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

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)

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

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Device: CAVU Attune Device

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Baulkham Hills, New South Wales, Australia, 2154
      • Institute of Weight Control
    • Kogarah, New South Wales, Australia, 2217
      • St. George Private Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CAVU Attune Device	Device: CAVU Attune Device; The CAVU Attune device is used with LAGB.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cavu Medical, Inc.
• Investigators: Principal Investigator: Anthony Brancatisano, B Appl Sc, Institute of Weight Control

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (ACTUAL): June 1, 2011

Study Registration Dates

• First Submitted: August 23, 2011
• First Submitted That Met QC Criteria: August 23, 2011
• First Posted (ESTIMATE): August 25, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): July 28, 2015
• Last Update Submitted That Met QC Criteria: July 27, 2015
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Other Study ID Numbers: TP0271