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

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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

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Adipose Tissue
Interventions Device: multipolar RF, varipulse
Device: cryolipolysis
Enrollment 10
Recruitment Details Ten subjects between the ages of 21 and 50 years of age, requesting a reduction in focal fat of the flanks were recruited from a single outpatient clinic.
Pre-assignment Details Subjects received one session of cryolipolysis treatment on both sides of their body before one side of their body was treated with multipolar radiofrequency plus varipulse technology. Each subject acted as their own control.
Arm/Group Title Cyrolipolysis Cryolipolysis, Multipolar RF With Varipulse Technology
Hide Arm/Group Description Each side of the subject received a cryolipolysis treatment. One side of the body received cryolipolysis plus multipolar radiofrequency with varipulse technology
Period Title: Overall Study
Number of participants Number of units (flanks) Number of participants Number of units (flanks)
Started 10 20 10 10
Completed [1] 10 20 10 [2] 10
Not Completed 0 0 0 0
[1]
Each subject received a single cryolipolysis treatment on both sides of their body.
[2]
Each subject received multipolar RF with varipulse technology to only one side of their body.
Arm/Group Title Cryolipolysis Treatment & Cryolipolysis With Legacy
Hide Arm/Group Description Each patient is their own control. Both flanks will be treated with cryolypolysis. The flank will be divided into two equal treatment areas where one side will receive multipolar radiofrequency with varipulse technology treatment and the other side will not.
Overall Number of Baseline Participants 10
Overall Number of Units Analyzed
Type of Units Analyzed: Flanks
20
Hide Baseline Analysis Population Description
Each subject received a cryolipolysis treatment to both sides of body. One side of the flank will then receive multipolar RF and PEMF with Varipulse technology and the other side will not.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
10
 100.0%
>=65 years
0
   0.0%
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants
Female 9
Male 1
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
1.Primary Outcome
Title General Improvement in Skin Laxity of the Flank Area
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cryolipolysis Treatment & Cryolipolysis With Legacy
Hide Arm/Group Description:
Each patient is their own control and one side will have only a cryolypolysis (Coolsculpt) treatment
Overall Number of Participants Analyzed 10
Overall Number of Units Analyzed
Type of Units Analyzed: Flank
20
Mean (Standard Deviation)
Unit of Measure: units on a scale
Reviewer Cryoliposis GAIS at 6 month follow-up 1.1  (1.0)
Reviewer Cryolipolysis & RF, PEMF & varipulse GAIS 2.1  (1.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cryolipolysis Treatment & Cryolipolysis With Legacy
Comments The null hypothesis was that the addition of the multipolar radiofrequency with varipulse technology treatment to the cryolipolysis treatment would not show visual improvement.
Type of Statistical Test Superiority
Comments A significant improvement in skin laxity reduction is defined as a mean average increase in grade of 1 as per the GAIS.
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Used Wilcoxon Matched-Pairs Signed-Ranks test
Time Frame Adverse events were collected for 11 months and 1 day.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ONE DEVICE USED - CoolSculpt Flank Side TWO DEVICES USED - CoolSculpt and Venus Legacy Flank Side
Hide Arm/Group Description Each patient is their own control and one side will have only a cryolypolysis (Coolsculpt) treatment Each patient is their own control and one side will have only a cryolypolysis (Coolsculpt) treatment while the other side will have both a cryolypolysis treatment and an RF, PEMF and Varipulse (Venus Legacy) treatment
All-Cause Mortality
ONE DEVICE USED - CoolSculpt Flank Side TWO DEVICES USED - CoolSculpt and Venus Legacy Flank Side
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)      0/10 (0.00%)    
Hide Serious Adverse Events
ONE DEVICE USED - CoolSculpt Flank Side TWO DEVICES USED - CoolSculpt and Venus Legacy Flank Side
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/10 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ONE DEVICE USED - CoolSculpt Flank Side TWO DEVICES USED - CoolSculpt and Venus Legacy Flank Side
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      7/10 (70.00%)    
Skin and subcutaneous tissue disorders     
Modest heat sensation  1  0/10 (0.00%)  0 7/10 (70.00%)  7
Modest erythema  1  0/10 (0.00%)  0 4/10 (40.00%)  4
modest edema  1  0/10 (0.00%)  0 1/10 (10.00%)  1
1
Term from vocabulary, MedDRA (18.0)
Indicates events were collected by systematic assessment
This was a pilot study to evaluate the treatment combination.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Yoni Iger
Organization: Venus Concept Ltd.
Phone: 8889070115
EMail: yoni@venusconcept.com
Layout table for additonal information
Responsible Party: Venus Concept
ClinicalTrials.gov Identifier: NCT02569112    
Other Study ID Numbers: CS0915
First Submitted: August 24, 2015
First Posted: October 6, 2015
Results First Submitted: December 1, 2017
Results First Posted: June 18, 2018
Last Update Posted: June 18, 2018