Outer Thigh Study With Varied Treatment Parameters

Non-Invasive Fat Layer Reduction in the Lateral Thighs With a Cryolipolysis System Using Varied Treatment Parameters

The purpose of this study is to compare the performance of a cryolipolysis system using various treatment parameters for non-invasive reduction of subcutaneous fat in the lateral thighs.

Study Overview

• Status: Completed
• Conditions: Body Fat Disorder
• Intervention / Treatment: Device: The Zeltiq System

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Marina del Rey, California, United States, 90292
      • Marina Plastic Surgery
    • Pleasanton, California, United States, 94588
      • Innovation Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• 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 intended treatment area (lateral thighs), which 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 their 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, 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 2 months.
4. Subject has significant asymmetry between the lateral thighs.
5. 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.
6. Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
7. 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.
8. 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.
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 (stretch marks is not an exclusion).
11. Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system
12. Subject is pregnant or intending to become pregnant during the study period (in the next 5 months).
13. Subject is lactating or has been lactating in the past 6 months.
14. Subject is unable or unwilling to comply with the study requirements.
15. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
16. 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: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate safety and efficacy of treatment	Safety endpoint is the rate of unanticipated adverse device effects (UADE) at 8-week and 16 week post treatment. It is expected there will be zero UADE. Efficacy will be evaluated by a photo review of pre-treatment vs. 16-week post-treatment images.	16-weeks post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction measured by ultrasound	Reduction in fat layer thickness, as measured by ultrasound, at 16 weeks post-treatment.	16-weeks post treatment
Subject satisfaction	Subject satisfaction as assessed by questionnaires.	16-weeks post treatment

Collaborators and Investigators

• Sponsor: Zeltiq Aesthetics
• Investigators: Principal Investigator: Eric Bachelor, MD, Innovation Research Center

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2014
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: March 4, 2014
• First Submitted That Met QC Criteria: March 4, 2014
• First Posted (Estimate): March 7, 2014

Study Record Updates

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

More Information

Terms related to this study

• Keywords: Lipolysis; Cryolipolysis; Fat Reduction
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders
• Other Study ID Numbers: ZA14-001

Plan for Individual participant data (IPD)

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