Body Fat DisorderNCT02081209

Outer Thigh Study With Varied Treatment Parameters

A study testing The Zeltiq CoolSculpting System in people with Body Fat Disorder, run by Zeltiq Aesthetics at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to compare the performance of the Zeltiq CoolSculpting System using various treatment parameters for non-invasive reduction of subcutaneous fat in the lateral thighs. 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 CoolSculpting System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 2 sitesUnited States
Study dates: 4 Feb 2014to 21 Oct 2014
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 intended treatment area (lateral thighs), 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 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 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, 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 2 months.
Subject has significant asymmetry between the lateral thighs.
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.

Show all 16Show fewer

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.
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

2 sites in 1 country.

United States2 sites

Marina Plastic Surgery
Marina del Rey, California, 90292
Innovation Research Center
Pleasanton, California, 94588

Other trials in United States

About this study

Official title: Non-Invasive Fat Layer Reduction in the Lateral Thighs With a Cryolipolysis System Using Varied Treatment Parameters

The purpose of this study is to compare the performance of the Zeltiq CoolSculpting System using various treatment parameters for non-invasive reduction of subcutaneous fat in the lateral thighs.

Read the detailed description

The purpose of this study is to compare the performance of a cryolipolysis system using various treatment parameters for non-invasive reduction of subcutaneous fat in the lateral thighs.

Conditions: Body Fat Disorder
Being tested: The Zeltiq CoolSculpting 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 CoolSculpting SystemDevice
Also called Cryolipolysis
Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.

Study groups in NCT02081209
Study group	Role	What they receive
Lateral Thigh Treatment Group	Experimental	All subjects were treated on both thighs with the CoolSculpting System. One lateral thigh was treated using a protocol-defined temperature for 120 minutes. The contralateral thigh was treated at a protocol defined temperature for 60 minutes for 18 subjects. Twenty-two subjects were treated on the contralateral outer thigh with a 3rd protocol-defined temperature for 60 minutes. Receives: Device: The Zeltiq CoolSculpting System

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety of the Zeltiq Device
The number of device- or procedure-related adverse events will be tabulated from the time of enrollment through the 16 week follow-up visit.
Measured: Time of enrollment though16 weeks post-treatment (approximately 5 months)
Safety of the Zeltiq Device
The number of unanticipated adverse device effects (UADEs) will be tabulated.
Measured: From enrollment through 16 week follow-up (approximately 5 months)
Percentage 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. Criteria for evaluable photos for the purposes of the independent review: subject completed treatment regimen; subject has complete set of baseline photos; subject has a complete set of post-treatment photos; photos were taken using Zeltiq standard procedure. The expected success rate is 80%.
Measured: Baseline and 16 weeks post-treatment

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 (untreated area) from the change in treated area to remove the influence of weight variations. Success is defined as, on average, at least a 1mm or greater reduction in fat layer thickness for the treated region as compared to the untreated control. Results indicate the mean fat layer reduction in mm.
Measured: 16 weeks post-treatment
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. The questionnaire is composed of a 5-point Likert scale questions, as well as free text responses. Subjects will be asked to determine overall satisfaction with the treatment. The choices will be 1) very unsatisfied; 2) somewhat unsatisfied; 3) neither unsatisfied or satisfied; 4) somewhat satisfied; 5) very satisfied.
Measured: 16-weeks post treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Feb 201421 Oct 2014

First posted7 Mar 2014 (estimated)
Study start4 Feb 2014
Primary completion21 Oct 2014
Study completion21 Oct 2014

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: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: All subjects to be treated on one lateral thigh at a protocol-defined temperature for 120 minutes. Treatment of the contralateral thigh was performed using two unique protocol-defined temperatures for 60 minutes.
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02081209
Sponsor's protocol ID: ZA14-001
Status last verified: May 2025
First submitted: 4 Mar 2014
Last updated: 21 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Non-Invasive Fat Layer Reduction in the Lateral Thighs With a Cryolipolysis System Using Varied Treatment Parameters
ClinicalTrials.gov ID: NCT02081209
Acronym / sponsor ID: ZA14-001
Conditions: Body Fat Disorder
Keywords: Lipolysis, Cryolipolysis, Fat Reduction
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Zeltiq AestheticsIndustry (pharma, biotech, devices)
Study start: 4 Feb 2014 (actual)
Primary completion: 21 Oct 2014 (actual)
Study completion: 21 Oct 2014 (actual)
First posted: 7 Mar 2014 (estimated)
Results: Posted 21 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 compare the performance of the Zeltiq CoolSculpting System using various treatment parameters for non-invasive reduction of subcutaneous fat in the lateral thighs.

Detailed description

The purpose of this study is to compare the performance of a cryolipolysis system using various treatment parameters for non-invasive reduction of subcutaneous fat in the lateral thighs.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: All subjects to be treated on one lateral thigh at a protocol-defined temperature for 120 minutes. Treatment of the contralateral thigh was performed using two unique protocol-defined temperatures for 60 minutes.

