Body Fat DisorderCSINCT03304925
CoolSculpting the Flanks
A study testing The ZELTIQ System in people with Body Fat Disorder, run by Zeltiq Aesthetics at 7 sites in United States.
Trial summary
Evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction in the flanks. Read more about this study
- Who is it for?
- Ages 22 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Fat Disorder
- 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
- 320 participants
- Where
- 7 sitesUnited States
- Study dates
- 25 Oct 2017to Aug 2022
- 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 22 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female subjects > 22 years of age and < 65 years of age.
- Subject has clearly visible fat on the flanks, which in the investigator's opinion, may benefit from the treatment.
- No weight change exceeding 5% of body weight in the preceding month.
- Subject with body mass index (BMI) up to 30. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.
- Subject agrees to maintain his/her weight (i.e., within 5%) by not making any major changes in their diet or exercise routine during the course of the study.
- Subject has read and signed the study written informed consent form.
Who cannot join
- Subject has had a surgical procedure(s) in the area of intended treatment.
- Subject has had an invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the area of intended treatment.
- Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 12 months.
- Subject needs to administer, or 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 Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
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- 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 is taking or has taken diet pills or supplements within the past month.
- Subject has any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites that may interfere with the treatment or evaluation (stretch marks is not an exclusion).
- Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system
- Subject is pregnant or intending to become pregnant during the study period (in the next 8 months).
- Subject is lactating or has been lactating in the past 6 months.
- Subject has a history of hernia in the areas to be treated.
- 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
7 sites in 1 country.
7 sites in 1 country
United States7 sites
SkinCare Physicians of Chestnut Hill
Chestnut Hill, Massachusetts, 02467
EpiCenter Skincare and Laser Center
Dallas, Texas, 95231
Zel Skin & Laser Specialist
Edina, Minnesota, 55424
Brian S. Biesman, MD
Nashville, Tennessee, 37203
Laser & Skin Surgery Center of New York
New York, New York, 10016
Innovation Research Center
Pleasanton, California, 94588
Laser & Skin Surgery Center of Northern California
Sacramento, California, 95816
About this study
Evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction in the flanks.
- Conditions
- Body Fat Disorder
- Being tested
- The ZELTIQ System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The ZELTIQ SystemDevice
The CoolSculpting machine will be used to perform the treatments.
| Study group | Role | What they receive |
|---|---|---|
| Fat Reduction | Experimental | The treatments are designed to see if the fat can be reduced in the flanks with a new applicator design. Receives: Device: The ZELTIQ System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety endpoint in relation to adverse events
Measurement of device- or procedure-related adverse events. It is expected there will be zero UADEs
Measured: Final post treatment visit
Effectiveness endpoint gauged by reduction in fat layer thickness
Reduction in fat layer thickness as measured by ultrasound at the final post-treatment visit.
Measured: Final post-treatment visit
Secondary outcomes (2)
Subject survey
Subject survey as assessed by questionnaire administered at the final post-treatment visit.
Measured: Final post-treatment visit
Photo review
Correct identification of pre-treatment vs. final post-treatment visit images by two out of three blinded independent reviewers.
Measured: Final post-treatment visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2017
- Study start25 Oct 2017
- Primary completionAug 2022 (estimated)
- Study completionAug 2022 (estimated)
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
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zeltiq Aesthetics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kerrie Jiang, NP, Study director, Zeltiq Aesthetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03304925
- Sponsor's protocol ID
- ZA17-002
- Acronym
- CSI
- Status last verified
- Aug 2020
- First submitted
- 3 Oct 2017
- Last updated
- 18 Aug 2020
- Results posted
- No
- 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 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CoolSculpting the Flanks
- ClinicalTrials.gov ID
- NCT03304925
- Acronym / sponsor ID
- CSI / ZA17-002
- Conditions
- Body Fat Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Zeltiq AestheticsIndustry (pharma, biotech, devices)
- Study start
- 25 Oct 2017 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 9 Oct 2017 (actual)
- 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.
Evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction in the flanks.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fat Reduction | Experimental | Device: The ZELTIQ SystemThe treatments are designed to see if the fat can be reduced in the flanks with a new applicator design. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female subjects > 22 years of age and < 65 years of age.
- Subject has clearly visible fat on the flanks, which in the investigator's opinion, may benefit from the treatment.
- No weight change exceeding 5% of body weight in the preceding month.
- Subject with body mass index (BMI) up to 30. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.
- Subject agrees to maintain his/her weight (i.e., within 5%) by not making any major changes in their diet or exercise routine during the course of the study.
Key exclusion criteria (16 listed)
- Subject has had a surgical procedure(s) in the area of intended treatment.
- Subject has had an invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the area of intended treatment.
- Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 12 months.
- Subject needs to administer, or 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 SystemThe CoolSculpting machine will be used to perform the treatments. | Device | Fat Reduction |
Primary outcome
Safety endpoint in relation to adverse events
Time frame: Final post treatment visit
Measurement of device- or procedure-related adverse events. It is expected there will be zero UADEs
Effectiveness endpoint gauged by reduction in fat layer thickness
Time frame: Final post-treatment visit
Reduction in fat layer thickness as measured by ultrasound at the final post-treatment visit.
2 secondary outcomes
Subject survey
Time frame: Final post-treatment visit
Photo review
Time frame: Final post-treatment visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
- 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.
Kerrie Jiang, NP study director
Zeltiq Aesthetics
7 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 Body Fat Disorder, run by Zeltiq Aesthetics at 7 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 6 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 18 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Results are not available in the source record.
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?
Safety endpoint in relation to adverse events (time frame: Final post treatment visit). The study lists 2 primary outcomes in all. 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 18 Aug 2020.