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

Obesity Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01422941
• Other study ID #: TP0271
• Status: Completed
• Phase: Phase 1
• First received: August 23, 2011
• Last updated: July 27, 2015
• Start date: October 2010

Study information

• Verified date: August 2011
• Source: Cavu Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Device:
• CAVU Attune Device
The CAVU Attune device is used with LAGB.

Locations

Country	Name	City	State
Australia	Institute of Weight Control	Baulkham Hills	New South Wales
Australia	St. George Private Hospital	Kogarah	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Cavu Medical, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of successful placement and filling of the CAVU Medical Attune device without serious device-related adverse events.		30 Days	Yes