Tissue Optimization on Cryolipolysis Procedures for Fat Layer Reduction

Body Fat Disorder Clinical Trial

— TOPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01728857
• Other study ID #: ZA12-007
• Status: Completed
• Phase: N/A
• First received: November 13, 2012
• Last updated: June 20, 2017
• Start date: November 2012
• Est. completion date: June 2017

Study information

• Verified date: June 2017
• Source: Zeltiq Aesthetics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Fat Disorder
• Lipid Metabolism Disorders

Intervention

Device:
• The Zeltiq System
Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.

Locations

Country	Name	City	State
United States	Innovation Research Center	Pleasanton	California

Sponsors (1)

Lead Sponsor	Collaborator
Zeltiq Aesthetics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy	Effectiveness: Comparison of pre- and 16-week post-treatment photographs of the treatment areas to select the side with greater improvement.	16 weeks post final treatment
Secondary	Photographs pre and 8-week post	Comparison of pre- and 8-week post-treatment photographs of the treatment areas to select the side with greater improvement.	8 weeks post final treatment