Fat DisorderNCT00762307

Non-invasive Cooling of Subcutaneous Fat

A study testing Zeltiq Dermal Cooling Device in people with Fat Disorder, run by Zeltiq Aesthetics at 4 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 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: Fat Disorder
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: 60 participants
Where: 4 sitesUnited States
Study dates: Jan 2007to Jan 2012
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 the flanks, thighs, abdomen, or back.
Subject has not had weight change fluctuations exceeding 10 pounds in the preceding month.
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 is taking 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

4 sites in 1 country.

United States4 sites

Investigational Site
Dublin, California
Investigational Site
Fremont, California
Investigational Site
Pleasanton, California
Investigational Site
San Ramon, California

Other trials in United States

About this study

Official title: A Prospective, Multi-Center 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.

Read the detailed description

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 using the Zeltiq Dermal Cooling device.

Conditions: Fat Disorder
Being tested: Zeltiq Dermal Cooling Device
Medical subject headings: Lipid Metabolism Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Zeltiq Dermal Cooling DeviceDevice
Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration.

Study groups in NCT00762307
Study group	Role	What they receive
Treatment Group 1	Experimental	Cooling Intensity Factor = 33 Duration = 60 minutes Receives: Device: Zeltiq Dermal Cooling Device
Treatment Group 2	Experimental	Cooling Intensity Factor = 37 Duration = 30 minutes Receives: Device: Zeltiq Dermal Cooling Device
Treatment Group 3	Experimental	Cooling Intensity Factor = 37 Duration = 45 minutes Receives: Device: Zeltiq Dermal Cooling Device
Treatment Group 4	Experimental	Cooling Intensity Factor = 42 Cooling Duration = 30 minutes Receives: Device: Zeltiq Dermal Cooling Device

What is being measured

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

Change in Fat Layer Thickness of the Treated Flank
The change in fat layer thickness as demonstrated by measurement of fat layer layer thickness using ultrasound images taken in the treated area and on the contralateral flank (control) at baseline and at the 6 month follow-up. Data collected on the untreated side and the treated side will be combined to determine the normalized change in fat layer thickness for each subject. The mean percent fat layer reduction across all treatment groups will be presented, as well as for each treatment group.
Measured: Baseline and 6 months
Percentage of Subjects Expressing Satisfaction With the Procedure
Subject satisfaction as determined by the completion of a questionnaire at the 6 month follow-up visit, and, as requested, any other follow-up visits.
Measured: 6 months post-treatment follow-up visit
Percentage of Correctly Identified Pre-treatment Photographs
Change in the treated vs. untreated areas will be assessed for changes in surface contour and/or fat volume by an independent photo review of pre-treatment and post-treatment images of the control and treated flanks. Reviewers will be practicing dermatologists. All reviewers will be blinded to post-treatment vs. baseline and/or untreated flank. 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. Results reflect the percentage of correctly identified images.
Measured: Baseline and 6 months

Timeline

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

Jan 2007Jan 2012

First posted30 Sep 2008 (estimated)
Study startJan 2007
Primary completionJan 2012
Study completionJan 2012

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 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00762307
Sponsor's protocol ID: JM07001
Status last verified: Sep 2020
First submitted: 27 Sep 2008
Last updated: 9 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

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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All Fat Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multi-Center Clinical Study of Non-Invasive Cooling of Subcutaneous Fat
ClinicalTrials.gov ID: NCT00762307
Acronym / sponsor ID: JM07001
Conditions: Fat Disorder
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Zeltiq AestheticsIndustry (pharma, biotech, devices)
Study start: Jan 2007
Primary completion: Jan 2012 (actual)
Study completion: Jan 2012 (actual)
First posted: 30 Sep 2008 (estimated)
Results: Posted 9 Jun 2021

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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Treatment Group 1	Experimental	Device: Zeltiq Dermal Cooling DeviceCooling Intensity Factor = 33 Duration = 60 minutes
Treatment Group 2	Experimental	Device: Zeltiq Dermal Cooling DeviceCooling Intensity Factor = 37 Duration = 30 minutes
Treatment Group 3	Experimental	Device: Zeltiq Dermal Cooling DeviceCooling Intensity Factor = 37 Duration = 45 minutes
Treatment Group 4	Experimental	Device: Zeltiq Dermal Cooling DeviceCooling Intensity Factor = 42 Cooling Duration = 30 minutes

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 the flanks, thighs, abdomen, or back.
Subject has not had weight change fluctuations exceeding 10 pounds in the preceding month.
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 is taking 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 DeviceNoninvasive cooling is applied to the treatment area with a defined cooling rate and duration.	Device	Treatment Group 1, Treatment Group 2, Treatment Group 3, Treatment Group 4

