Obesity
Conditions
Brief summary
Safety and efficacy evaluation of the BariTon™, BariaTek Medical gastric restriction and biliodigestive diversion device.
Interventions
The BariTon™ is endoscopically implanted and retrieved once treatment is completed
Sponsors
BariaTek Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male and female subjects aged between 25 and 60 years inclusive 2. A BMI between 30.0 and 40.0 kg/m2 inclusive with a history of obesity for at least 2 years and a history of failure of supervised weight loss program 3. Stable weight, i.e. \< 5% change in body weight for minimum of 3 months prior to enrolment 4. Willing and able to provide written informed consent 5. Willing and able to comply with the study procedures and follow-up schedule
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of the BariTon™ | 3 months | Number of patients with device implantation procedure success |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of the BariTon™ | 1 year | Number of patients with device retrieval procedure success |
| Efficacy of the BariTon™ | 1 year | Assessment of clinical variables and other metrics (exploratory) |
Countries
Australia
Contacts
Primary ContactChristophe Naz
Backup ContactYoussef Biadillah
Outcome results
None listed