Body Fat DisorderTOPSNCT01728857

Tissue Optimization on Cryolipolysis Procedures for Fat Layer Reduction

A study testing The Zeltiq System in people with Body Fat Disorder, run by Zeltiq Aesthetics at 1 site 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

Evaluate the effects of tissue optimization before and during cryolipolysis procedures on the outcome of non-invasive fat reduction using the ZELTIQ System. 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: 19 participants
Where: 1 siteUnited States
Study dates: Nov 2012to 10 Mar 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 intended treatment area, which in the investigator's opinion, may benefit from the treatment(s).
Subject has not had weight change exceeding 10 pounds in the preceding month.
Subject with body mass index (BMI) less than 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 presents a significant asymmetry of intended treatment areas.
Subject has had a surgical procedure(s) in the area of intended treatment in the past 5 years.
Subject has had an invasive fat reduction procedure (e.g., liposuction, abdominoplasty, mesotherapy) in the area of intended treatment in the past 5 years.
Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 6 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.

Show all 17Show 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 weight control 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 in the next 5 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

1 site in 1 country.

United States1 site

Innovation Research Center
Pleasanton, California, 94588

Other trials in United States

About this study

Official title: The Effects of Tissue Optimization on Cryolipolysis Procedures for Fat Layer Reduction

Evaluate the effects of tissue optimization before and during cryolipolysis procedures on the outcome of non-invasive fat reduction using the ZELTIQ System.

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 groups in NCT01728857
Study group	Role	What they receive
Fat Reduction	Experimental	Not described Receives: Device: The Zeltiq System

What is being measured

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

Percentage of Before and After Side-by-side Photographs Correctly Identified by At Least 2 of 3 Blinded Reviewers From the Independent Physician Reviewer (IPR) Panel
Photographs of the treatment areas were taken at baseline, and at 16-weeks after the first treatment with the ZELTIQ System were assessed for any visual changes. The photographs were assessed by blinded independent reviewers (IPR) to correctly identify the 16-weeks post-treatment photographs from randomly placed side-by-side comparison of before and after photographs. Reported here is the percentage (%) of images that were correctly identified by at least 2 out of 3 blinded independent reviewers.
Measured: Baseline, Week 16

Secondary outcomes (1)

Change From Baseline in Reduction of Fat Layer Thickness as Assessed by Ultrasound
Measured: Baseline, Week 16

Timeline

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

Nov 201210 Mar 2014

First posted20 Nov 2012 (estimated)
Study startNov 2012
Primary completion10 Mar 2014
Study completion10 Mar 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: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01728857
Sponsor's protocol ID: ZA12-007
Acronym: TOPS
Status last verified: Mar 2025
First submitted: 13 Nov 2012
Last updated: 19 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of Tissue Optimization on Cryolipolysis Procedures for Fat Layer Reduction
ClinicalTrials.gov ID: NCT01728857
Acronym / sponsor ID: TOPS / ZA12-007
Conditions: Body Fat Disorder
Keywords: Lipolysis, Cryolipolysis, Fat Reduction
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: Zeltiq AestheticsIndustry (pharma, biotech, devices)
Study start: Nov 2012 (actual)
Primary completion: 10 Mar 2014 (actual)
Study completion: 10 Mar 2014 (actual)
First posted: 20 Nov 2012 (estimated)
Results: Posted 19 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Evaluate the effects of tissue optimization before and during cryolipolysis procedures on the outcome of non-invasive fat reduction using the ZELTIQ System.

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 System

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 intended treatment area, which in the investigator's opinion, may benefit from the treatment(s).
Subject has not had weight change exceeding 10 pounds in the preceding month.
Subject with body mass index (BMI) less than 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 (17 listed)

Subject presents a significant asymmetry of intended treatment areas.
Subject has had a surgical procedure(s) in the area of intended treatment in the past 5 years.
Subject has had an invasive fat reduction procedure (e.g., liposuction, abdominoplasty, mesotherapy) in the area of intended treatment in the past 5 years.
Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 6 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.

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	Fat Reduction

Primary outcome

Percentage of Before and After Side-by-side Photographs Correctly Identified by At Least 2 of 3 Blinded Reviewers From the Independent Physician Reviewer (IPR) Panel
Time frame: Baseline, Week 16
Photographs of the treatment areas were taken at baseline, and at 16-weeks after the first treatment with the ZELTIQ System were assessed for any visual changes. The photographs were assessed by blinded independent reviewers (IPR) to correctly identify the 16-weeks post-treatment photographs from randomly placed side-by-side comparison of before and after photographs. Reported here is the percentage (%) of images that were correctly identified by at least 2 out of 3 blinded independent reviewers.

1 secondary outcome

Change From Baseline in Reduction of Fat Layer Thickness as Assessed by Ultrasound
Time frame: Baseline, Week 16

Results and safety

Results posted to the registry on 19 Mar 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
The ZELTIQ System	19	19

Primary outcome: Percentage of Before and After Side-by-side Photographs Correctly Identified by At Least 2 of 3 Blinded Reviewers From the Independent Physician Reviewer (IPR) Panel

Time frame: Baseline, Week 16. Number (95% Confidence Interval). Unit: % of images identified correctly

Measure	The ZELTIQ System n = 13
Value	30.8 (9.1 to 61.4)

Population analysed: Per-protocol Population included all the treated participants followed for 16 weeks post-treatment with weight change of no more than five pounds at the Week 16 visit. Here, 'Overall Number of Participants Analyzed' is the number of participants evaluable for this Endpoint.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From date of first treatment up to Week 16. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
The ZELTIQ System	0 of 19 (0%)	5 of 19 (26.3%)	0 of 19

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 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.

Director Clinical Development - Body Contouring study director

Zeltiq Aesthetics

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 6 inclusion and 17 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 19 Mar 2025. 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 19 Mar 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?

Percentage of Before and After Side-by-side Photographs Correctly Identified by At Least 2 of 3 Blinded Reviewers From the Independent Physician Reviewer (IPR) Panel (time frame: Baseline, Week 16). 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 NCT01728857.

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 19 Mar 2025.