Multiple CoolSculpting Treatment Study

NCT ID: NCT01814007

Last Updated: 2021-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2013-10-22

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,

Conditions

Body Fat Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

The Zeltiq CoolSculpting System

Intervention Type: DEVICE

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

Interventions

The Zeltiq CoolSculpting System

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

Intervention Type: DEVICE

Other Intervention Names

Cryolipolysis; Lipolysis

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zeltiq Aesthetics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric Bachelor, MD

Role: PRINCIPAL_INVESTIGATOR

Innovation Research Center

Locations

Innovation Research Center

Pleasanton, California, United States

Ed Becker, MD

Walnut Creek, California, United States

Bowes Dermatology Group

Miami, Florida, United States

Countries

United States

Related Links

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5573959/

Multiple same day cryolipolysis treatments for the reduction of subcutaneous fat are safe and do not affect serum lipid levels or liver function tests

Other Identifiers

ZA13-001

Identifier Type: -

Identifier Source: org_study_id