Testing of 8mm A-Tube in AspireAssist™ Aspiration Therapy System
| ISRCTN | ISRCTN30159630 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30159630 |
| Secondary identifying numbers | 2014/3 |
- Submission date
- 30/04/2014
- Registration date
- 22/05/2014
- Last edited
- 22/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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
Contact information
Scientific
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Sweden
Study information
| Study design | A single centre single-arm study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | http://aspirebariatrics.com/about-the-aspireassist/ |
| Scientific title | Testing of 8mm A-Tube in AspireAssist™ Aspiration Therapy System: a single center / single- arm study |
| Study objectives | 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(s) | Regional Ethics Testing Board LUND,18/03/2014, ref. 2014/135 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 15/05/2014 |
| Completion date | 15/11/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 8 |
| Key inclusion criteria | Patient should currently be a user of the AspireAssist device and have used it for at least six (6) months |
| Key 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 |
| Date of first enrolment | 15/05/2014 |
| Date of final enrolment | 15/11/2014 |
Locations
Countries of recruitment
- Sweden
Study participating centre
371 85
Sweden
Sponsor information
Industry
3200 Horizon Drive, Suite 100
King of Prussia
19406
United States of America
| Phone | +1 610-590-1577 |
|---|---|
| info@aspirebariatrics.com | |
| Website | http://www.aspirebariatrics.com |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Not provided at time of registration. |
| IPD sharing plan | Do not intend to publish results |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 22/01/2019 | 22/01/2019 | No | No |
Additional files
- ISRCTN30159630_BasicResults_22Jan19.pdf
- Uploaded 22/01/2019
Editorial Notes
22/01/2019: The following changes have been made to the trial record:
1. The basic results of this trial have been uploaded as an additional file
2. The publication and dissemination plan has been changed
19/04/2017: Removed Dr. Forrsell as the study contact. New study contact to be determined. Added the individual participant level data sharing plan.
