Non-Invasive Reduction of Fat in the Inner Thighs

NCT01517659 | Completed Results FDA Device

• 1 other identifier: ZA12-002
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 3

Brief Summary

Evaluate the safety and efficacy of non-invasive fat reduction in the inner thighs with the ZELTIQ CoolSculpting System.

Conditions

Body Fat Disorder

Keywords

Cryolipolysis; Fat Reduction

Outcome Measures

Primary Outcomes (2)

• Percentage of Pre-Treatment Images Correctly Identified by 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 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 at least 80% correct identification of pre-treatment images and the majority of physician reviewers (2 out 3) correctly identify 75% of the pre-treatment images.

  16 weeks post-treatment

• Safety of the CoolSculpting Device and/or Procedure

  The number of device- or procedure related adverse events will be tabulated. Adverse event data are collected continuously throughout the study period from the time of enrollment through the 16 week follow-up visit. At the time of an AE report, each study investigator determines the relationship to the investigational device or the study procedure.

  Enrollment through 16 weeks post-treatment

Secondary Outcomes (2)

• Subject Satisfaction

  16 weeks post-treatment

• Reduction in Fat Layer Thickness in the Treated Area as Measured by Ultrasound

  16 week-post-treatment

Study Arms (1)

Fat Reduction

EXPERIMENTAL

The Zeltiq CoolSculpting System will be used to treat subcutaneous fat on each inner thigh.

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

Fat Reduction

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 inner thighs and 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 his/her 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, abdominoplasty, 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 6 months.
• Subject needs to administer, or has a known history of, subcutaneous injections (e.g., heparin, insulin) into the area of intended treatment 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 a 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 intends to become pregnant in the next 8 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 (3)

Laser & Skin Surgery Center of Northern California

Sacramento, California, 95816, United States

Location

Zel Skin and Laser Specialists

Edina, Minnesota, 55424, United States

Location

Dallas Plastic Surgery Institute

Dallas, Texas, 75231, United States

Location

Related Publications (1)

• Zelickson BD, Burns AJ, Kilmer SL. Cryolipolysis for safe and effective inner thigh fat reduction. Lasers Surg Med. 2015 Feb;47(2):120-7. doi: 10.1002/lsm.22320. Epub 2015 Jan 13.

  PMID: 25586980 RESULT

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

• Suzanne Kilmer, MD

  Laser and Skin Surgery Center of Northern California

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Panel of blinded physicians evaluated photos of pre-treatment and post-treatment images. Reviewers were blinded to the time point images were collected.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2012
• First Posted: January 25, 2012
• Study Start: December 1, 2012
• Primary Completion: February 12, 2014
• Study Completion: October 1, 2014
• Last Updated: December 3, 2021
• Results First Posted: November 17, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)