Fat ReductionJUNONCT01101997
Non-Invasive Reduction of Abdominal Fat
A study testing The Zeltiq System in people with Fat Reduction, run by Zeltiq Aesthetics at 5 sites in United States.
Trial summary
This study is being performed to reduce unwanted abdominal fat using a new applicator for the Zeltiq System. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fat Reduction
- What is being tested?
- The Zeltiq System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 5 sitesUnited States
- Study dates
- 30 Mar 2010to 8 Dec 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male or female subjects > 18 years of age.
- Subject has clearly visible fat on the abdomen.
- Subject has not had weight change exceeding 10 pounds in the preceding month.
- Subject agrees to maintain their weight (i.e., within 5 pounds) by not making any major changes in their diet or lifestyle during the course of the study.
- Subject has read and signed a written informed consent form.
Who cannot join
- Subject has had a surgical procedure(s) in the area of intended treatment in the past 6 months.
- Subject has had an invasive fat reduction procedure (e.g., liposuction, abdominoplasty, mesotherapy) in the area of intended treatment within the past year.
- Subject has had a non-invasive fat reduction procedure in the area of intended treatment within the past 6 months.
- Subject has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.
- Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
- Subject has a known history of Reynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
Show all 15Show fewer
- Subject has a history of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
- Subject body mass index (BMI) exceeds 40. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.
- Subject is taking or has taken diet pills or supplements within the past month.
- Subject has any dermatological conditions or scars in the location of the treatment sites that may interfere with the treatment or evaluation.
- Subject is pregnant or intending to become pregnant in the next 6 months.
- Subject is lactating or has been lactating in the past 6 months.
- 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 subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Skin Care Physicians of Chestnut Hill
Chestnut Hill, Massachusetts, 02467
Flor Mayoral, M.D.
Coral Gables, Florida, 33143
Zel Skin and Laser Specialist LLC
Edina, Minnesota, 55424
Maryland Laser, Skin and Vein Institute
Hunt Valley, Maryland, 21030
Laser and Skin Surgery of Northern California
Sacramento, California, 95816
About this study
Official title: Non-Invasive Reduction of Abdominal Fat Utilizing the JUNO Applicator
This study is being performed to reduce unwanted abdominal fat using a new applicator for the Zeltiq System.
Read the detailed description
The primary objective of the study is to achieve a discernable change to the contour of the abdominal area treated with the JUNO applicator that is consistent with that documented during a clinical study of a previous applicator used to treat lovehandles.
- Conditions
- Fat Reduction
- 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
Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Abdomen Treatment Group | Experimental | All subjects were treated on the abdomen with the CoolSculpting system. Receives: Device: The Zeltiq System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Pre-treatment Images Correctly Identified
Change in the treated vs. untreated areas will be assessed by observation of changes in surface contour and/or fat volume by an independent photo review of pre-treatment and post-treatment images of the treated areas. Reviewers will be practicing dermatologists or plastic surgeons. All reviewers will be blinded to post-treatment vs. baseline untreated area. The order in which images will be presented will be randomized; for each subject placement of the baseline, pre-treatment image will be randomized for each pair of subject images. Reviewers will be asked to select the baseline photos for each subject photo series and record selections on a data collection form. The expected success rate is an average 80% correct identification by the three reviewers.
Measured: 16 weeks
Secondary outcomes (2)
Change in the Fat Layer of the Treated Area as Measured by Ultrasound
Change in the fat layer thickness will be calculated by comparison of pre-treatment and 16 week post-treatment ultrasound measurements taken in the area treated with the device, and in the adjacent untreated control area. The Sponsor's standardized techniques for obtaining ultrasound imaging will be used. Overall fat layer thickness changes were normalized for each subject by subtracting the change in control from the change in treated area to remove the influence of weight variations. Results indicate the fat layer reduction in mm.