Arm	Type	Receives
Lateral Thigh Treatment Group	Experimental	Device: The Zeltiq CoolSculpting SystemAll subjects were treated on both thighs with the CoolSculpting System. One lateral thigh was treated using a protocol-defined temperature for 120 minutes. The contralateral thigh was treated at a protocol defined temperature for 60 minutes for 18 subjects. Twenty-two subjects were treated on the contralateral outer thigh with a 3rd protocol-defined temperature for 60 minutes.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Male or female subjects > 18 years of age and < 65 years of age.
Subject has clearly visible fat on the intended treatment area (lateral thighs), 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 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 pounds) by not making any major changes in their diet or lifestyle 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 2 months.
Subject has significant asymmetry between the lateral thighs.
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.

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 CoolSculpting SystemAlso: CryolipolysisNon-invasive cooling is applied to the treatment area with a defined cooling rate and duration.	Device	Lateral Thigh Treatment Group

Primary outcome

Safety of the Zeltiq Device
Time frame: Time of enrollment though16 weeks post-treatment (approximately 5 months)
The number of device- or procedure-related adverse events will be tabulated from the time of enrollment through the 16 week follow-up visit.
Safety of the Zeltiq Device
Time frame: From enrollment through 16 week follow-up (approximately 5 months)
The number of unanticipated adverse device effects (UADEs) will be tabulated.
Percentage of Pre-treatment Images Correctly Identified.
Time frame: Baseline and 16 weeks post-treatment
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. Criteria for evaluable photos for the purposes of the independent review: subject completed treatment regimen; subject has complete set of baseline photos; subject has a complete set of post-treatment photos; photos were taken using Zeltiq standard procedure. The expected success rate is 80%.

2 secondary outcomes

Change in the Fat Layer of the Treated Area as Measured by Ultrasound
Time frame: 16 weeks post-treatment
Subject Satisfaction
Time frame: 16-weeks post treatment

Results and safety

Results posted to the registry on 21 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lateral Thigh Treatment Group	40	39

Primary outcome: Safety of the Zeltiq Device

Time frame: Time of enrollment though16 weeks post-treatment (approximately 5 months). Number. Unit: device/procedure related AEs

Measure	Lateral Thigh Treatment Parameter: -10C n = 40	Contralateral Thigh Treatment Parameter: -13C n = 18	Contralateral Thigh Treatment Parameter:-15C n = 22
Value	7	4	12

Population analysed: All subjects treated with the Zeltiq CoolSculpting System were included in the analysis population.

Primary outcome: Safety of the Zeltiq Device

Time frame: From enrollment through 16 week follow-up (approximately 5 months). Number. Unit: UADEs reported

Measure	Lateral Thigh Treatment Parameter: -10C n = 40	Contralateral Thigh Treatment Parameter: -13C n = 18	Contralateral Thigh Treatment Parameter:-15C n = 22
Value	0	0	0

Population analysed: All subjects treated with the Zeltiq CoolSculpting System were included in the analysis population.

Primary outcome: Percentage of Pre-treatment Images Correctly Identified.

Time frame: Baseline and 16 weeks post-treatment. Count of units. Unit: photos

Measure	All Subjects Both Outer Thighs n = 34	Lateral Thigh Treatment Group-All Subjects n = 34	Group 1: Contralateral Outer Thigh Treatment 2 n = 16	Contralateral Outer Thigh Treatment Group 3 n = 18
Value	168	79	38	51

All Subjects Both Outer Thighs: sucess percentage: 82.4 (95% CI 76.4 to 87.3)
Lateral Thigh Treatment Group-All Subjects: sucess percentage: 77.4 (95% CI 68.1 to 85.1)
Group 1: Contralateral Outer Thigh Treatment 2: sucess percentage: 79.2 (95% CI 65.0 to 89.5)

Population analysed: The per-protocol analysis population included subjects with available photos and complied with protocol-defined weight maintenance. Thirty-four subjects had 68 photo pairs which were presented to three blinded physician reviewers.Of the 37 subjects with available photos, 3 subjects were excluded due to weight change outside of protocol requirements.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected from the time of enrollment through the 16-week follow-up visit, approximately 5 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lateral Thigh Treatment Parameter: -10C	0 of 40 (0%)	17 of 40 (42.5%)	0 of 40
Contralateral Thigh Treatment Parameter: -13C	0 of 18 (0%)	6 of 18 (33.3%)	0 of 18
Contralateral Thigh Treatment Parameter:-15C	0 of 22 (0%)	20 of 22 (90.9%)	0 of 22

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 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.

Eric Bachelor, MD principal investigator

Innovation Research Center

2 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 CoolSculpting System in people with Body Fat Disorder, run by Zeltiq Aesthetics at 2 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: finished, as of the sponsor's last update on 21 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 2 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 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?

Safety of the Zeltiq Device (time frame: Time of enrollment though16 weeks post-treatment (approximately 5 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02081209.

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 May 2025.