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
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Sponsor:
Venus Concept
Information provided by (Responsible Party):
Venus Concept
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Study Type | Interventional |
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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 |
Participant Flow
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 | |||
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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.
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Baseline Characteristics
Arm/Group Title | Cryolipolysis Treatment & Cryolipolysis With Legacy | |
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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 | |
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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.
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 10 participants | |
<=18 years |
0 0.0%
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Between 18 and 65 years |
10 100.0%
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>=65 years |
0 0.0%
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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.
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 10 participants |
10 |
Outcome Measures
Adverse Events
Limitations and Caveats
This was a pilot study to evaluate the treatment combination.
More Information
Results Point of Contact
Name/Title: | Dr. Yoni Iger |
Organization: | Venus Concept Ltd. |
Phone: | 8889070115 |
EMail: | yoni@venusconcept.com |
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 |