Primary outcome

Change in Fat Layer Thickness of the Treated Flank
Time frame: Baseline and 6 months
The change in fat layer thickness as demonstrated by measurement of fat layer layer thickness using ultrasound images taken in the treated area and on the contralateral flank (control) at baseline and at the 6 month follow-up. Data collected on the untreated side and the treated side will be combined to determine the normalized change in fat layer thickness for each subject. The mean percent fat layer reduction across all treatment groups will be presented, as well as for each treatment group.
Percentage of Subjects Expressing Satisfaction With the Procedure
Time frame: 6 months post-treatment follow-up visit
Subject satisfaction as determined by the completion of a questionnaire at the 6 month follow-up visit, and, as requested, any other follow-up visits.
Percentage of Correctly Identified Pre-treatment Photographs
Time frame: Baseline and 6 months
Change in the treated vs. untreated areas will be assessed for changes in surface contour and/or fat volume by an independent photo review of pre-treatment and post-treatment images of the control and treated flanks. Reviewers will be practicing dermatologists. All reviewers will be blinded to post-treatment vs. baseline and/or untreated flank. 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. Results reflect the percentage of correctly identified images.

Results and safety

Results posted to the registry on 9 Jun 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Group 1	28	26
Treatment Group 2	11	11
Treatment Group 3	11	11
Treatment Group 4	10	9

Primary outcome: Change in Fat Layer Thickness of the Treated Flank

Time frame: Baseline and 6 months. Mean (Standard Error). Unit: percent fat layer change

Measure	All Groups n = 46	Group 1 n = 20	Group 2 n = 10	Group 3 n = 8	Group 4 n = 8
Value	-18.7 (1.9)	-22.6 (3.4)	-17.8 (3.6)	-17.5 (2.3)	-11.1 (3.8)

All Groups: Mean Difference (Net): 18.7 (95% CI 14.9 to 22.4)

Population analysed: The population includes only subjects with evaluable ultrasound data ( \>3 valid images at 6 month follow up visit). Group 1 exclusions: 2 Lost To Follow Up and 6 not evaluable; Group 2 exclusions: 1 not evaluable; Group 3 exclusions: 3 not evaluable; Group 4 exclusions: 1 not evaluable and 1 withdrawn from study by Investigator.

Primary outcome: Percentage of Subjects Expressing Satisfaction With the Procedure

Time frame: 6 months post-treatment follow-up visit. Mean (Standard Deviation). Unit: percent positive responses

Measure	Overall Study Population n = 56	Treatment Group 1 n = 25	Treatment Group 2 n = 11	Treatment Group 3 n = 11	Treatment Group 4 n = 9
Overall satisfaction with treatment experience	82.1 (5.1)	84 (7.3)	81.8 (11.6)	90.9 (8.7)	66.7 (15.7)
Agree there is a change to the treated area	76.3 (5.7)	84 (7.3)	54.5 (15.0)	100 (0)	55.6 (16.6)
Agree change to treated area was improvement	78.9 (5.7)	95.2 (4.7)	63.6 (14.5)	81.8 (11.6)	55.6 (16.6)
Expectations were met or exceeded	73.2 (5.9)	72 (9.0)	78.6 (12.4)	81.8 (11.6)	66.7 (15.7)
Discomfort was no greater than expected	98.2 (1.8)	100 (0)	90.9 (8.7)	100 (0)	100 (0)

Population analysed: 56 subjects completed the questionnaire; 2 subjects were LTFU, 1 subject failed to complete the questionnaire and 1 subject was withdrawn from the study by the Investigator. Four (4) subjects did not respond to one question on the questionnaire; 1 subject did not respond to another question on the questionnaire.

Primary outcome: Percentage of Correctly Identified Pre-treatment Photographs

Time frame: Baseline and 6 months. Mean (Standard Error). Unit: percent correctly identified images

Measure	All Groups n = 31	Treatment Group 1 n = 11	Treatment Group 2 n = 8	Treatment Group 3 n = 6	Treatment Group 4 n = 6
Value	91.9 (5.2)	90.5 (7.6)	100 (0)	100 (0)	83.3 (15.2)

All Groups: sucess percentage: 91.9

Population analysed: The analysis population included subjects who had evaluable photos from baseline and the 6 month final follow-up visit. Subjects who did not maintain their weight per protocol requirements were excluded from analysis.

Adverse events

Time frame: Adverse event data were collected from the time of enrollment though the 6 month follow-up visit, a time period of approximately 8 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment Group 1	0 of 28 (0%)	1 of 28 (3.6%)	0 of 28
Treatment Group 2	0 of 11 (0%)	1 of 11 (9.1%)	0 of 11
Treatment Group 3	0 of 11 (0%)	1 of 11 (9.1%)	0 of 11
Treatment Group 4	0 of 10 (0%)	1 of 10 (10%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Fat Disorder

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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 study chair

Zeltiq Aesthetics

4 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 Fat Disorder, run by Zeltiq Aesthetics at 4 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 9 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 9 Jun 2021). 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?

Change in Fat Layer Thickness of the Treated Flank (time frame: Baseline and 6 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 NCT00762307.

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 9 Jun 2021.