Obesity
Conditions
Brief summary
The objectives of this clinical research project are to demonstrate the safety and feasibility of CAVU Medical, Inc.'s Attune Device.
Interventions
DEVICECAVU Attune Device
The CAVU Attune device is used with LAGB.
Sponsors
Cavu Medical, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The subject is at least 18 years of age. 2. The subject has been informed of the nature of the trial and agrees to its provisions. 3. The subject has a pre-implantation BMI within the protocol limits. 4. The subject agrees to the follow-up visit schedule. 5. The subject is a candidate for a LAGB procedure. 6. The subject agrees to comply with specified follow-up evaluations. 7. The subject is willing to fast for 2 hours prior to each adjustment visit.
Exclusion criteria
1. The subject is pregnant or is not willing to use an effective method of birth control for the duration of the trial. 2. The subject has a condition that is contraindicated for LAGB procedures. 3. The subject is currently using weight loss medications or supplements. 4. The subject has a concurrent terminal medical condition with a life expectancy of less than 12 months. 5. The subject is currently participating in an investigational drug or another medical device trial. 6. The subject had a previous LAGB procedure. 7. The Investigator believes that the patient has physical or mental conditions that would render trial participation inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of successful placement and filling of the CAVU Medical Attune device without serious device-related adverse events. | 30 Days |
Countries
Australia
Outcome results
None listed