Body Fat DisorderNCT01814007

Multiple CoolSculpting Treatment Study

A study testing The Zeltiq CoolSculpting System in people with Body Fat Disorder, run by Zeltiq Aesthetics at 3 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

To evaluate the safety of same-day CoolSculpting treatments and to assess the impact on serum lipids and liver-related tests. 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: 35 participants
Where: 3 sitesUnited States
Study dates: Mar 2013to 22 Oct 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.
Subject who has been assessed to receive multiple CoolSculpting treatments on the abdomen and flanks, defined as follows:
Lower Abdomen - One 60 minute cycle with CoolMax,
Right and Left Flank - One 60 minute cycle per flank, with CoolCurve+ or CoolCore, simultaneously.
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 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 an invasive (e.g., liposuction, mesotherapy, abdominoplasty) or 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.
Subject has a history of hernia in the area(s) to be treated.
Subject is pregnant or intending to become pregnant during the study period (in the next 4 months).
Subject is lactating or has been lactating during the past 3 months.

Show all 12Show fewer

Subject is unable or unwilling to comply with the study requirements, such as blood draw.
Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
Subject has a history of lipodosis or other confounding metabolic diseases.
Subject is taking or has taken medication within the past 3 months which may affect the metabolic function.
Patient has a history of diabetes.
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

3 sites in 1 country.

United States3 sites

Bowes Dermatology Group
Miami, Florida, 33133
Innovation Research Center
Pleasanton, California, 94588
Ed Becker, MD
Walnut Creek, California, 94598

Other trials in United States

About this study

Official title: Safety Evaluation of Multiple CoolSculpting Treatments

To evaluate the safety of same-day CoolSculpting treatments and to assess the impact on serum lipids and liver-related tests.

Read the detailed description

The study will evaluate the safety of multiple same-day CoolSculpting treatments and will assess any impact on serum lips or liver-related analytes,

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, Lipolysis
Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.

Study groups in NCT01814007
Study group	Role	What they receive
CoolSculpting Treatment Group	Experimental	CoolSculpting treatments will be performed on all subjects with 1 cooling cycle on the lower abdomen, plus simultaneous treatment of both flanks, one cooling cycle each. Two control units will be utilized at protocol-defined temperatures and durations. Receives: Device: The Zeltiq CoolSculpting System

What is being measured

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

Evaluation of Liver- Related Tests Over Time
Blood draws will be collected pre-treatment, 1-week, 4-weeks, 12-weeks post treatment. Changes in each analyte was evaluated for consistency with normal variation and for change relative to the reference range of the component (high/low), pre-treatment versus post-treatment by an independent physician. The independent physician reviewer was provided with laboratory results and other pertinent information for each subject, including demographic, medical history, and concomitant medications. For every change in laboratory value over time, the reviewer was required to make a determination of whether the change in value represented a clinically meaningful change. In addition, for any change in a laboratory value that exceeded 25% change, or any value outside of normal range, the reviewer was required to provide a written rationale for the determination of clinical meaningfulness.
Measured: Pre-treatment; 1 week, 4 weeks, and 12 weeks post-treatment
Evaluation of Liver-Related Tests Over Time
Blood draws will be collected pre-treatment, 1-week, 4-weeks, 12-weeks post treatment. Changes in each analyte was evaluated for consistency with normal variation and for change relative to the reference range of the component (high/low), pre-treatment versus post-treatment by an independent physician. The independent physician reviewer was provided with laboratory results and other pertinent information for each subject, including demographic, medical history, and concomitant medications. For every change in laboratory values over time, the reviewer was required to make a determination of whether the change in value represented a clinically meaningful change. In addition, for any change in a laboratory value that exceeded 25% change, or any value outside of normal range, the reviewer was required to provide a written rationale for the determination of clinical meaningfulness.
Measured: Pretreatment, 1 week, 4 weeks 12 weeks post-treatment
Evaluation of Serum Lipid Values Over Time
Blood draws will be collected pre-treatment, 1-week, 4-weeks, 12-weeks post treatment. Changes in each analyte was evaluated for consistency with normal variation and for change relative to the reference range of the component (high/low), pre-treatment versus post-treatment by an independent physician. The independent physician reviewer was provided with laboratory results and other pertinent information for each subject, including demographic, medical history, and concomitant medications. For every change in laboratory values over time, the reviewer was required to make a determination of whether the change in value represented a clinically meaningful change. In addition, for any change in a laboratory value that exceeded 25% change, or any value outside of normal range, the reviewer was required to provide a written rationale for the determination of clinical meaningfulness.
Measured: Pre-treatment, 1 week, 4 weeks, 12 weeks post-treatment
Safety of the Device and/or Procedure as Assessed by the Incidence of SAE and UADE
The primary safety end point is the incidence of Serious Adverse Events (SAE) and Unanticipated Adverse Device Effects (UADE).
Measured: 12 weeks post treatment

Secondary outcomes (3)

