Body Fat DisorderJUNONCT01579487
Extended Follow-Up Study for Subjects Who Participated in 2010 Study
A study testing The Zeltiq System in people with Body Fat Disorder, run by Zeltiq Aesthetics at 1 site in United States.
Trial summary
This study is being performed to follow up on subjects who participated in the initial study (ZA10-001) in 2010. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Body Fat Disorder
- What is being tested?
- The Zeltiq System
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Feb 2013
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject participated in the ZA10-001 study, and received all study treatments.
- Subject has read and signed a written informed consent form.
Who cannot join
- Subject has had any surgical or aesthetic procedure(s) in or around the abdomen since the completion of the ZA10-001 study treatments.
- Subject is pregnant.
- Subject is unable or unwilling to comply with the study requirements.
- Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
- Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the integrity of the data.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-Invasive Reduction of Abdominal Fat Utilizing the JUNO Applicator
This study is being performed to follow up on subjects who participated in the initial study (ZA10-001) in 2010.
Read the detailed description
The primary objective of this investigation is to assess the durability of treatment outcomes with the ZELTIQ System.
- Conditions
- Body Fat Disorder
- Being tested
- The Zeltiq System
- Keywords
- Lipolysis, Cryolipolysis, Fat Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Zeltiq SystemDevice
Also called Cryolipolysis, Lipolysis
This is a follow-up study from the initial treatments performed in 2010. No additional treatments will be performed.
What is being measured
The primary outcome is the main question the study is designed to answer.
Independent Photo Review
The primary effectiveness endpoint is the correct identification of the series of pre-treatment images by the three reviewers.
Measured: 12+ mos post treatment
Secondary outcomes (2)
Access reduction
Reduction in the fat layer thickness
Measured: 12+ mos post treatment
Subject Satisfaction
Subject satisfaction with the Zeltiq procedure as determined by the results of a subjects satisfaction questionnaire at the follow up visit.
Measured: 12+ mos post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionApr 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Fat DisorderStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeltiq Aesthetics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Flor Mayoral, MD, Principal investigator, Mayoral Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01579487
- Sponsor's protocol ID
- ZA10-001.A1-EXT
- Acronym
- JUNO
- Status last verified
- Mar 2012
- First submitted
- 15 Mar 2012
- Last updated
- 22 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Reduction of Abdominal Fat Utilizing the JUNO Applicator
- ClinicalTrials.gov ID
- NCT01579487
- Acronym / sponsor ID
- JUNO / ZA10-001.A1-EXT
- Conditions
- Body Fat Disorder
- Keywords
- Lipolysis, Cryolipolysis, Fat Reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Zeltiq AestheticsIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Apr 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 18 Apr 2012 (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.
This study is being performed to follow up on subjects who participated in the initial study (ZA10-001) in 2010.
Detailed description
The primary objective of this investigation is to assess the durability of treatment outcomes with the ZELTIQ System.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject participated in the ZA10-001 study, and received all study treatments.
- Subject has read and signed a written informed consent form.
Key exclusion criteria (5 listed)
- Subject has had any surgical or aesthetic procedure(s) in or around the abdomen since the completion of the ZA10-001 study treatments.
- Subject is pregnant.
- Subject is unable or unwilling to comply with the study requirements.
- Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
- Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the integrity of the data.
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 |
|---|---|---|
| The Zeltiq SystemAlso: Cryolipolysis, LipolysisThis is a follow-up study from the initial treatments performed in 2010. No additional treatments will be performed. | Device | – |
Primary outcome
Independent Photo Review
Time frame: 12+ mos post treatment
The primary effectiveness endpoint is the correct identification of the series of pre-treatment images by the three reviewers.
2 secondary outcomes
Access reduction
Time frame: 12+ mos post treatment
Subject Satisfaction
Time frame: 12+ mos post treatment
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 22 Jun 2017.
- Individual participant dataSharing planned: No
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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.
Flor Mayoral, MD principal investigator
Mayoral Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Zeltiq System in people with Body Fat Disorder, run by Zeltiq Aesthetics at 1 site in United States.
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 2 inclusion and 5 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 22 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
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?
Independent Photo Review (time frame: 12+ mos post treatment). 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 22 Jun 2017.