CoolSculpting the Upper Arm Study

NCT02669329 | Completed Results FDA Device

• 1 other identifier: ZA15-005
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

Evaluate the safety and efficacy of the ZELTIQ CoolSculpting System using a specialized surface applicator for non-invasive subcutaneous fat reduction in the upper arm.

Conditions

Body Fat Disorder

Outcome Measures

Primary Outcomes (2)

• 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. The review panel will consist of 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. Correct identification of photos by at least 2 of the 3 reviewers has an expected success rate of 75%.

  12 weeks post treatment

• Safety of the CoolSculpting Device in Upper Arm Treatments

  The incidence of reported unanticipated adverse device effects (UADE) from the time of enrollment through the 12-week follow-up visit will be collected and analyzed. It is expected there will be zero UADE's reported.

  12 weeks post-treatment

Study Arms (1)

Upper arm treatment with vacuum applicator

EXPERIMENTAL

Subjects with clearly visible fat sufficient for treatment received bilateral CoolSculpting treatments, 1 treatment on each arm.

Device: CoolSculpting device with vacuum applicator.

Interventions

CoolSculpting device with vacuum applicator. DEVICE

The CoolSculpting device with a vacuum applicator will be used to perform the treatments.

Upper arm treatment with vacuum 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 sufficient for treatment on the upper arm, which in the investigator's opinion, may benefit from the treatment.
• No weight change exceeding 5% in the preceding month.
• 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 the study written informed consent form.

You may not qualify if:

• History of a fat reduction procedure (e.g., liposuction, surgery, lipolytic agents, etc.), or implants in or adjacent to the area of intended treatment.
• History of prior surgery in the arms.
• Known history of cryoglobulinemia, cold urticaria, cold agglutinin disease, or paroxysmal cold hemoglobinuria.
• Known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
• History of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
• History of carpal tunnel syndrome, compartment syndrome or deep vein thrombosis in the upper extremities.
• Currently taking or has taken diet pills or weight control supplements within the past month.
• Any dermatological conditions, such as scars, infection, in the location of the treatment area that may interfere with the treatment or evaluation.
• Active implanted device such as a pacemaker, defibrillator, or drug delivery system.
• Pregnant or intending to become pregnant in the next 5 months.
• Lactating or has been lactating in the past 6 months.
• Unable or unwilling to comply with the study requirements.
• 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)

Dr. Jean Carruthers Cosmetic Surgery Inc.

Vancouver, British Columbia, V5Z 4E1, Canada

Location

Pacific Dermaesthetics

Vancouver, British Columbia, V6E 4M3, Canada

Location

Related Publications (1)

• Carruthers JD, Humphrey S, Rivers JK. Cryolipolysis for Reduction of Arm Fat: Safety and Efficacy of a Prototype CoolCup Applicator With Flat Contour. Dermatol Surg. 2017 Jul;43(7):940-949. doi: 10.1097/DSS.0000000000001134.

  PMID: 28595246 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

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 21, 2016
• First Posted: February 1, 2016
• Study Start: February 5, 2016
• Primary Completion: June 7, 2016
• Study Completion: June 7, 2016
• Last Updated: November 4, 2021
• Results First Posted: September 17, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)