteria for and have chosen to participate in Aspiration Therapy using the AspireAssist.
Gastric Bypass surgery reduces the size of the stomach by use of staples. The smaller gastric pouch is then connected to the intestine bypassing a portion of the small intestine.
AspireAssist employs an endoscopically placed A-Tube (similar to a gastrostomy tube) and a Companion system which facilitates portion control by aspiration of stomach contents 20 minutes after each meal combined with behavioral Therapy.
The study is a prospective investigation of patients in Blekinge with a diagnosis of obesity. A total of 100 patients will be included consecutively in the study. The distribution will be 50 patients for each group. Recruitment for Gastric Bypass is made from the clinic's waiting list for obesity surgery and for AspireAssist those individuals' self-reported interest for treatment with AspireAssist.
Blekinge County Council Hospital
Karlskrona, 371 85, Sweden
Max O Nystrom, MD
Blekinge County Council Hospital
100 participants (actual enrollment reported by the registry).
First Submitted
May 14, 2014
First Posted
May 20, 2014
Study Start
May 2014
Actual (reported)Pivotal Aspiration Therapy With Adjusted Lifestyle Therapy Study
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
May 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 30, 2018
Record last verified: 2018-04
There is no plan to share individual participant data.
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Source: ClinicalTrials.gov.
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