CompletedNCT02324816Updated Dec 28, 2021Results posted

Fat Layer Reduction in the Lateral Thighs Using CoolSculpting

An interventional study of The Zeltiq CoolSculpting System in Body Fat Disorder, sponsored by Zeltiq Aesthetics. Completed at 1 site in United States. Open to participants aged 22 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-28.

Sponsored by Zeltiq Aesthetics · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 19
Allocation: Not applicable
Ages: 22 Years to 65 Years
Sex: All

Study summary

Evaluate the performance of a cryolipolysis system using a colder treatment parameter for non-invasive reduction of subcutaneous fat in the lateral thighs.

Read the detailed description

Evaluation of the Zeltiq CoolSculpting System for non-invasive subcutaneous fat reduction in the lateral thighs.

Conditions studied

Body Fat Disorder

Browse trials for

Lipid Metabolism Disorders 180

In context

Lipid Metabolism Disorders

180 studies on the registry are indexed under Lipid Metabolism Disorders; 33 are open to participants now.

This study's enrollment of 19 is below the median of 51 across 136 interventional studies indexed under Lipid Metabolism Disorders.

Browse Lipid Metabolism Disorders studies →

Lead sponsor

Zeltiq Aesthetics is the lead sponsor of 39 studies on the registry; none are open to participants now.

Of its 29 completed or terminated interventional studies of FDA-regulated products, 29 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 22 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Male or female subjects > 22 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 35. 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 a written informed consent form.

Exclusion criteria

Exclusion Criteria:

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 4 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.
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 4 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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 19 participants (actual)

Study arms

Experimental
Lateral Thigh Treatment Group
CoolSculpting treatment in the lateral thighs for non-invasive subcutaneous fat reduction.
Device: The Zeltiq CoolSculpting System

Interventions

DeviceThe Zeltiq CoolSculpting System
The CoolSculpting System delivers non-invasive cooling for the reduction of subcutaneous fat.

What researchers measure

Primary outcomes

Safety of the Zeltiq CoolSculpting System in the Outer Thighs
Tabulation of device and/or procedure-related adverse events and unanticipated adverse device effects will be performed. Adverse event information will be collected from the time of study enrollment through the 12 week follow-up visit. The Investigator will determine if an adverse event is related to the device and/or study procedure.
Time frame: Enrollment through 12 week post-final treatment follow-up visit

Secondary outcomes

Percentage of Correctly Identified Pre-treatment Photographs
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. Success is defined as at least 70% correct identification of pre-treatment images by 2 out of 3 reviewers.
Time frame: 12 weeks post-final treatment

Results

Posted Sep 24, 2020

Participant flow

Participant flow — Overall Study
Milestone	Lateral Thigh Treatment Group
Started	19
Completed	19
Not completed	0

Outcome measures

PrimarySafety of the Zeltiq CoolSculpting System in the Outer Thighs

Tabulation of device and/or procedure-related adverse events and unanticipated adverse device effects will be performed. Adverse event information will be collected from the time of study enrollment through the 12 week follow-up visit. The Investigator will determine if an adverse event is related to the device and/or study procedure.

Time frame:: Enrollment through 12 week post-final treatment follow-up visit
Reported as:: Number · events

Safety of the Zeltiq CoolSculpting System in the Outer Thighs
events	Lateral Thigh Treatment Group
Device and/or procedure related AEs	8
UADEs reported	0

SecondaryPercentage of Correctly Identified Pre-treatment Photographs

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. Success is defined as at least 70% correct identification of pre-treatment images by 2 out of 3 reviewers.

Time frame:: 12 weeks post-final treatment
Reported as:: Count of units · photo pairs

Percentage of Correctly Identified Pre-treatment Photographs
photo pairs	Lateral Thigh Treatment Group
Percentage of Correctly Identified Pre-treatment Photographs	14

Statistical analysis

Lateral Thigh Treatment Group · Success proportion: 73.7 · 95% CI 48.8 to 90.9

Adverse events

Collected over Adverse event data were collected from enrollment through the 12-week post-treatment follow-up visit.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Lateral Thigh Treatment Group	0/19 (0%)	0/19 (0%)	14/19 (73.7%)

Most frequent other events

Most frequent other events
Event	Lateral Thigh Treatment Group
Prolonged swellingSkin and subcutaneous tissue disorders	4/19
Prolonged bruisingSkin and subcutaneous tissue disorders	2/19
Erythema lasting > 2 weeksSkin and subcutaneous tissue disorders	2/19
Cold with coughRespiratory, thoracic and mediastinal disorders	1/19
24 hour coldGeneral disorders	1/19
Rotator cuff pin adjustmentSurgical and medical procedures	1/19
Tendonitis flare upMusculoskeletal and connective tissue disorders	1/19
EczemaSkin and subcutaneous tissue disorders	1/19
Menopausal changesReproductive system and breast disorders	1/19

Baseline characteristics

Female subjects with visible fat bulges on the outer thighs were recruited for the study.

Age, Categorical
Age, Categorical(Participants)	Lateral Thigh Treatment Group
<=18 years	0
Between 18 and 65 years	19
>=65 years	0

Age, Continuous
Age, Continuous(years)	Lateral Thigh Treatment Group
Mean	45.0 (31 to 59)

Sex: Female, Male
Sex: Female, Male(Participants)	Lateral Thigh Treatment Group
Female	19
Male	0

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Lateral Thigh Treatment Group
African American	0
Asian	2
Caucasian	16
Hispanic	0
Others	1

Region of Enrollment
Region of Enrollment(participants)	Lateral Thigh Treatment Group
United States	19

Body Mass Index
Body Mass Index(kg//m^2^)	Lateral Thigh Treatment Group
Mean	26.5 (21 to 32.1)

Study locations

1 site

Innovation Research Center
Pleasanton, California 94588, United States

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02324816
Lead sponsor: Zeltiq Aesthetics
Responsible party: Sponsor
First posted: Dec 24, 2014
Start date: Nov 14, 2014
Primary completion: Mar 13, 2015
Completion: Mar 31, 2015
Results posted: Sep 24, 2020
Last update: Dec 28, 2021

Study contacts

Eric Bachelor, MD

principal investigator · Innovation Research Center

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Lipid Metabolism Disorders→

Other studies from this sponsor

Zeltiq Aesthetics

Start the discussion