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

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

Study Overview

• Status: Completed
• Conditions: Fat Reduction in the Upper Arm
• Intervention / Treatment: Device: The Zeltiq System

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6J IZ6
      • Arbutus Laser Centre
  • Ontario
    • Oakville, Ontario, Canada, L6J 7W5
      • Institute of Cosmetic and Laser Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Independent imaging review	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.	16 weeks

Collaborators and Investigators

• Sponsor: Zeltiq Aesthetics
• Investigators: Principal Investigator: Gerald Boey, MD, Arbutus Laser Centre

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: July 8, 2011
• First Submitted That Met QC Criteria: July 8, 2011
• First Posted (Estimate): July 12, 2011

Study Record Updates

• Last Update Posted (Actual): June 22, 2017
• Last Update Submitted That Met QC Criteria: June 20, 2017
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: Lipolysis; Cryolipolysis; Fat Reduction
• Other Study ID Numbers: ZA11-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO