Woman and Man
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Extract
Background and study aims Obesity is a serious issue in the western world for which there are now a number of treatments including diet, drugs and invasive obesity surgery. An alternative approach, the AspireAssist ™ Aspiration Therapy System (CE-approved), comes from the United States and involves the patient removing a portion of a meal from the stomach before the calories are absorbed into the body, causing weight loss. A specially designed tube is placed into the stomach through the abdominal wall. Using an ingeniously designed valve mechanism and associated drain tube and water reservoir, the patient can empty (aspirate) some of their stomach contents into a toilet. Early results show that the method works; patients lose an average of 49% of their excess weight within a year and without any serious complications. Unlike many other surgical weight loss procedures, this treatment is simple, reversible and does not cause any change in anatomy. The procedure is performed under conscious sedation, takes between 20-30 minutes and patients can normally return home within a couple of hours. The original AspireAssist A-Tube is 6mm in diameter. Here, we are testing whether widening tube diameter to 8mm will result in a reduction in aspiration time and frequency needed to achieve weight loss and whether it will result in less tube blockages. Who can participate? Patients that are currently users of the AspireAssist device and have been for at least the last six months. What does the study involve? The 6mm tube is replaced with a 8mm tube. The patient then uses the tube to empty a portion of their stomach contents 20 minutes after every major meal. What are the possible benefits and risks of participating? The potential benefits include reducing the time taken and the frequency needed for aspiration and also in the number of tube blockages. Where is the study run from? Blekinge County Council Hospital (Sweden) When is the study starting and how long is it expected to run for? From May 2014 to November 2014 Who is funding the study? Aspire Bariatrics, Inc (USA) Who is the main contact? Dr Monica Ferrante [email protected]
Inclusion criteria
- Treatment of Obesity