Safety as Evaluated by the Number and Severity of All Reported Adverse Events.
All adverse will be assessed for frequency and severity from the time of enrollment though the 12 week follow-up visit.
Measured: 12 weeks post-treatment
Pain: Assessment of Pain Scores Reported on the Day of Treatment and at 12 Weeks Post-treatment.
Pain scores are collected using a 0 (no pain) to 10 (worst possible pain) scale. Scores will be collected immediately post-treatment and at the 12 week follow-up visit.
Measured: Treatment day and 12 week post-treatment follow-up
Side Effects in Treatment Area
Clinical assessments of the skin at the treatment sites to be performed immediately post-treatment, and at the 12 week follow-up visit. Subjects will be evaluated for skin changes at the treatment sites. The scale used by clinicians for the assessments is 0 = absent, 1= minor, 2= moderate, 3= severe.
Measured: Treatment day and 12 week post-treatment follow-up

Timeline

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

Mar 201322 Oct 2013

First posted19 Mar 2013 (estimated)
Study startMar 2013
Primary completion22 Jul 2013
Study completion22 Oct 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: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01814007
Sponsor's protocol ID: ZA13-001
Status last verified: Nov 2020
First submitted: 4 Mar 2013
Last updated: 17 May 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: 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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety Evaluation of Multiple CoolSculpting Treatments
ClinicalTrials.gov ID: NCT01814007
Acronym / sponsor ID: ZA13-001
Conditions: Body Fat Disorder
Keywords: Lipolysis, Cryolipolysis, Fat Reduction
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: Zeltiq AestheticsIndustry (pharma, biotech, devices)
Study start: Mar 2013
Primary completion: 22 Jul 2013 (actual)
Study completion: 22 Oct 2013 (actual)
First posted: 19 Mar 2013 (estimated)
Results: Posted 2 Dec 2020

Clinical summary

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

To evaluate the safety of same-day CoolSculpting treatments and to assess the impact on serum lipids and liver-related tests.

Detailed description

The study will evaluate the safety of multiple same-day CoolSculpting treatments and will assess any impact on serum lips or liver-related analytes,

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
CoolSculpting Treatment Group	Experimental	Device: The Zeltiq CoolSculpting SystemCoolSculpting treatments will be performed on all subjects with 1 cooling cycle on the lower abdomen, plus simultaneous treatment of both flanks, one cooling cycle each. Two control units will be utilized 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 (8 listed)

Male or female subjects > 18 years of age.
Subject who has been assessed to receive multiple CoolSculpting treatments on the abdomen and flanks, defined as follows:
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 not making any major changes in their diet or lifestyle during the course of the study.

Key exclusion criteria (12 listed)

Subject has had an invasive (e.g., liposuction, mesotherapy, abdominoplasty) or 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.
Subject has a history of hernia in the area(s) to be treated.
Subject is pregnant or intending to become pregnant during the study period (in the next 4 months).

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: Cryolipolysis, LipolysisNon-invasive cooling is applied to the treatment area with a defined cooling rate and duration.	Device	CoolSculpting Treatment Group

Primary outcome

Evaluation of Liver- Related Tests Over Time
Time frame: Pre-treatment; 1 week, 4 weeks, and 12 weeks post-treatment
Blood draws will be collected pre-treatment, 1-week, 4-weeks, 12-weeks post treatment. Changes in each analyte was evaluated for consistency with normal variation and for change relative to the reference range of the component (high/low), pre-treatment versus post-treatment by an independent physician. The independent physician reviewer was provided with laboratory results and other pertinent information for each subject, including demographic, medical history, and concomitant medications. For every change in laboratory value over time, the reviewer was required to make a determination of whether the change in value represented a clinically meaningful change. In addition, for any change in a laboratory value that exceeded 25% change, or any value outside of normal range, the reviewer was required to provide a written rationale for the determination of clinical meaningfulness.
Evaluation of Liver-Related Tests Over Time
Time frame: Pretreatment, 1 week, 4 weeks 12 weeks post-treatment
Blood draws will be collected pre-treatment, 1-week, 4-weeks, 12-weeks post treatment. Changes in each analyte was evaluated for consistency with normal variation and for change relative to the reference range of the component (high/low), pre-treatment versus post-treatment by an independent physician. The independent physician reviewer was provided with laboratory results and other pertinent information for each subject, including demographic, medical history, and concomitant medications. For every change in laboratory values over time, the reviewer was required to make a determination of whether the change in value represented a clinically meaningful change. In addition, for any change in a laboratory value that exceeded 25% change, or any value outside of normal range, the reviewer was required to provide a written rationale for the determination of clinical meaningfulness.
Evaluation of Serum Lipid Values Over Time
Time frame: Pre-treatment, 1 week, 4 weeks, 12 weeks post-treatment
Blood draws will be collected pre-treatment, 1-week, 4-weeks, 12-weeks post treatment. Changes in each analyte was evaluated for consistency with normal variation and for change relative to the reference range of the component (high/low), pre-treatment versus post-treatment by an independent physician. The independent physician reviewer was provided with laboratory results and other pertinent information for each subject, including demographic, medical history, and concomitant medications. For every change in laboratory values over time, the reviewer was required to make a determination of whether the change in value represented a clinically meaningful change. In addition, for any change in a laboratory value that exceeded 25% change, or any value outside of normal range, the reviewer was required to provide a written rationale for the determination of clinical meaningfulness.
Safety of the Device and/or Procedure as Assessed by the Incidence of SAE and UADE
Time frame: 12 weeks post treatment
The primary safety end point is the incidence of Serious Adverse Events (SAE) and Unanticipated Adverse Device Effects (UADE).