Measured: 16 weeks
Subject Satisfaction
Subject satisfaction with the Zeltiq procedure as determined by the results of a subjects satisfaction questionnaire at the 16 week follow up visit.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2010 (estimated)
- Study start30 Mar 2010
- Primary completion28 Sep 2010
- Study completion8 Dec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Fat ReductionStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeltiq Aesthetics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01101997
- Sponsor's protocol ID
- ZA10-001
- Acronym
- JUNO
- Status last verified
- Aug 2020
- First submitted
- 5 Apr 2010
- Last updated
- 21 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. 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
- NCT01101997
- Acronym / sponsor ID
- JUNO / ZA10-001
- Conditions
- Fat Reduction
- Keywords
- Lipolysis, Cryolipolysis, Fat Reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Zeltiq AestheticsIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2010 (actual)
- Primary completion
- 28 Sep 2010 (actual)
- Study completion
- 8 Dec 2010 (actual)
- First posted
- 12 Apr 2010 (estimated)
- Results
- Posted 21 Dec 2020
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 reduce unwanted abdominal fat using a new applicator for the Zeltiq System.
Detailed description
The primary objective of the study is to achieve a discernable change to the contour of the abdominal area treated with the JUNO applicator that is consistent with that documented during a clinical study of a previous applicator used to treat lovehandles.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Abdomen Treatment Group | Experimental | Device: The Zeltiq SystemAll subjects were treated on the abdomen with the CoolSculpting system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female subjects > 18 years of age.
- Subject has clearly visible fat on the abdomen.
- Subject has not had weight change exceeding 10 pounds in the preceding month.
- Subject agrees to maintain their weight (i.e., within 5 pounds) by not making any major changes in their diet or lifestyle during the course of the study.
- Subject has read and signed a written informed consent form.
Key exclusion criteria (15 listed)
- Subject has had a surgical procedure(s) in the area of intended treatment in the past 6 months.
- Subject has had an invasive fat reduction procedure (e.g., liposuction, abdominoplasty, mesotherapy) in the area of intended treatment within the past year.
- Subject has had a non-invasive fat reduction procedure in the area of intended treatment within the past 6 months.
- Subject has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.
- Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
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, LipolysisNoninvasive cooling is applied to the treatment area with a defined cooling rate and duration. | Device | Experimental: Abdomen Treatment Group |
Primary outcome
Proportion of Pre-treatment Images Correctly Identified
Time frame: 16 weeks
Change in the treated vs. untreated areas will be assessed by observation of changes in surface contour and/or fat volume by an independent photo review of pre-treatment and post-treatment images of the treated areas. Reviewers will be practicing dermatologists or plastic surgeons. All reviewers will be blinded to post-treatment vs. baseline untreated area. The order in which images will be presented will be randomized; for each subject placement of the baseline, pre-treatment image will be randomized for each pair of subject images. Reviewers will be asked to select the baseline photos for each subject photo series and record selections on a data collection form. The expected success rate is an average 80% correct identification by the three reviewers.
2 secondary outcomes
Change in the Fat Layer of the Treated Area as Measured by Ultrasound
Time frame: 16 weeks
Subject Satisfaction
Time frame: 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Fat Reduction
Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation Combined With Lifestyle Intervention for Visceral Fat Reduction in Adults With Overweight or Obesity
Overweight, Obesity
Not yet recruiting
Impact of Significant Surgical Reduction of Adipose Tissue on Plasma Levels and Genetic Expression of Adipokines Associated With Ischemic Heart Disease in Type I Obesity.
Obesity & Overweight, Obesity Type I and II
Not yet recruitingPhase 2
A Study to Evaluate the Efficacy, Safety, and Tolerability of CBL-514 Injection for Reducing Abdominal Subcutaneous Fat
Subcutaneous Fat
RecruitingPhase 2
A Study to Evaluate the Efficacy, Safety, and Tolerability of CBL-514 Injection for Reducing Abdominal Subcutaneous Fat
Subcutaneous Fat
Not yet recruitingPhase 3
A Study to Evaluate the Efficacy and Safety of CBL-514 Injection for Reducing Subcutaneous Fat ( SUPREME-02 )
Subcutaneous Fat
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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites 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 Fat Reduction, run by Zeltiq Aesthetics at 5 sites 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 5 inclusion and 15 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 21 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Yes. Results are posted in the registry (first posted 21 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Pre-treatment Images Correctly Identified (time frame: 16 weeks). 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 21 Dec 2020.