Persistent Weight Loss with a Non-invasive Novel Medical Device In Obese Individuals With High-risk Cardiovascular Risk Profile
Not Applicable
- Conditions
- E66.9Obesity, unspecified
- Registration Number
- DRKS00011357
- Lead Sponsor
- Praxis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 6
Inclusion Criteria
1. Age: 18 to 95 years
2. Gender: male + female
3. Capacity to consent
4. Signed consent form
5. Failure of a basic program (nutritional, exercise and behavioural therapy)
6. Received medical device
7. at least 2 documented visits after receiving the medical device
Exclusion Criteria
1. Weight reduction > 5% over the last months before inclusion into the study
2. Wasting disease
3. Medication influeincing weight loss
4. Pregnancy or breastfeeding women
5. Mental disorders or non-compliance
6. Incapacity to give informed consent
7. Participation in another therapy program or study
8. Exclsuion by dentist for dental of maxillary joint problems
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PEP is efficiency (weight reduction) of the medical device.
- Secondary Outcome Measures
Name Time Method The security of the medical device will be controlled through regular visits and participants have been advised to present immediately if problems occur. Anthropometric measurements will be done and they will be asked to complete two questionnaires during usage of the medical device. Furthermore participants will be followed up through telephone contacts. Detailed informations about the medical device will be given in a separate information brochure.<br>The mode of action will be assessed through questionnaires at the beginning and end of usage of the medical device.