Condition category
Nutritional, Metabolic, Endocrine
Date applied
19/07/2016
Date assigned
03/08/2016
Last edited
03/08/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Obesity is a medical term used to describe someone who is very overweight. It is generally caused by eating too much and doing too little exercise. Being obese can lead to a number of serious and potentially life changing conditions including type 2 diabetes, coronary heart disease, some cancers (e.g. breast and bowel cancers) and stroke. It can also affect a person’s mental well-being, leading to low self-esteem and depression.Surgery can help people to lose weight. One approach, Aspire Assist ™ (CE approved), comes from the United States and involves the patient emptying some portion of their meal from the stomach. A gastroscopy procedure is used to place a special tube from the stomach through the abdominal wall. Using a valve mechanism and associated drain tube and water reservoir, the patient can empty the stomach contents into a toilet. This should be done about 20 minutes after the meal and this will result in removal of a portion of the calories from the meal. Previous research has shown that the method works in adults and leads to an average of 49 % reduction of excess weight during the course of a year. The aim of this study is to see whether the Aspire Assist ™ system leads to weight loss in younger people who are obese (adolescents) and an improvement in their quality of life.

Who can participate?
Young people aged between 16-21 with a body mass index of 35 to 55 kg/ m2.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in group 1 receive the device. Those in group 2 do not receive the device but are treated as usual for their condition. For participants in group 1, a special tube is used to drain the contents of the stomach 20 minutes after a main meal (breakfast, lunch and dinner) is eaten. This is done to reduce the number of calories being absorbed from the meal. All participants are followed up for the next 12 months and are assessed as 3, 6 and 12 months to see how much weight they have lost.

What are the possible benefits and risks of participating?
One major benefit of this treatment (when compared to other surgical treatments for obesity) is that it is completely reversible and if the patient who does not wish to continue the therapy can have the tube removed. It does not alter the anatomy of the stomach in any way. There is a low risk of mild peritonitis. There is generally post-procedure pain and discomfort from inserting the special tube which resolves quickly and can be treated by pain medication. There may be some nausea and vomiting as a result of sedation and medications. Once under therapy risks are associated with maintaining the stoma site (site where the tube protrudes from the stomach). These include leakage or discharge from the stoma site and some abdominal discomfort. Infrequently there have been fungal infections at the stoma site. All are treatable and seem to be well tolerated by adult patients.

Where is the study run from?
Vítkovice Hospital Surgical Ward (Czech Republic)

When is the study starting and how long is it expected to run for?
September 2016 to March 2019

Who is funding the study?
1. Suppmed, Inc
2. Aspire Bariatrics, Inc

Who is the main contact?
Dr Evžen Machytka

Trial website

Contact information

Type

Scientific

Primary contact

Dr Evžen Machytka

ORCID ID

Contact details

Pionyru 690
Nehvidzy
PSC 25081
Czech Republic

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Protocol number 2016/3

Study information

Scientific title

A study to evaluate the safety and efficacy of AspireAssist™ in morbidly obese adolescents: a randomised controlled trial

Acronym

Study hypothesis

1. Aspire Assist ™ System gives no weight reduction
2. Quality of life is the same regardless of weight reduction

Ethics approval

Vítkovice Hospital Ethics Committee, 25/06/2015

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Patient information can be found at: http://www.aspirebariatrics.com/

Condition

Adolescent obesity

Intervention

This AspireAssist study is an interventional study with a control.

The study is designed as a two-arm study with randomization in the proportion of 20 subjects in the treatment group receiving the AspireAssist and 20 subjects in the control group receiving conservative treatment. 20 patients who will undergo implantation of the AspireAssist Device and complete the study protocol in the 12 months following the implantation of the device. Obese adolescents will be enrolled into one of the two arms of the study:

Arm 1: Obese patients with the AspireAssist device
Arm 2: Obese patients treated conservatively

The intervention requires percutaneous endoscopic placement of the A-Tube which is similar to a standard PEG tube, in adolescent subjects with BMI of between 35 and 55 kg/m2. 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. The device is currently CE Marked and commercially available in the EU. The therapy has already been the subject of several studies and is also the subject of a randomized controlled trial in adult subjects in the US under ClinicalTrials.gov NCT01766037.

Intervention type

Device

Phase

Drug names

Primary outcome measures

Body weight reduction measured as % Total Body Weight loss will be evaluated at 3, 6 and 12 months of treatment.

Secondary outcome measures

1. Waist circumference and BMI changes
2. Body composition changes – evaluation of fatty tissue volume reduction
3. Tolerance of the aspiration method by adolescents (to be measured with AspireAssist patient satisfaction survey)
4. Changes in food intake and dietary habits (to be measured with AspireAssist patient satisfaction survey)
5. Quality of life improvement assessed by means of IWQOL and SF-36.

These are all evaluated at 3, 6 and 12 months.

Overall trial start date

01/09/2016

Overall trial end date

31/03/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 16 to 21 years at the time of selection for the study
2. Body mass index (BMI) 35 to 55 kg/ m2
3. Comorbidities such as hypertension and dyslipidemia treated by an appropriate specialist are permissible
4. Ability to comprehend the content of the informed consent form.
5. Cooperation of the subject's parents
6. Non-smoker

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. BMI below 35 or above 55
2. History of stomach and gallbladder surgeries
3. Previous technical difficulties with gastroduodenoscopy or a failure to carry out an endoscopy
4. Type 1 diabetes
5. Insulin therapy
6. History of gastrointestinal disease (acute gastritis, non-specific colitis)
7. Confirmed celiac disease
8. History of malignity
9. Previous endoscopic and surgical treatment of obesity (intragastric balloons, endoscopic or surgical gastric procedures, malabsorptive procedures of the GIT)
10. Specific genetic or hormonal disorders associated with obesity (Prader-Wili syndrome, MC4R mutation etc.)
11. Coagulation and hemopoiesis disorders
12. Both chronic and acute pancreatitis
13. Psychiatric disorders (endogenous depression, schizophrenia, suicidal tendencies, psychoses)
14. Uncontrolled hypertension (systolic BP > 150 mm Hg or diastolic BP > 100 mm Hg)
15. Autoimmune diseases or long-term use of systemic glucocorticoids or immunosuppressive therapy
16. Thyroid function disorders unresponsive to treatment
17. Kidney function disorders with GFR < 60 mL/min/1.73 m2 or albumin excretion > 1000 mg/day

Recruitment start date

01/09/2016

Recruitment end date

31/03/2017

Locations

Countries of recruitment

Czech Republic

Trial participating centre

Vítkovice Hospital Surgical Ward
Zalužanského 1192/15
Ostrava -Vítkovice
703 84
Czech Republic

Sponsor information

Organisation

Vítkovicke Hospital

Sponsor details

Pionyru 690
Nehvidzy
PSC 25081
Czech Republic

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Suppmed, Inc.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Aspire Bariatrics, Inc

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

31/03/2020

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes