Status:
COMPLETED
Safety and Performance of the CAVU Medical, Inc. Attune Tubing Study
Lead Sponsor:
Cavu Medical, Inc.
Conditions:
Obesity
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The objectives of this clinical research project are to demonstrate the safety and feasibility of CAVU Medical, Inc.'s Attune Device.
Eligibility Criteria
Inclusion
- The subject is at least 18 years of age.
- The subject has been informed of the nature of the trial and agrees to its provisions.
- The subject has a pre-implantation BMI within the protocol limits.
- The subject agrees to the follow-up visit schedule.
- The subject is a candidate for a LAGB procedure.
- The subject agrees to comply with specified follow-up evaluations.
- The subject is willing to fast for 2 hours prior to each adjustment visit.
Exclusion
- The subject is pregnant or is not willing to use an effective method of birth control for the duration of the trial.
- The subject has a condition that is contraindicated for LAGB procedures.
- The subject is currently using weight loss medications or supplements.
- The subject has a concurrent terminal medical condition with a life expectancy of less than 12 months.
- The subject is currently participating in an investigational drug or another medical device trial.
- The subject had a previous LAGB procedure.
- The Investigator believes that the patient has physical or mental conditions that would render trial participation inappropriate.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01422941
Start Date
October 1 2010
Last Update
July 28 2015
Active Locations (2)
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1
Institute of Weight Control
Baulkham Hills, New South Wales, Australia, 2154
2
St. George Private Hospital
Kogarah, New South Wales, Australia, 2217