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

• 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: Venus Concept
• Information provided by (Responsible Party): Venus Concept

Tracking Information

• First Submitted Date: August 24, 2015
• First Posted Date: October 6, 2015
• Results First Submitted Date: December 1, 2017
• Results First Posted Date: June 18, 2018
• Last Update Posted Date: June 18, 2018
• Study Start Date: August 2015
• Actual Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evaluation of CoolSculpt Combining Venus Legacy Technology for Enhanced Results in Fat Reduction & Laxity of the Flanks
• Official Title: 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: Interventional
• Study Phase: Not Applicable

Study Design

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: Adipose Tissue

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 2, 2015): 10
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: October 2016
• Actual Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 21 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02569112
• Other Study ID Numbers: CS0915
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Venus Concept
• Study Sponsor: Venus Concept
• Collaborators: Not Provided

Investigators

• Principal Investigator: Julius Few, MD; Few Institute

• PRS Account: Venus Concept
• Verification Date: December 2017