Outer Thigh Study With Varied Treatment Parameters

NCT02081209 | Completed Results FDA Device

• 1 other identifier: ZA14-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to compare the performance of the Zeltiq CoolSculpting System using various treatment parameters for non-invasive reduction of subcutaneous fat in the lateral thighs.

Conditions

Body Fat Disorder

Keywords

Lipolysis; Cryolipolysis; Fat Reduction

Outcome Measures

Primary Outcomes (3)

• Safety of the Zeltiq Device

  The number of device- or procedure-related adverse events will be tabulated from the time of enrollment through the 16 week follow-up visit.

  Time of enrollment though16 weeks post-treatment (approximately 5 months)

• Safety of the Zeltiq Device

  The number of unanticipated adverse device effects (UADEs) will be tabulated.

  From enrollment through 16 week follow-up (approximately 5 months)

• Percentage 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. Criteria for evaluable photos for the purposes of the independent review: subject completed treatment regimen; subject has complete set of baseline photos; subject has a complete set of post-treatment photos; photos were taken using Zeltiq standard procedure. The expected success rate is 80%.

  Baseline and 16 weeks post-treatment

Secondary Outcomes (2)

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

  16 weeks post-treatment

• Subject Satisfaction

  16-weeks post treatment

Study Arms (1)

Lateral Thigh Treatment Group

EXPERIMENTAL

All subjects were treated on both thighs with the CoolSculpting System. One lateral thigh was treated using a protocol-defined temperature for 120 minutes. The contralateral thigh was treated at a protocol defined temperature for 60 minutes for 18 subjects. Twenty-two subjects were treated on the contralateral outer thigh with a 3rd protocol-defined temperature for 60 minutes.

Device: The Zeltiq CoolSculpting System

Interventions

The Zeltiq CoolSculpting System DEVICE

Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.

Also known as: Cryolipolysis

Lateral Thigh Treatment Group

Eligibility Criteria

• Age: 18 Years - 65 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 and \< 65 years of age.
• Subject has clearly visible fat on the intended treatment area (lateral thighs), 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 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.
• 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 2 months.
• Subject has significant asymmetry between the lateral thighs.
• 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 (2)

Marina Plastic Surgery

Marina del Rey, California, 90292, United States

Location

Innovation Research Center

Pleasanton, California, 94588, United States

Location

Results Point of Contact

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

kerrie.jiang@allergan.com

(925) 621-7462

Study Officials

• Eric Bachelor, MD

  Innovation Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

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

Model Details: All subjects to be treated on one lateral thigh at a protocol-defined temperature for 120 minutes. Treatment of the contralateral thigh was performed using two unique protocol-defined temperatures for 60 minutes.

Study Record Dates

• First Submitted: March 4, 2014
• First Posted: March 7, 2014
• Study Start: February 4, 2014
• Primary Completion: October 21, 2014
• Study Completion: October 21, 2014
• Last Updated: May 21, 2025
• Results First Posted: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)