DualSculpting the Abdomen Using CoolSculpting

Body Fat Disorder Clinical Trial

— DSA  

Official title:

DualSculpting the Abdomen Using CoolSculpting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02941146
• Other study ID #: ZA16-004
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: March 29, 2017

Study information

• Verified date: October 2016
• Source: Zeltiq Aesthetics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluate the safety and efficacy of abdominal DualSculpting with CoolAdvantage applicators.

Description:

The study will evaluate the safety and efficacy of non-invasive fat reduction in the abdomen using two applicators.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 29, 2017
• Est. primary completion date: March 29, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 65 Years

Eligibility

Inclusion Criteria

1. Male or female subjects >22 years of age and < 65 years of age.

2. Subject who has been assessed to be eligible to receive multiple DualSculpting treatments on the abdomen using the CoolAdvantage and/or CoolAdvantage Plus applicator.

3. No weight change exceeding 5% of body weight in the preceding month.

4. Subject agrees to maintain his/her weight (i.e., within 5%) by not making any major changes in their diet or exercise routine during the course of the study.

5. Subject has read and signed the study written informed consent form.

Exclusion Criteria

1. Subject has had a surgical procedure(s) in the area of intended treatmentSubject 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 12 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, cold agglutinin disease 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 is taking or has taken diet pills or supplements within the past month.

9. 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).

10. Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system or any other metal containing implant.

11. Subject is pregnant or intending to become pregnant during the study period

12. Subject is lactating or has been lactating in the past 6 months.

13. Subject has a history of hernia in the areas to be treated.

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.

Related Conditions & MeSH terms

• Body Fat Disorder
• Lipid Metabolism Disorders

Intervention

Device:
• The ZELTIQ System
The CoolSculpting System will be used to perform the treatments with the CoolAdvantage family of applicators.

Locations

Country	Name	City	State
United States	Main Line Center for Laser Surgery	Ardmore	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Zeltiq Aesthetics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Correctly Identified Photos by Blinded Reviewers	Change in the treated vs. untreated areas will be assessed by observation of changes in surface contour and/or fat volume by an independent photo review of pre-treatment and post-treatment images. Reviewers will be practicing dermatologists or plastic surgeons. All reviewers will be blinded to post-treatment vs. baseline untreated area. The order in which images will be presented will be randomized; for each subject placement of the baseline, pre-treatment image will be randomized for each pair of subject images. Reviewers will be asked to select the baseline photos for each subject photo series and record selections on a data collection form. The primary efficacy endpoint of the study was the correct identification of baseline (pre-treatment) vs. 12 weeks post-final treatment images by two out of three blinded, independent reviewers. Success was defined as at least 70% correct identification of the baseline (pre-treatment) photographs.	Baseline to 12 weeks post-treatment
Primary	Safety of the Zeltiq Device	The incidence of unanticipated adverse device effects will be measured. It is expected there will be zero UADEs.	12 week post-treatment
Secondary	Subject Satisfaction	Subject satisfaction with the Zeltiq procedure as determined by positive responses in a subject satisfaction questionnaire administered at the 12 weeks post-treatment visit. This questionnaire will be composed of 5-point Likert scale questions, as well as free-text responses, with lower numbers (e.g. 1 or 2) indicating positive responses and higher numbers indicating less positive responses.	12 weeks post-treatment