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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01422941
First Posted: August 25, 2011
Last Update Posted: July 28, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cavu Medical, Inc.
  Purpose
The objectives of this clinical research project are to demonstrate the safety and feasibility of CAVU Medical, Inc.'s Attune Device.

Condition Intervention Phase
Obesity Device: CAVU Attune Device Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)

Further study details as provided by Cavu Medical, Inc.:

Primary Outcome Measures:
  • The rate of successful placement and filling of the CAVU Medical Attune device without serious device-related adverse events. [ Time Frame: 30 Days ]

Enrollment: 40
Study Start Date: October 2010
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CAVU Attune Device Device: CAVU Attune Device
The CAVU Attune device is used with LAGB.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01422941


Locations
Australia, New South Wales
Institute of Weight Control
Baulkham Hills, New South Wales, Australia, 2154
St. George Private Hospital
Kogarah, New South Wales, Australia, 2217
Sponsors and Collaborators
Cavu Medical, Inc.
Investigators
Principal Investigator: Anthony Brancatisano, B Appl Sc Institute of Weight Control
  More Information

Responsible Party: Cavu Medical, Inc.
ClinicalTrials.gov Identifier: NCT01422941     History of Changes
Other Study ID Numbers: TP0271
First Submitted: August 23, 2011
First Posted: August 25, 2011
Last Update Posted: July 28, 2015
Last Verified: August 2011