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DualSculpting the Upper Arms (ARM)

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ClinicalTrials.gov Identifier: NCT02939105
Recruitment Status : Completed
First Posted : October 19, 2016
Last Update Posted : June 22, 2017
Sponsor:
Information provided by (Responsible Party):
Zeltiq Aesthetics

Brief Summary:
Evaluate the safety and efficacy of the ZELTIQ CoolSculpting System using specialized vacuum applicators for non-invasive subcutaneous fat reduction of the upper arms.

Condition or disease Intervention/treatment Phase
Body Fat Disorder Device: The ZELTIQ System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: DualSculpting the Upper Arms Using Vacuum Applicators and a Customized Treatment Approach
Actual Study Start Date : December 2, 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Arm Intervention/treatment
Experimental: Fat Reduction
The treatments are designed to see if the fat, on the upper arm, can be reduced.
Device: The ZELTIQ System
The CoolSculpting machine will be used to perform the treatments.




Primary Outcome Measures :
  1. Blinded independent review of photographs to assess change in visible arm fat between baseline (pre-treatment) and 12 weeks post treatment. [ Time Frame: 12 weeks post treatment ]
    The primary efficacy endpoint of the study will be determined by correct identification of baseline (pre-treatment) vs. 12 weeks post-final treatment photographs by at least two out of three blinded, independent reviewers. Success will be defined as at least 70% correct identification of the baseline (pre-treatment) photographs.



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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): NCT02939105


Locations
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Canada, British Columbia
Pacific Dermaesthetics
Vancouver, British Columbia, Canada, V6E 4M3
Sponsors and Collaborators
Zeltiq Aesthetics
Investigators
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Principal Investigator: Jason Rivers, MD Pacific Dermaesthetics

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Responsible Party: Zeltiq Aesthetics
ClinicalTrials.gov Identifier: NCT02939105     History of Changes
Other Study ID Numbers: ZA16-005
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: June 22, 2017
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Lipid Metabolism Disorders
Metabolic Diseases