Clinical trial NCT01814007: Multiple CoolSculpting Treatment Study
Official title: Safety Evaluation of Multiple CoolSculpting Treatments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Fat Disorder
Keywords: Lipolysis
Cryolipolysis
Fat Reduction
Lead sponsor: Zeltiq Aesthetics
Sponsor class: INDUSTRY
First posted: 2013-03-19
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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,

Eligibility criteria: 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:

  1. Lower Abdomen - One 60 minute cycle with CoolMax,
  2. 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.

Primary outcomes:
measure: Evaluation of Liver- Related Tests Over Time
timeFrame: Pre-treatment; 1 week, 4 weeks, and 12 weeks post-treatment
measure: Evaluation of Liver-Related Tests Over Time
timeFrame: Pretreatment, 1 week, 4 weeks 12 weeks post-treatment
measure: Evaluation of Serum Lipid Values Over Time
timeFrame: Pre-treatment, 1 week, 4 weeks, 12 weeks post-treatment
measure: Safety of the Device and/or Procedure as Assessed by the Incidence of SAE and UADE
timeFrame: 12 weeks post treatment
Secondary outcomes:
measure: Safety as Evaluated by the Number and Severity of All Reported Adverse Events.
timeFrame: 12 weeks post-treatment
measure: Pain: Assessment of Pain Scores Reported on the Day of Treatment and at 12 Weeks Post-treatment.
timeFrame: Treatment day and 12 week post-treatment follow-up
measure: Side Effects in Treatment Area
timeFrame: Treatment day and 12 week post-treatment follow-up
Other outcomes:
Locations:
city: Pleasanton
country: United States
facility: Innovation Research Center
state: California
city: Walnut Creek
country: United States
facility: Ed Becker, MD
state: California
city: Miami
country: United States
facility: Bowes Dermatology Group
state: Florida
Study officials:
affiliation: Innovation Research Center
name: Eric Bachelor, MD
role: PRINCIPAL_INVESTIGATOR
References: