Tissue Optimization on Cryolipolysis Procedures for Fat Layer Reduction (TOPS)

The Effects of Tissue Optimization on Cryolipolysis Procedures for Fat Layer Reduction

Evaluate the effects of tissue optimization before and during cryolipolysis procedures on the outcome of non-invasive fat reduction using the ZELTIQ System.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • 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: Yes

Description

Inclusion Criteria

1. Male or female subjects > 18 years of age and < 65 years of age.
2. Subject has clearly visible fat on intended treatment area, which in the investigator's opinion, may benefit from the treatment(s).
3. Subject has not had weight change exceeding 10 pounds in the preceding month.
4. Subject with body mass index (BMI) less than 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 presents a significant asymmetry of intended treatment areas.
2. Subject has had a surgical procedure(s) in the area of intended treatment in the past 5 years.
3. Subject has had an invasive fat reduction procedure (e.g., liposuction, abdominoplasty, mesotherapy) in the area of intended treatment in the past 5 years.
4. Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 6 months.
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 weight control 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 in the next 5 months.
13. Subject is lactating or has been lactating in the past 6 months.
14. Subject has a history of hernia in the areas to be treated.
15. Subject is unable or unwilling to comply with the study requirements.
16. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
17. 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
Percentage of Before and After Side-by-side Photographs Correctly Identified by At Least 2 of 3 Blinded Reviewers From the Independent Physician Reviewer (IPR) Panel	Photographs of the treatment areas were taken at baseline, and at 16-weeks after the first treatment with the ZELTIQ System were assessed for any visual changes. The photographs were assessed by blinded independent reviewers (IPR) to correctly identify the 16-weeks post-treatment photographs from randomly placed side-by-side comparison of before and after photographs. Reported here is the percentage (%) of images that were correctly identified by at least 2 out of 3 blinded independent reviewers.	Baseline, Week 16

Secondary Outcome Measures

Outcome Measure	Time Frame
Change From Baseline in Reduction of Fat Layer Thickness as Assessed by Ultrasound	Baseline, Week 16

Collaborators and Investigators

• Sponsor: Zeltiq Aesthetics
• Investigators: Study Director: Director Clinical Development - Body Contouring, Zeltiq Aesthetics

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2012
• Primary Completion (Actual): March 10, 2014
• Study Completion (Actual): March 10, 2014

Study Registration Dates

• First Submitted: November 13, 2012
• First Submitted That Met QC Criteria: November 19, 2012
• First Posted (Estimated): November 20, 2012

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 13, 2025
• Last Verified: March 1, 2025

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: ZA12-007

Plan for Individual participant data (IPD)

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