Multiple CoolSculpting Treatment Study

NCT01814007 | Completed Results FDA Device

• 1 other identifier: ZA13-001
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Body Fat Disorder

Keywords

Lipolysis; Cryolipolysis; Fat Reduction

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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).

  12 weeks post treatment

Secondary Outcomes (3)

• Safety as Evaluated by the Number and Severity of All Reported Adverse Events.

  12 weeks post-treatment

• Pain: Assessment of Pain Scores Reported on the Day of Treatment and at 12 Weeks Post-treatment.

  Treatment day and 12 week post-treatment follow-up

• Side Effects in Treatment Area

  Treatment day and 12 week post-treatment follow-up

Study Arms (1)

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.

Device: The Zeltiq CoolSculpting System

Interventions

The Zeltiq CoolSculpting System DEVICE

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

Also known as: Cryolipolysis, Lipolysis

CoolSculpting Treatment Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zeltiq Aesthetics: lead

Study Sites (3)

Innovation Research Center

Pleasanton, California, 94588, United States

Location

Ed Becker, MD

Walnut Creek, California, 94598, United States

Location

Bowes Dermatology Group

Miami, Florida, 33133, United States

Location

Related Links

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

MeSH Terms

Interventions

Lipectomy

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Bariatric Surgery; Bariatrics; Obesity Management; Surgical Procedures, Operative; Plastic Surgery Procedures

Results Point of Contact

• Title: Kerrie Jiang, Executive Director Regulatory, Clinical and Medical Affairs
• Organization: Zeltiq Aesthetics

kerrie.jiang@allergan.com

(925) 621-7462

Study Officials

• Eric Bachelor, MD

  Innovation Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2013
• First Posted: March 19, 2013
• Study Start: March 1, 2013
• Primary Completion: July 22, 2013
• Study Completion: October 22, 2013
• Last Updated: May 17, 2021
• Results First Posted: December 2, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)