Non-Invasive Reduction of Fat in the Arms With the CoolFlex Applicator

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zeltiq Aesthetics
ClinicalTrials.gov Identifier:
NCT01391923
First received: July 8, 2011
Last updated: March 15, 2012
Last verified: March 2012
  Purpose

This study is being performed to reduce unwanted fat in the arm using a new applicator for the Zeltiq System.


Condition Intervention
Fat Reduction in the Upper Arm
Device: The Zeltiq System

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Non-Invasive Reduction of Fat in the Arms With the CoolFlex Applicator

Further study details as provided by Zeltiq Aesthetics:

Primary Outcome Measures:
  • Independent imaging review [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Performance will be evaluated by changes in the contour as established by blinded photographic review of a series of pre- and 16-week post-treatment images for each subject.


Enrollment: 20
Study Start Date: July 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: The Zeltiq System
    Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
    Other Names:
    • Cryolipolysis
    • Lipolysis
Detailed Description:

The primary objective of the study is to evaluate the safety and performance of the CoolFlex applicator in the flat configuration for reduction of fat in the upper arms.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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 underside of the upper arm, generally located over the triceps muscle. (Figure 1)
  3. Subject has not had weight change exceeding 10 pounds in the preceding month.
  4. Subject agrees to maintain their weight (i.e., within 5 pounds) by not making any major changes in their diet or lifestyle during the course of the study.
  5. 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 or 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 into the area of intended treatment (e.g., heparin, insulin) 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 bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
  8. Subject body mass index (BMI) exceeds 40. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.
  9. Subject is taking or has taken diet pills or supplements within the past month.
  10. 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.
  11. Subject is pregnant or intending to become pregnant in the next 6 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01391923

Locations
Canada, British Columbia
Arbutus Laser Centre
Vancouver, British Columbia, Canada, V6J IZ6
Canada, Ontario
Institute of Cosmetic and Laser Surgery
Oakville, Ontario, Canada, L6J 7W5
Sponsors and Collaborators
Zeltiq Aesthetics
  More Information

No publications provided

Responsible Party: Zeltiq Aesthetics
ClinicalTrials.gov Identifier: NCT01391923     History of Changes
Other Study ID Numbers: ZA11-002
Study First Received: July 8, 2011
Last Updated: March 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Zeltiq Aesthetics:
Lipolysis
Cryolipolysis
Fat Reduction

ClinicalTrials.gov processed this record on August 20, 2014