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Non-Invasive Reduction of Fat in the Inner Thighs

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01517659
First Posted: January 25, 2012
Last Update Posted: June 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Zeltiq Aesthetics
  Purpose
Evaluate the safety and efficacy of non-invasive fat reduction in the inner thighs with the ZELTIQ CoolSculpting System.

Condition Intervention
Body Fat Disorder Device: The Zeltiq System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Non-Invasive Reduction of Fat in the Inner Thighs With the Zeltiq Coolsculpting System

Further study details as provided by Zeltiq Aesthetics:

Primary Outcome Measures:
  • Efficacy and Safety [ Time Frame: 16 weeks post treatment ]
    • Efficacy endpoint: correct identification of pre-treatment vs. 16-week post-treatment images by three masked independent reviewers. Success will be defined as at least 80% correct identification of the pre-treatment images.
    • Safety endpoint: measurement of device- or procedure-related adverse events.


Secondary Outcome Measures:
  • Subject Satisfaction [ Time Frame: 16 weeks post final treatment ]
    Subject satisfaction as assessed by questionnaires administered at 16 weeks post-treatment.


Enrollment: 45
Study Start Date: November 2012
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Fat Reduction Device: The Zeltiq System
Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
Other Names:
  • Cryolipolysis
  • Lipolysis

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  1. Male or female subjects > 18 years of age and < 65 years of age.
  2. Subject has clearly visible fat on the inner thighs and in the investigator's opinion, may benefit from the treatment.
  3. Subject has not had weight change exceeding 10 pounds in the preceding month.
  4. 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.]
  5. Subject agrees to maintain his/her weight (i.e., within 5 pounds) by not making any major changes in his/her diet or lifestyle during the course of the study.
  6. Subject has read and signed a written informed consent form.

Exclusion Criteria

  1. Subject has had a surgical procedure(s) in the area of intended treatment.
  2. Subject has had an invasive fat reduction procedure (e.g., liposuction, abdominoplasty, mesotherapy) in the area of intended treatment.
  3. Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 6 months.
  4. Subject needs to administer, or has a known history of, subcutaneous injections (e.g., heparin, insulin) into the area of intended treatment within the past month.
  5. Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
  6. Subject has a known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
  7. Subject has a history of a bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
  8. Subject is taking or has taken diet pills or supplements within the past month.
  9. Subject has any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites that may interfere with the treatment or evaluation (stretch marks is not an exclusion).
  10. Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system
  11. Subject is pregnant or intends to become pregnant in the next 8 months.
  12. Subject is lactating or has been lactating in the past 6 months.
  13. Subject is unable or unwilling to comply with the study requirements.
  14. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
  15. 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01517659


Locations
United States, California
Laser & Skin Surgery Center of Northern California
Sacramento, California, United States, 95816
United States, Minnesota
Zel Skin and Laser Specialists
Edina, Minnesota, United States, 55424
United States, Texas
Dallas Plastic Surgery Institute
Dallas, Texas, United States, 75231
Sponsors and Collaborators
Zeltiq Aesthetics
Investigators
Principal Investigator: Suzanne Kilmer, MD Laser and Skin Surgery Center of Northern California
  More Information

Responsible Party: Zeltiq Aesthetics
ClinicalTrials.gov Identifier: NCT01517659     History of Changes
Other Study ID Numbers: ZA12-002
First Submitted: January 17, 2012
First Posted: January 25, 2012
Last Update Posted: June 22, 2017
Last Verified: November 2012
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Zeltiq Aesthetics:
Lipolysis
Cryolipolysis
Fat Reduction

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases


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