Body Fat DisorderNCT01600638
Non-Invasive Reduction of Fat in the Flanks of Patients With Sharp Body Curvature
A study testing The Zeltiq System in people with Body Fat Disorder, run by Zeltiq Aesthetics at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of the ZELTIQ System and the CoolCurve+ applicator for non-invasive fat reduction in flanks for a patient population with sharp body curvature. Read more about this study
- Who is it for?
- Ages 18 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
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2012to 30 Sep 2013
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female subjects > 18 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.
- Subject has not had weight change exceeding 10 pounds in the preceding month.
- Subject with body mass index (BMI) up to 29. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.
- Subject with sharp flank curvature that fits well with the CoolCurve+ applicator.
- Subject agrees to maintain his/her 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.
- Subject has had an invasive fat reduction procedure (e.g., liposuction, abdominoplasty, 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 5 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
1 site in 1 country.
United States1 site
Innovation Research Center
Pleasanton, California, 94588
About this study
The purpose of this study is to evaluate the safety and efficacy of the ZELTIQ System and the CoolCurve+ applicator for non-invasive fat reduction in flanks for a patient population with sharp body curvature.
Read the detailed description
The Zeltiq System with the CoolCurve+ applicator will be evaluated for safety and effectiveness in subjects with subcutaneous fat on the flanks and who have sharp body curvatures. The curvature of interest is typical of individuals who are relatively thin with a small body frame.
- 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
Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
| Study group | Role | What they receive |
|---|---|---|
| Zeltiq System Treatment Group | Experimental | Individuals with sharp flank curvatures were treated on one (1) flank with the Zeltiq CoolSculpting System and the CoolCurve+ applicator at protocol-defined temperatures and durations. Receives: Device: The Zeltiq System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the Zeltiq System for Non-invasive Fat Reduction in Subjects With Greater Flank Curvature.
Safety will be assessed by determination of the number of Unanticipated Adverse Device Effects (UADE) at the 8-week and 16-week post-treatment visits.
Measured: 8 weeks and 16 weeks post final treatment
Change in Fat Layer Thickness When Compared to Untreated Control
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 contralateral 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 the untreated control from the change in treated area to remove the influence of weight variations. Results indicate the mm of fat layer reduction in the treated area.
Measured: 16 weeks post final treatment
Secondary outcomes (3)
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. Results reflect the proportion of correctly identified images.
Measured: 16 weeks post final treatment
Subject Satisfaction Questionnaire
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 post final treatment
Additional Safety Evaluation
The number of device or procedure-related adverse events will be evaluated. The investigator determines if the Zeltiq CoolSculpting System (device) or the treatment (procedure) are related to all reported adverse events.
Measured: Enrollment though 16 weeks post final treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2012 (estimated)
- Study start29 Mar 2012
- Primary completion29 Aug 2012
- Study completion30 Sep 2013
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 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeltiq Aesthetics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Bachelor, MD, Principal investigator, Innovation Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01600638
- Sponsor's protocol ID
- ZA12-005
- Status last verified
- Oct 2020
- First submitted
- 16 Apr 2012
- Last updated
- 26 Oct 2020
- 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 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Reduction of Fat in the Flanks of Patients With Sharp Body Curvature
- ClinicalTrials.gov ID
- NCT01600638
- Acronym / sponsor ID
- ZA12-005
- Conditions
- Body Fat Disorder
- Keywords
- Lipolysis, Cryolipolysis, Fat Reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Zeltiq AestheticsIndustry (pharma, biotech, devices)
- Study start
- 29 Mar 2012 (actual)
- Primary completion
- 29 Aug 2012 (actual)
- Study completion
- 30 Sep 2013 (actual)
- First posted
- 17 May 2012 (estimated)
- Results
- Posted 26 Oct 2020
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 the safety and efficacy of the ZELTIQ System and the CoolCurve+ applicator for non-invasive fat reduction in flanks for a patient population with sharp body curvature.
Detailed description
The Zeltiq System with the CoolCurve+ applicator will be evaluated for safety and effectiveness in subjects with subcutaneous fat on the flanks and who have sharp body curvatures. The curvature of interest is typical of individuals who are relatively thin with a small body frame.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zeltiq System Treatment Group | Experimental | Device: The Zeltiq SystemIndividuals with sharp flank curvatures were treated on one (1) flank with the Zeltiq CoolSculpting System and the CoolCurve+ applicator at protocol-defined temperatures and durations. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female subjects > 18 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.
- Subject has not had weight change exceeding 10 pounds in the preceding month.
- Subject with body mass index (BMI) up to 29. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.
- Subject with sharp flank curvature that fits well with the CoolCurve+ applicator.
Key exclusion criteria (15 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, abdominoplasty, 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 SystemAlso: Cryolipolysis, LipolysisNon-invasive cooling is applied to the treatment area with a defined cooling rate and duration. | Device | Zeltiq System Treatment Group |
Primary outcome
Safety of the Zeltiq System for Non-invasive Fat Reduction in Subjects With Greater Flank Curvature.
Time frame: 8 weeks and 16 weeks post final treatment
Safety will be assessed by determination of the number of Unanticipated Adverse Device Effects (UADE) at the 8-week and 16-week post-treatment visits.
Change in Fat Layer Thickness When Compared to Untreated Control
Time frame: 16 weeks post final treatment
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 contralateral 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 the untreated control from the change in treated area to remove the influence of weight variations. Results indicate the mm of fat layer reduction in the treated area.
3 secondary outcomes
Proportion of Pre-treatment Images Correctly Identified
Time frame: 16 weeks post final treatment
Subject Satisfaction Questionnaire
Time frame: 16 weeks post final treatment
Additional Safety Evaluation
Time frame: Enrollment though 16 weeks post final treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2020.
- 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.
Eric Bachelor, MD principal investigator
Innovation Research Center
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 7 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 26 Oct 2020. 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?
Yes. Results are posted in the registry (first posted 26 Oct 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?
Safety of the Zeltiq System for Non-invasive Fat Reduction in Subjects With Greater Flank Curvature. (time frame: 8 weeks and 16 weeks post final treatment). 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 26 Oct 2020.