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

NCT01422941 | Completed Phase 1 DMC

• 1 other identifier: TP0271
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

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

  30 Days

Study Arms (1)

CAVU Attune Device

EXPERIMENTAL

Device: CAVU Attune Device

Interventions

CAVU Attune Device DEVICE

The CAVU Attune device is used with LAGB.

CAVU Attune Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cavu Medical, Inc.: lead

Study Sites (2)

Institute of Weight Control

Baulkham Hills, New South Wales, 2154, Australia

Location

St. George Private Hospital

Kogarah, New South Wales, 2217, Australia

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Anthony Brancatisano, B Appl Sc

  Institute of Weight Control

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2011
• First Posted: August 25, 2011
• Study Start: October 1, 2010
• Primary Completion: June 1, 2011
• Last Updated: July 28, 2015

Record last verified: 2011-08

Locations

AU (2)