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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01422941




Registration number
NCT01422941
Ethics application status
Date submitted
23/08/2011
Date registered
25/08/2011
Date last updated
28/07/2015

Titles & IDs
Public title
Safety and Performance of the CAVU Medical, Inc. Attune Tubing Study
Scientific 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)
Secondary ID [1] 0 0
TP0271
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - CAVU Attune Device

Experimental: CAVU Attune Device -


Treatment: Devices: CAVU Attune Device
The CAVU Attune device is used with LAGB.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The rate of successful placement and filling of the CAVU Medical Attune device without serious device-related adverse events.
Timepoint [1] 0 0
30 Days

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Institute of Weight Control - Baulkham Hills
Recruitment hospital [2] 0 0
St. George Private Hospital - Kogarah
Recruitment postcode(s) [1] 0 0
2154 - Baulkham Hills
Recruitment postcode(s) [2] 0 0
2217 - Kogarah

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Cavu Medical, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The objectives of this clinical research project are to demonstrate the safety and
feasibility of CAVU Medical, Inc.'s Attune Device.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01422941
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Anthony Brancatisano, B Appl Sc
Address 0 0
Institute of Weight Control
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries