Non-Invasive Reduction of Abdominal Fat

Not Applicable

Completed

• Conditions: Fat Reduction
• Interventions: Device: The Zeltiq System

• Registration Number: NCT01101997
• Lead Sponsor: Zeltiq Aesthetics

Brief Summary

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

Detailed Description

The primary objective of the study is to achieve a discernable change to the contour of the abdominal area treated with the JUNO applicator that is consistent with that documented during a clinical study of a previous applicator used to treat lovehandles.

Study Timeline

• Study Start: 2010-03-30
• Study First Submitted: 2010-04-05
• Study First Submitted QC: 2010-04-09
• Study First Posted: 2010-04-12
• Primary Completion: 2010-09-28
• Study Completion: 2010-12-08
• Status Verified: 2020-08
• Results First Submitted: 2020-08-27
• Results First Submitted QC: 2020-11-24
• Last Update Submitted: 2020-11-24
• Results First Posted: 2020-12-21
• Last Update Posted: 2020-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Male or female subjects > 18 years of age.
2. Subject has clearly visible fat on the abdomen.
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 in the past 6 months.
2. Subject has had an invasive fat reduction procedure (e.g., liposuction, abdominoplasty, mesotherapy) in the area of intended treatment within the past year.
3. Subject has had a non-invasive fat reduction procedure in the area of intended treatment within the past 6 months.
4. Subject 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 Reynaud'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 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental: Abdomen Treatment Group	The Zeltiq System	All subjects were treated on the abdomen with the CoolSculpting system.

Primary Outcome Measures

Name	Time	Method
Proportion of Pre-treatment Images Correctly Identified	16 weeks	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 of the treated areas. 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 expected success rate is an average 80% correct identification by the three reviewers.

Secondary Outcome Measures

Name	Time	Method
Subject Satisfaction	16 weeks	Subject satisfaction with the Zeltiq procedure as determined by the results of a subjects satisfaction questionnaire at the 16 week follow up visit.
Change in the Fat Layer of the Treated Area as Measured by Ultrasound	16 weeks	Change in the fat layer thickness will be calculated by comparison of pre-treatment and 16 week post-treatment ultrasound measurements taken in the area treated with the device, and in the adjacent untreated control area. The Sponsor's standardized techniques for obtaining ultrasound imaging will be used. Overall fat layer thickness changes were normalized for each subject by subtracting the change in control from the change in treated area to remove the influence of weight variations. Results indicate the fat layer reduction in mm.

Trial Locations

Locations (5)

Skin Care Physicians of Chestnut Hill; 🇺🇸 Chestnut Hill, Massachusetts, United States

Flor Mayoral, M.D.; 🇺🇸 Coral Gables, Florida, United States

Laser and Skin Surgery of Northern California; 🇺🇸 Sacramento, California, United States

Maryland Laser, Skin and Vein Institute; 🇺🇸 Hunt Valley, Maryland, United States

Zel Skin and Laser Specialist LLC; 🇺🇸 Edina, Minnesota, United States