3 secondary outcomes

Safety as Evaluated by the Number and Severity of All Reported Adverse Events.
Time frame: 12 weeks post-treatment
Pain: Assessment of Pain Scores Reported on the Day of Treatment and at 12 Weeks Post-treatment.
Time frame: Treatment day and 12 week post-treatment follow-up
Side Effects in Treatment Area
Time frame: Treatment day and 12 week post-treatment follow-up

Results and safety

Results posted to the registry on 2 Dec 2020, 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	35	34

Primary outcome: Evaluation of Liver- Related Tests Over Time

Time frame: Pre-treatment; 1 week, 4 weeks, and 12 weeks post-treatment. Least squares mean (Standard Deviation). Unit: units per liter (U/L)

Measure	CoolSculpting Treatment Group n = 35
Baseline Alk Phosphatase	62.12 (15.72)
1 week post treatment Alk Phosphatase	63.88 (14.71)
4 weeks post treatment Alk Phosphatase	63.74 (15.61)
12 week post treatment Alk Phosphatase	62.06 (15.4)
Baseline AST-SGOT	19.66 (5.16)
1 week post treatment AST-SGOT	19.76 (6.93)
4 weeks post treatment AST-SGOT	22.15 (8.77)
12 week post treatment AST-SGOT	23.03 (16.33)

Population analysed: Blood draws completed on 35 subjects at baseline. Two liver-related test results unavailable for 1 subject at baseline. Blood draws at the 1 week, 4 week and 12 week time periods reflect 34 subjects as one of the 35 subjects enrolled withdrew from the study. Liver-related test values were analyzed for each time point.

Primary outcome: Evaluation of Liver-Related Tests Over Time

Time frame: Pretreatment, 1 week, 4 weeks 12 weeks post-treatment. Least squares mean (Standard Deviation). Unit: mg/dl

Measure	Treatment Group n = 35
Total Bilirubin Baseline	0.65 (0.36)
Total Bilirubin 1 week	0.53 (0.24)
Total Bilirubin 4 weeks	0.61 (0.27)
Total Bilirubin 12 weeks	0.58 (0.28)

Population analysed: Total bilirubin test results were not available for 2 subjects for the baseline visit. Of the 35 subjects enrolled in the study, 1 subject withdrew from the study and had no further blood draws.

Primary outcome: Evaluation of Serum Lipid Values Over Time

Time frame: Pre-treatment, 1 week, 4 weeks, 12 weeks post-treatment. Least squares mean (Standard Deviation). Unit: mg/dl

Measure	Treatment Group n = 35
Cholesterol Baseline	186.54 (39.08)
Cholesterol 1 week	185.62 (36.9)
Cholesterol 4 weeks	188.38 (37.6)
Cholesterol 12 weeks	189.18 (39.76)
Triglycerides Baseline	76.97 (32.49)
Triglycerides 1 week	80.53 (33.19)
Triglycerides 4 weeks	77.68 (33.22)
Triglycerides 12 weeks	83.35 (38.59)

Population analysed: Of the 35 subjects enrolled, 1 subject withdrew and did not have blood draws performed after the baseline visit.

Primary outcome: Safety of the Device and/or Procedure as Assessed by the Incidence of SAE and UADE

Time frame: 12 weeks post treatment. Number. Unit: participants

Measure	CoolSculpting Treatment Group n = 35
Serious AE reported	1
UADEs reported	0

Population analysed: All treated subjects were included in the safety analysis population.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected from the time of enrollment through the 12-week follow-up visit.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CoolSculpting Treatment Group	1 of 35 (2.9%)	2 of 35 (5.7%)	0 of 35

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Multiple same day cryolipolysis treatments for the reduction of subcutaneous fat are safe and do not affect serum lipid levels or liver function testsLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Body 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.

Eric Bachelor, MD principal investigator

Innovation Research Center

3 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 3 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 8 inclusion and 12 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 17 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 2 Dec 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?

Evaluation of Liver- Related Tests Over Time (time frame: Pre-treatment; 1 week, 4 weeks, and 12 weeks post-treatment). The study lists 4 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 NCT01814007.

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 17 May 2021.