Multiple CoolSculpting Treatment Study

Zeltiq Aesthetics

Status: Completed

Conditions: Body Fat Disorder

Treatments: Device: The Zeltiq CoolSculpting System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01814007

ZA13-001

Details and patient eligibility

About

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

Full 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,

Enrollment: 35 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

CoolSculpting Treatment Group

Experimental group

Description:

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.

Treatment:

Device: The Zeltiq CoolSculpting System