Safety and Performance of the CAVU Medical, Inc. Attune Tubing Study

Phase 1

Completed

• Conditions: Obesity
• Interventions: Device: CAVU Attune Device

• Registration Number: NCT01422941
• Lead Sponsor: Cavu Medical, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Primary Completion: 2011-06
• Status Verified: 2011-08
• Study First Submitted: 2011-08-23
• Study First Submitted QC: 2011-08-23
• Study First Posted: 2011-08-25
• Last Update Submitted: 2015-07-27
• Last Update Posted: 2015-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CAVU Attune Device	CAVU Attune Device	-

Primary Outcome Measures

Name	Time	Method
The rate of successful placement and filling of the CAVU Medical Attune device without serious device-related adverse events.	30 Days

Trial Locations

Locations (2)

Institute of Weight Control; 🇦🇺 Baulkham Hills, New South Wales, Australia

St. George Private Hospital; 🇦🇺 Kogarah, New South Wales, Australia