Plain English Summary
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
monica.ferrante@aspirebariatrics.com
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2014/3
Study information
Scientific title
Testing of 8mm A-Tube in AspireAssist™ Aspiration Therapy System: a single center / single- arm study
Acronym
Study hypothesis
Hypothesis (H0): Aspire Assist ™ Aspiration Therapy System with modified 8mm A-Tube gives the same aspiration time and blockage frequency as the original 6mm A-tube.
Ethics approval
Regional Ethics Testing Board LUND,18/03/2014, ref. 2014/135
Study design
A single centre single-arm study
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
http://aspirebariatrics.com/about-the-aspireassist/
Condition
Treatment of Obesity
Intervention
This AspireAssist Aspiration Therapy study is an interventional study without a control. The intervention requires percutaneous endoscopic replacement of the 6mm A-Tube which is similar to a standard PEG tube, with an 8mm A-Tube using the pull method. The tube is then used to drain the remaining stomach contents to reduce the caloric intake from the meal. This aspiration process is intended to be performed 20 minutes after each major meal of the day (3x per day) to achieve weight loss. This is implemented as non-RCT study. The device is currently CE Marked and commercially available in the EU.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. The dependent variable: aspiration time, number of blockages of food at the start of the study and at 7 weeks
2. Independent variables: 6mm A-Tube or 8mm A-Tube, chewing time
Secondary outcome measures
1. The dependent variable: complications (yes/no)
2. Independent variables: 6mm A-Tube or 8mm A-Tube
Overall trial start date
15/05/2014
Overall trial end date
15/11/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patient should currently be a user of the AspireAssist device and have used it for at least six (6) months
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
8
Participant exclusion criteria
1. Active infection at the A-Tube
2. Recent (1 month) myocardial infarction
3. The patient is for some reason not considered likely to follow the instructions in the study with respect to diary completion
Recruitment start date
15/05/2014
Recruitment end date
15/11/2014
Locations
Countries of recruitment
Sweden
Trial participating centre
Kirurgkliniken Blekingesjukhuset
Karlskrona
371 85
Sweden
Sponsor information
Organisation
Aspire Bariatrics, Inc. (USA)
Sponsor details
3200 Horizon Drive
Suite 100
King of Prussia
19406
United States of America
+1 610-590-1577
info@aspirebariatrics.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Aspire Bariatrics, Inc (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration.
IPD sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date
Intention to publish date
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list