CoolSculpting of the Distal Thigh Study

NCT02335749 | Completed Results FDA Device

• 1 other identifier: ZA14-004
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

Brief Summary

Evaluate the safety and efficacy of the ZELTIQ CoolSculpting System using a small area applicator for non-invasive subcutaneous fat reduction in the distal thigh.

Conditions

Body Fat Disorder

Outcome Measures

Primary Outcomes (2)

• Rate of Device- or Procedure-related Adverse Events

  The number of device- or procedure-related adverse events will be tabulated. Adverse event data are collected throughout the study period from the time of enrollment through the final follow-up visit.

  Study enrollment through 12-week final follow-up visit, approximately 15 weeks

• 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. 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. Note: Due to the inconsistency of site photographic practices, the photos were not reasonably evaluable and therefore the independent phot review was not conducted.

  12 weeks post final treatment

Study Arms (1)

Treatment with Small Area Applicator

EXPERIMENTAL

Each enrolled subject was treated on a single thigh, in the distal region.

Device: The ZELTIQ System

Interventions

The ZELTIQ System DEVICE

The CoolSculpting System with a Small Area Applicator will be used to deliver treatments.

Also known as: CoolSculpting System

Treatment with Small Area Applicator

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects \> 22 years of age and \< 65 years of age.
• Subject has clearly visible fat on the distal thigh, which in the investigator's opinion, may benefit from the treatment.
• Subject has not had weight change exceeding 10 pounds in the preceding month.
• Subject with body mass index (BMI) up to 30. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.
• Subject agrees to maintain his/her weight (i.e., within 5% of total body weight) by not making any major changes in their diet or exercise routine 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.
• Subject has had an invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the area of intended treatment.
• Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 12 months.
• 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.
• Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
• 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.
• 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 is taking or has taken diet pills or supplements within the past month.
• Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system
• Subject is pregnant or intending to become pregnant during the study period (in the next 5 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 (4)

Bowes Dermatology Group

Miami, Florida, 33133, United States

Location

SkinCare Physicians of Chestnut Hill

Chestnut Hill, Massachusetts, 02467, United States

Location

Laser & Skin Surgery Center of New York

New York, New York, 10016, United States

Location

Nashville Centre for Laser and Facial Surgery

Nashville, Tennessee, 37203, United States

Location

Results Point of Contact

• Title: Kerrie Jiang, Director Clinical 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: January 7, 2015
• First Posted: January 12, 2015
• Study Start: December 17, 2014
• Primary Completion: November 9, 2015
• Study Completion: November 9, 2015
• Last Updated: December 1, 2021
• Results First Posted: December 1, 2021

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)