Back to resultsCoolSculpting the Upper Arm Study (ARM)
Primary Purpose
Body Fat Disorder
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
CoolSculpting device with vacuum applicator.
Sponsored by
About this trial
This is an interventional other trial for Body Fat Disorder
Eligibility 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.
Sites / Locations
- Dr. Jean Carruthers Cosmetic Surgery Inc.
- Pacific Dermaesthetics
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Upper arm treatment with vacuum applicator
Arm Description
Subjects with clearly visible fat sufficient for treatment received bilateral CoolSculpting treatments, 1 treatment on each arm.
Outcomes
Primary Outcome Measures
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%.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02669329
Brief Title
CoolSculpting the Upper Arm Study
Acronym
ARM
Official Title
CoolSculpting the Upper Arm Using a Vacuum Applicator
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
February 5, 2016 (Actual)
Primary Completion Date
June 7, 2016 (Actual)
Study Completion Date
June 7, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zeltiq Aesthetics
4. Oversight
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Fat Disorder
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Upper arm treatment with vacuum applicator
Arm Type
Experimental
Arm Description
Subjects with clearly visible fat sufficient for treatment received bilateral CoolSculpting treatments, 1 treatment on each arm.
Intervention Type
Device
Intervention Name(s)
CoolSculpting device with vacuum applicator.
Intervention Description
The CoolSculpting device with a vacuum applicator will be used to perform the treatments.
Primary Outcome Measure Information:
Title
Percentage of Pre-treatment Images Correctly Identified
Description
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%.
Time Frame
12 weeks post treatment
Title
Safety of the CoolSculpting Device in Upper Arm Treatments
Description
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.
Time Frame
12 weeks post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Dr. Jean Carruthers Cosmetic Surgery Inc.
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E1
Country
Canada
Facility Name
Pacific Dermaesthetics
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6E 4M3
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28595246
Citation
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.
Results Reference
result
Learn more about this trial
CoolSculpting the Upper Arm Study
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