Reduction of Unwanted FatNCT00762437
Non-Invasive Cooling of Fat Cells
A study testing Zeltiq Dermal Cooling Device in people with Reduction of Unwanted Fat, run by Zeltiq Aesthetics at 11 sites in United States.
Trial summary
The purpose of this study is to evaluate a non-invasive cooling device to determine if cold exposure will consistently result in a reduction of subcutaneous fat. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Reduction of Unwanted Fat
- What is being tested?
- Zeltiq Dermal Cooling Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 11 sitesUnited States
- Study dates
- Jan 2008to 18 Dec 2009
- 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 an area of the body appropriate for treatment with the non-invasive Zeltiq cooling device such as the flanks, thighs, abdomen or back.
- Subject has not had weight change fluctuations exceeding 10 pounds in the preceding month and plans to maintain their weight to within ±10 pounds over the next 6 months.
- Subject has read and signed a written informed consent form.
Who cannot join
- Subject has had liposuction, or another surgical procedure(s) or mesotherapy in area of intended treatment within the past 2 years.
- Subject has a known history of subcutaneous injections into the area of intended treatment (e.g., cortisone) within the past 6 months.
- Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
- Subject has used diet pills within the past 6 months.
- Subject is unable or unwilling to comply with the study requirements.
- Subject has any dermatological conditions or scars within the location of the test sites that may interfere with the treatment or evaluation.
Show all 10Show fewer
- Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
- Patient is pregnant or intending to become pregnant in the next 9 months.
- Patient is lactating or has been lactating in the past 9 months.
- Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect response or participation in this clinical study, or would pose an unacceptable risk to the subject.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Investigational Site
Baltimore, Maryland
Investigational Site
Boston, Massachusetts
Investigational Site
Chicago, Illinois
Investigational Site
Dallas, Texas
Investigational Site
Hackensack, New Jersey
Investigational Site
Miami, Florida
Investigational Site
Minneapolis, Minnesota
Investigational Site
New York, New York
Investigational Site
Sacramento, California
Investigational Site
San Diego, California
Investigational Site
Washington D.C., District of Columbia
About this study
Official title: A Prospective Clinical Study of Non-Invasive Cooling of Subcutaneous Fat
The purpose of this study is to evaluate a non-invasive cooling device to determine if cold exposure will consistently result in a reduction of subcutaneous fat.
- Conditions
- Reduction of Unwanted Fat
- Being tested
- Zeltiq Dermal Cooling Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zeltiq Dermal Cooling DeviceDevice
Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Not described Receives: Device: Zeltiq Dermal Cooling Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Visible Improvement in Treated Area
Investigator assessment to document any visible improvement in the treatment area.
Measured: 4 months
Secondary outcomes (1)
Participant Satisfaction
Percentage satisfaction with the Zeltiq procedure as determined by the results of a subjects satisfaction questionnaire.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2008 (estimated)
- Study startJan 2008
- Primary completion17 Nov 2009
- Study completion18 Dec 2009
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 Reduction of Unwanted FatStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 175 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
- NCT00762437
- Sponsor's protocol ID
- ZA07005
- Status last verified
- May 2025
- First submitted
- 27 Sep 2008
- Last updated
- 25 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Study of Non-Invasive Cooling of Subcutaneous Fat
- ClinicalTrials.gov ID
- NCT00762437
- Acronym / sponsor ID
- ZA07005
- Conditions
- Reduction of Unwanted Fat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Zeltiq AestheticsIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- 17 Nov 2009 (actual)
- Study completion
- 18 Dec 2009 (actual)
- First posted
- 30 Sep 2008 (estimated)
- Results
- Posted 25 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate a non-invasive cooling device to determine if cold exposure will consistently result in a reduction of subcutaneous fat.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: Zeltiq Dermal Cooling Device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female subjects > 18 years of age.
- Subject has clearly visible fat on an area of the body appropriate for treatment with the non-invasive Zeltiq cooling device such as the flanks, thighs, abdomen or back.
- Subject has not had weight change fluctuations exceeding 10 pounds in the preceding month and plans to maintain their weight to within ±10 pounds over the next 6 months.
- Subject has read and signed a written informed consent form.
Key exclusion criteria (10 listed)
- Subject has had liposuction, or another surgical procedure(s) or mesotherapy in area of intended treatment within the past 2 years.
- Subject has a known history of subcutaneous injections into the area of intended treatment (e.g., cortisone) within the past 6 months.
- Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
- Subject has used diet pills within the past 6 months.
- Subject is unable or unwilling to comply with the study requirements.
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 |
|---|---|---|
| Zeltiq Dermal Cooling DeviceNon-invasive cooling is applied to the treatment area with a defined cooling rate and duration. | Device | Treatment Group |
Primary outcome
Percentage of Participants With Visible Improvement in Treated Area
Time frame: 4 months
Investigator assessment to document any visible improvement in the treatment area.
1 secondary outcome
Participant Satisfaction
Time frame: 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zeltiq Dermal Cooling Device in people with Reduction of Unwanted Fat, run by Zeltiq Aesthetics at 11 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 4 inclusion and 10 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 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 25 May 2025). 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?
Percentage of Participants With Visible Improvement in Treated Area (time frame: 4 months). 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 25 May 2025.