A PROSPECTIVE, MULTI-CENTER CLINICAL EVALUATION TO ASSESS SAFETY AND PERFORMANCE OF CAVU MEDICAL, INC.'S ATTUNE TUBING WHEN USED WITH NEWLY-IMPLANTED LAPAROSCOPIC ADJUSTABLE GASTRIC BANDS (LAGBs)

Cavu Medical, Inc.2 sites in 1 country40 target enrollmentOctober 2010

ConditionsObesity

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Obesity
Sponsor: Cavu Medical, Inc.
Enrollment: 40
Locations: 2
Primary Endpoint: The rate of successful placement and filling of the CAVU Medical Attune device without serious device-related adverse events.
Status: Completed
Last Updated: 10 years ago

The objectives of this clinical research project are to demonstrate the safety and feasibility of CAVU Medical, Inc.'s Attune Device.

Registry

clinicaltrials.gov

Start Date

October 2010

End Date

June 2011

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

Cavu Medical, Inc.

Responsible Party

Sponsor

•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.

•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.