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CoolSculpting the Upper Arm Study (ARM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02669329
Recruitment Status : Completed
First Posted : February 1, 2016
Results First Posted : September 17, 2020
Last Update Posted : September 17, 2020
Sponsor:
Information provided by (Responsible Party):
Zeltiq Aesthetics

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.

Condition or disease Intervention/treatment Phase
Body Fat Disorder Device: CoolSculpting device with vacuum applicator. Not Applicable

Detailed Description:
This multi-center trial will evaluate the Zeltiq CoolSculpting treatment to perform treatments in the upper arm for the reduction subcutaneous fat reduction.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: CoolSculpting the Upper Arm Using a Vacuum Applicator
Actual Study Start Date : February 5, 2016
Actual Primary Completion Date : June 7, 2016
Actual Study Completion Date : June 7, 2016

Arm Intervention/treatment
Experimental: Upper arm treatment with vacuum applicator
Subjects with clearly visible fat sufficient for treatment received bilateral CoolSculpting treatments, 1 treatment on each arm.
Device: CoolSculpting device with vacuum applicator.
The CoolSculpting device with a vacuum applicator will be used to perform the treatments.




Primary Outcome Measures :
  1. Percentage of Pre-treatment Images Correctly Identified [ Time Frame: 12 weeks post treatment ]
    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%.

  2. Safety of the CoolSculpting Device in Upper Arm Treatments [ Time Frame: 12 weeks post-treatment ]
    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.



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Ages Eligible for Study:   22 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02669329


Locations
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Canada, British Columbia
Dr. Jean Carruthers Cosmetic Surgery Inc.
Vancouver, British Columbia, Canada, V5Z 4E1
Pacific Dermaesthetics
Vancouver, British Columbia, Canada, V6E 4M3
Sponsors and Collaborators
Zeltiq Aesthetics
Publications of Results:
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Responsible Party: Zeltiq Aesthetics
ClinicalTrials.gov Identifier: NCT02669329    
Other Study ID Numbers: ZA15-005
First Posted: February 1, 2016    Key Record Dates
Results First Posted: September 17, 2020
Last Update Posted: September 17, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Lipid Metabolism Disorders
Metabolic Diseases