Non-Invasive Reduction of Abdominal Fat (JUNO)

This study has been completed.
Sponsor:
Information provided by:
Zeltiq Aesthetics
ClinicalTrials.gov Identifier:
NCT01101997
First received: April 5, 2010
Last updated: June 16, 2011
Last verified: April 2010
  Purpose

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


Condition Intervention
Fat Reduction
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 Abdominal Fat Utilizing the JUNO Applicator

Further study details as provided by Zeltiq Aesthetics:

Primary Outcome Measures:
  • The primary effectiveness endpoint is the correct identification of the series of pre-treatment images by three independent reviewers. It is expected that the percentage of correct identification of the pre-treatment images will be at least 80%. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    The pre and post treatment images will be reviewed by three qualified and independent reviewers. The reviewers will be asked to select the pre-treatment images. The success rate is defined at the correct selection of the pre-treatment images. The expected success rate is 80%.


Secondary Outcome Measures:
  • Reduction in the fat layer thickness of the treated area [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Reduction in the fat layer thickness, as demonstrated by comparison of pre-treatment and 16 week post-treatment ultrasound measurements

  • Subject Satisfaction [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Subject satisfaction with the Zeltiq procedure as determined by the results of a subjects satisfaction questionnaire at the 16 week follow up visit.


Estimated Enrollment: 50
Study Start Date: April 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: The Zeltiq System
    Noninvasive 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 achieve a discernable change to the contour of the abdominal area treated with the JUNO applicator that is consistent with that documented during a clinical study of a previous applicator used to treat lovehandles.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or female subjects > 18 years of age.
  2. Subject has clearly visible fat on the abdomen.
  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 in the past 6 months.
  2. Subject has had an invasive fat reduction procedure (e.g., liposuction, abdominoplasty, mesotherapy) in the area of intended treatment within the past year.
  3. Subject has had a non-invasive fat reduction procedure in the area of intended treatment within the past 6 months.
  4. Subject 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 Reynaud'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 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: NCT01101997

Locations
United States, California
Laser and Skin Surgery of Northern California
Sacramento, California, United States, 95816
United States, Florida
Flor Mayoral, M.D.
Coral Gables, Florida, United States, 33143
United States, Maryland
Maryland Laser, Skin and Vein Institute
Hunt Valley, Maryland, United States, 21030
United States, Massachusetts
Skin Care Physicians of Chestnut Hill
Chestnut Hill, Massachusetts, United States, 02467
United States, Minnesota
Zel Skin and Laser Specialist LLC
Edina, Minnesota, United States, 55424
Sponsors and Collaborators
Zeltiq Aesthetics
  More Information

No publications provided

Responsible Party: Tonia Madere, Zeltiq Aesthetics
ClinicalTrials.gov Identifier: NCT01101997     History of Changes
Other Study ID Numbers: ZA10-001
Study First Received: April 5, 2010
Last Updated: June 16, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Zeltiq Aesthetics:
Lipolysis
Cryolipolysis
Fat Reduction

ClinicalTrials.gov processed this record on October 22, 2014