Trial Outcomes & Findings for Evaluation of CoolSculpt Combining Venus Legacy Technology for Enhanced Results in Fat Reduction & Laxity of the Flanks (NCT NCT02569112)
NCT ID: NCT02569112
Last Updated: 2018-06-18
Results Overview
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.
COMPLETED
NA
10 participants
6 months
2018-06-18
Participant Flow
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.
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.
Unit of analysis: flanks
Participant milestones
| Measure |
Cyrolipolysis
Each side of the subject received a cryolipolysis treatment.
|
Cryolipolysis, Multipolar RF With Varipulse Technology
One side of the body received cryolipolysis plus multipolar radiofrequency with varipulse technology
|
|---|---|---|
|
Overall Study
STARTED
|
10 20
|
10 10
|
|
Overall Study
COMPLETED
|
10 20
|
10 10
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of CoolSculpt Combining Venus Legacy Technology for Enhanced Results in Fat Reduction & Laxity of the Flanks
Baseline characteristics by cohort
| Measure |
Cryolipolysis Treatment & Cryolipolysis With Legacy
n=20 flanks
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=10 Participants
|
|
Sex/Gender, Customized
Female
|
9 participants
n=10 Participants
|
|
Sex/Gender, Customized
Male
|
1 participants
n=10 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 6 monthsIndependent 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.
Outcome measures
| Measure |
Cryolipolysis Treatment & Cryolipolysis With Legacy
n=20 flank
Each patient is their own control and one side will have only a cryolypolysis (Coolsculpt) treatment
|
|---|---|
|
General Improvement in Skin Laxity of the Flank Area
Reviewer Cryoliposis GAIS at 6 month follow-up
|
1.1 units on a scale
Standard Deviation 1.0
|
|
General Improvement in Skin Laxity of the Flank Area
Reviewer Cryolipolysis & RF, PEMF & varipulse GAIS
|
2.1 units on a scale
Standard Deviation 1.0
|
Adverse Events
ONE DEVICE USED - CoolSculpt Flank Side
TWO DEVICES USED - CoolSculpt and Venus Legacy Flank Side
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ONE DEVICE USED - CoolSculpt Flank Side
n=10 participants at risk
Each patient is their own control and one side will have only a cryolypolysis (Coolsculpt) treatment
|
TWO DEVICES USED - CoolSculpt and Venus Legacy Flank Side
n=10 participants at risk
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
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Modest heat sensation
|
0.00%
0/10 • Adverse events were collected for 11 months and 1 day.
|
70.0%
7/10 • Number of events 7 • Adverse events were collected for 11 months and 1 day.
|
|
Skin and subcutaneous tissue disorders
Modest erythema
|
0.00%
0/10 • Adverse events were collected for 11 months and 1 day.
|
40.0%
4/10 • Number of events 4 • Adverse events were collected for 11 months and 1 day.
|
|
Skin and subcutaneous tissue disorders
modest edema
|
0.00%
0/10 • Adverse events were collected for 11 months and 1 day.
|
10.0%
1/10 • Number of events 1 • Adverse events were collected for 11 months and 1 day.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place