Condition category
Nutritional, Metabolic, Endocrine
Date applied
30/04/2014
Date assigned
22/05/2014
Last edited
23/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Henrik Forrsell

ORCID ID

Contact details

Kirurgkliniken Blekingesjukhuset
Karlskrona
371 85
Sweden

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 measures

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

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

http://www.aspirebariatrics.com

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

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes