Non-Invasive Reduction of Abdominal Fat

NCT01101997 | Completed Results FDA Device

• 1 other identifier: ZA10-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Fat Reduction

Keywords

Lipolysis; Cryolipolysis; Fat Reduction

Outcome Measures

Primary Outcomes (1)

• Proportion of Pre-treatment Images Correctly Identified

  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.

  16 weeks

Secondary Outcomes (2)

• Change in the Fat Layer of the Treated Area as Measured by Ultrasound

  16 weeks

• Subject Satisfaction

  16 weeks

Study Arms (1)

Experimental: Abdomen Treatment Group

EXPERIMENTAL

All subjects were treated on the abdomen with the CoolSculpting system.

Device: The Zeltiq System

Interventions

The Zeltiq System DEVICE

Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration.

Also known as: Cryolipolysis, Lipolysis

Experimental: Abdomen Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects \> 18 years of age.
• Subject has clearly visible fat on the abdomen.
• Subject has not had weight change exceeding 10 pounds in the preceding month.
• 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.
• Subject has read and signed a written informed consent form.

You may not qualify if:

• Subject has had a surgical procedure(s) in the area of intended treatment in the past 6 months.
• Subject has had an invasive fat reduction procedure (e.g., liposuction, abdominoplasty, mesotherapy) in the area of intended treatment within the past year.
• Subject has had a non-invasive fat reduction procedure in the area of intended treatment within the past 6 months.
• Subject has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.
• Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
• 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.
• 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.
• 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.
• Subject is taking or has taken diet pills or supplements within the past month.
• Subject has any dermatological conditions or scars in the location of the treatment sites that may interfere with the treatment or evaluation.
• Subject is pregnant or intending to become pregnant in the next 6 months.
• Subject is lactating or has been lactating in the past 6 months.
• Subject is unable or unwilling to comply with the study requirements.
• Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
• 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.

Sponsors & Collaborators

• Zeltiq Aesthetics: lead

Study Sites (5)

Laser and Skin Surgery of Northern California

Sacramento, California, 95816, United States

Location

Flor Mayoral, M.D.

Coral Gables, Florida, 33143, United States

Location

Maryland Laser, Skin and Vein Institute

Hunt Valley, Maryland, 21030, United States

Location

Skin Care Physicians of Chestnut Hill

Chestnut Hill, Massachusetts, 02467, United States

Location

Zel Skin and Laser Specialist LLC

Edina, Minnesota, 55424, United States

Location

MeSH Terms

Interventions

Lipectomy

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Bariatric Surgery; Bariatrics; Obesity Management; Surgical Procedures, Operative; Plastic Surgery Procedures

Results Point of Contact

• Title: Kerrie Jiang, Executive Director Regulatory, Clinical and Medical Affairs
• Organization: Zeltiq Aesthetics

kerrie.jiang@allergan.com

(925) 621-7462

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2010
• First Posted: April 12, 2010
• Study Start: March 30, 2010
• Primary Completion: September 28, 2010
• Study Completion: December 8, 2010
• Last Updated: December 21, 2020
• Results First Posted: December 21, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)