- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01814007
Multiple CoolSculpting Treatment Study
May 13, 2021 updated by: Zeltiq Aesthetics
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
35
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Pleasanton, California, United States, 94588
- Innovation Research Center
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Walnut Creek, California, United States, 94598
- Ed Becker, MD
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Florida
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Miami, Florida, United States, 33133
- Bowes Dermatology Group
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CoolSculpting Treatment Group
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.
|
Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Pre-treatment; 1 week, 4 weeks, and 12 weeks post-treatment
|
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.
|
Pretreatment, 1 week, 4 weeks 12 weeks post-treatment
|
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.
|
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
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).
|
12 weeks post treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety as Evaluated by the Number and Severity of All Reported Adverse Events.
Time Frame: 12 weeks post-treatment
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All adverse will be assessed for frequency and severity from the time of enrollment though the 12 week follow-up visit.
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12 weeks post-treatment
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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
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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.
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Treatment day and 12 week post-treatment follow-up
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Side Effects in Treatment Area
Time Frame: Treatment day and 12 week post-treatment follow-up
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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.
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Treatment day and 12 week post-treatment follow-up
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Eric Bachelor, MD, Innovation Research Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2013
Primary Completion (Actual)
July 22, 2013
Study Completion (Actual)
October 22, 2013
Study Registration Dates
First Submitted
March 4, 2013
First Submitted That Met QC Criteria
March 14, 2013
First Posted (Estimate)
March 19, 2013
Study Record Updates
Last Update Posted (Actual)
May 17, 2021
Last Update Submitted That Met QC Criteria
May 13, 2021
Last Verified
November 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZA13-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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