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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Cavu Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01422941
First received: August 23, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


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 ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: April 2011
Estimated Primary Completion Date: October 2012 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Cavu Medical, Inc.
ClinicalTrials.gov Identifier: NCT01422941     History of Changes
Other Study ID Numbers: TP0271
Study First Received: August 23, 2011
Last Updated: August 23, 2011
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 31, 2014