ObesityPhase 1NCT01422941
Safety and Performance of the CAVU Medical, Inc. Attune Tubing Study
A Phase 1 study testing CAVU Attune Device in people with Obesity, run by Cavu Medical, Inc. at 2 sites in Australia.
Trial summary
The objectives of this clinical research project are to demonstrate the safety and feasibility of CAVU Medical, Inc.'s Attune Device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- CAVU Attune Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesAustralia
- Study dates
- Oct 2010to Jun 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Institute of Weight Control
Baulkham Hills, New South Wales, 2154
St. George Private Hospital
Kogarah, New South Wales, 2217
About this study
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)
The objectives of this clinical research project are to demonstrate the safety and feasibility of CAVU Medical, Inc.'s Attune Device.
- Conditions
- Obesity
- Being tested
- CAVU Attune Device
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAVU Attune DeviceDevice
The CAVU Attune device is used with LAGB.
| Study group | Role | What they receive |
|---|---|---|
| CAVU Attune Device | Experimental | Not described Receives: Device: CAVU Attune Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of successful placement and filling of the CAVU Medical Attune device without serious device-related adverse events.
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2011 (estimated)
- Study startOct 2010
- Primary completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cavu Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anthony Brancatisano, B Appl Sc, Principal investigator, Institute of Weight Control
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01422941
- Sponsor's protocol ID
- TP0271
- Status last verified
- Aug 2011
- First submitted
- 23 Aug 2011
- Last updated
- 28 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01422941
- Acronym / sponsor ID
- TP0271
- Conditions
- Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cavu Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Jun 2011 (actual)
- First posted
- 25 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this clinical research project are to demonstrate the safety and feasibility of CAVU Medical, Inc.'s Attune Device.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAVU Attune Device | Experimental | Device: CAVU Attune Device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAVU Attune DeviceThe CAVU Attune device is used with LAGB. | Device | CAVU Attune Device |
Primary outcome
The rate of successful placement and filling of the CAVU Medical Attune device without serious device-related adverse events.
Time frame: 30 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Brancatisano, B Appl Sc principal investigator
Institute of Weight Control
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CAVU Attune Device in people with Obesity, run by Cavu Medical, Inc. at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of successful placement and filling of the CAVU Medical Attune device without serious device-related adverse events. (time frame: 30 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2015.