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Completed

NCT Number: NCT01422941

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

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

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Institute of Weight Control, Baulkham Hills, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The subject is at least 18 years of age.
  • The subject has been informed of the nature of the trial and agrees to its provisions.
  • The subject has a pre-implantation BMI within the protocol limits.
  • The subject agrees to the follow-up visit schedule.
  • The subject is a candidate for a LAGB procedure.
  • The subject agrees to comply with specified follow-up evaluations.
  • The subject is willing to fast for 2 hours prior to each adjustment visit.

Exclusion criteria

  • The subject is pregnant or is not willing to use an effective method of birth control for the duration of the trial.
  • The subject has a condition that is contraindicated for LAGB procedures.
  • The subject is currently using weight loss medications or supplements.
  • The subject has a concurrent terminal medical condition with a life expectancy of less than 12 months.
  • The subject is currently participating in an investigational drug or another medical device trial.
  • The subject had a previous LAGB procedure.
  • The Investigator believes that the patient has physical or mental conditions that would render trial participation inappropriate.

Treatment and study plan

CAVU Attune Device

Device

The CAVU Attune device is used with LAGB.

Primary outcomes

  1. The rate of successful placement and filling of the CAVU Medical Attune device without serious device-related adverse events.

    Time frame: 30 Days

Sponsors and collaborators

Lead sponsor

Cavu Medical, Inc.

Industry

Registry information

Official study 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)

Important dates

Study start
2010
Primary completion
2011
First posted
Aug 25, 2011
Registry last updated
Jul 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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