CoolSculpting of the Flank With Alternate Treatment Parameters

NCT02081196 | Completed Results FDA Device

• 1 other identifier: ZA13-005
• Study Type: interventional
• Target: 45
• Locations: 2 countries
• Sites: 3

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction with an alternative treatment parameter.

Conditions

Body Fat Disorder

Keywords

Lipolysis; Cryolipolysis; Fat Reduction

Outcome Measures

Primary Outcomes (2)

• The Number of Device and/or Procedure-Related Adverse Events

  The number of device- or procedure-related adverse events will be tabulated. Adverse event reports are collected throughout the study from enrollment through the 16 week follow-up visit. The investigator determines if there is a relationship between the event and the study device or procedure.

  Enrollment through 16 weeks post-treatment visit, which is approximately 5 months

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

  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 untreated contralateral flank 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. Success is defined as, on average, at least a 1mm or greater reduction in fat layer thickness for the treated flank as compared to the untreated control flank. Results indicate the fat layer reduction in millimeters.

  Pre-treatment and 16 weeks post-treatment

Secondary Outcomes (2)

• Proportion of Pre-treatment Images Correctly Identified.

  16 weeks post-treatment

• Subject Satisfaction

  16 weeks post-treatment

Study Arms (1)

CoolSculpting of the Flank With Alternate Treatment Parameters

EXPERIMENTAL

Each subject served as their own control with 1 flank treated with CoolSculpting; the contralateral flank was untreated.

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, Lipolysis

CoolSculpting of the Flank With Alternate Treatment Parameters

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 flanks, 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 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 has a history of hernia in the areas to be treated.
• 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

Dallas Plastic Surgery Institute

Dallas, Texas, 75231, United States

Location

Arbutus Laser Centre

Vancouver, British Columbia, V6JIZ6, Canada

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

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
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2014
• First Posted: March 7, 2014
• Study Start: February 18, 2014
• Primary Completion: June 27, 2014
• Study Completion: June 27, 2014
• Last Updated: March 1, 2021
• Results First Posted: March 1, 2021

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); CA (1)