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Evaluation of CoolSculpt Combining Venus Legacy Technology for Enhanced Results in Fat Reduction & Laxity of the Flanks

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: NCT02569112
Recruitment Status : Completed
First Posted : October 6, 2015
Results First Posted : June 18, 2018
Last Update Posted : June 18, 2018
Sponsor:
Information provided by (Responsible Party):
Venus Concept

Tracking Information
First Submitted Date  ICMJE August 24, 2015
First Posted Date  ICMJE October 6, 2015
Results First Submitted Date  ICMJE December 1, 2017
Results First Posted Date  ICMJE June 18, 2018
Last Update Posted Date June 18, 2018
Study Start Date  ICMJE August 2015
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2018)
General Improvement in Skin Laxity of the Flank Area [ Time Frame: 6 months ]
Independent reviewer to identify the six month post-treatment photograph of the flank area treated with multi-polar radiofrequency, pulsed electro-magnetic fields and vacuum suction using the Global Aesthetic Improvement Scale (GAIS) where 3 = very much improved, 2 = much improved, 1 = improved, 0 = no change, -1 = worse, -2 = Much worse and -3 = very much worse.
Original Primary Outcome Measures  ICMJE
 (submitted: October 2, 2015)
Visual Improvement [ Time Frame: 6 months ]
Comparing the two flanks in a photographic display and grading them on a 7 point scale 3 Very Much Improved 2 Much Improved 1 Improved 0 No Change
  • 1 Worse
  • 2 Much Worse
  • 3 Very Much Worse
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of CoolSculpt Combining Venus Legacy Technology for Enhanced Results in Fat Reduction & Laxity of the Flanks
Official Title  ICMJE Prospective Internally Controlled Blind Reviewed Clinical Evaluation of Cryolipolysis Combined With MP2 Technology for Enhanced Subject Results in Circumferential Fat Reduction and Skin Laxity of the Flanks
Brief Summary The purpose of this study is to evaluate the effect on the subject outcome using the combination of the Zeltiq Cryolipolysis device and the Venus Concept multipolar radiofrequency device with varipulse technology for the enhanced non-surgical treatment of skin laxity in the flank area.
Detailed Description

Commercially available as the Zeltiq CoolSculpting system, cryolipolysis is FDA cleared for use in the United States for an indication of fat layer reduction in the flanks, thighs, and abdomen through cold-assisted lipolysis. CoolSculpting has been clinically proven to non-surgically reduce subcutaneous fat bulges, allowing patients to achieve noticeable and measurable aesthetic results without the pain, expense, downtime, and risks associated with existing invasive and minimally-invasive procedures. The Zeltiq CoolSculpting System is a non-invasive device designed to cool subcutaneous fat without affecting adjacent or underlying structures.

The RF device to be used in this study is a FDA cleared device used for aesthetic non-surgical skin tightening procedures including wrinkles, skin rhytides and cellulite in the face and body. The Venus Legacy utilizes a multi-polar radiofrequency system to deliver homogenous heating to multiple tissue depths. The Venus Legacy device also utilizes pulsed magnetic field technology as well as pulsed negative pressure technology.

The flanks of Ten (10) healthy adults (male and female), 21 to 50 years of age, who desire a reduction in focal fat of the flanks will be recruited from the investigator's subject populations. Informed Consent will be obtained from each subject during a screening visit.

The photos will be taken prior to the treatment series, one week post treatment series, at 3 and 6 months post treatment series for the evaluation of two blinded reviewers as well as for the investigator to assess.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:
All participants to receive cryolipolysis treatment on one side of their body and cryolipolysis plus multipolar radiofrequency with varipulse technology treatment on the other side of their body.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description:
Both investigator and independent reviewer to determine which side of the body the multi-polar radiofrequency, pulsed-electromagnetic fields and vacuum therapy was applied.
Primary Purpose: Treatment
Condition  ICMJE Adipose Tissue
Intervention  ICMJE
  • Device: multipolar RF, varipulse
    Multi-polar Radio frequency (RF) technology combining pulsed electro magnetic fields (PEMF) and mild suction stimulation (varipulse).
    Other Name: Venus Legacy
  • Device: cryolipolysis
    Cryolipolysis technology uses the sensitivity of fat cells to cold injury, causing them to freeze and undergo cellular apoptosis.
    Other Name: CoolSculpt
Study Arms  ICMJE
  • Active Comparator: cryolipolysis
    Each patient is their own control and one side will have only a cryolipolysis treatment while the other side will have a cryolipolysis treatment plus multipolar radiofrequency and varipulse treatment.
    Intervention: Device: cryolipolysis
  • Experimental: cryolipolysis, multipolar RF, varipulse
    Each patient is their own control and one side will have only a cryolipolysis treatment while the other side will have a cryolipolysis treatment plus multipolar radiofrequency and varipulse treatment.
    Interventions:
    • Device: multipolar RF, varipulse
    • Device: cryolipolysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 2, 2015)
10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects who can read, understand, and sign the Informed Consent Form.
  • Subjects willing and able to comply with all study requirements.
  • Subjects who have pre-scheduled a body contouring procedure.
  • Subjects have clearly visible fat on the flanks, which in the investigator's opinion, may benefit from the treatment.
  • Subjects have not had weight change exceeding 10 pounds in the preceding month.
  • Subjects agree 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.

Exclusion Criteria:

  • Subjects with active localized or systemic infections.
  • Immuno-compromised subjects.
  • Pregnant and/or lactating (All female volunteers will be advised about using birth control during the period of study).
  • In the opinion of the trained clinician, subject is unwilling or unable to adhere to all study requirements, including application and follow-up visits.
  • Subjects with a history of radiation therapy to the treatment area.
  • Subjects with any skin pathology or condition that could interfere with evaluation or with the use of typical ancillary medical treatments or care used before, during or after treatments.
  • 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 any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites that may interfere with the treatment or evaluation (stretch marks is not an exclusion).
  • Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system
  • Subject has a history of hernia in the areas to be treated.
  • Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02569112
Other Study ID Numbers  ICMJE CS0915
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Venus Concept
Study Sponsor  ICMJE Venus Concept
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Julius Few, MD Few Institute
PRS Account Venus Concept
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP