A study to evaluate the safety and efficacy of AspireAssist™ in morbidly obese adolescents
| ISRCTN | ISRCTN36495438 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36495438 |
| Secondary identifying numbers | Protocol number 2016/3 |
- Submission date
- 19/07/2016
- Registration date
- 03/08/2016
- Last edited
- 19/04/2017
- 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 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
Contact information
Scientific
Pionyru 690
Nehvidzy
PSC 25081
Czech Republic
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Patient information can be found at: http://www.aspirebariatrics.com/ |
| Scientific title | A study to evaluate the safety and efficacy of AspireAssist™ in morbidly obese adolescents: a randomised controlled trial |
| Study objectives | 1. Aspire Assist ™ System gives no weight reduction 2. Quality of life is the same regardless of weight reduction |
| Ethics approval(s) | Vítkovice Hospital Ethics Committee, 25/06/2015 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 study start date | 01/09/2016 |
| Completion date | 31/03/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 40 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2016 |
| Date of final enrolment | 31/03/2017 |
Locations
Countries of recruitment
- Czech Republic
Study participating centre
Ostrava -Vítkovice
703 84
Czech Republic
Sponsor information
Hospital/treatment centre
Pionyru 690
Nehvidzy
PSC 25081
Czech Republic
Funders
Funder type
Industry
No information available
No information available
Results and Publications
| Intention to publish date | 31/03/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| 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 |
Editorial Notes
19/04/2017: Added individual participant level data sharing plan.
