Trial Outcomes & Findings for Clinical Evaluation of Venus Versa Octipolar Applicator for Reduction of Abdomen Circumference (NCT NCT02492997)
NCT ID: NCT02492997
Last Updated: 2020-11-17
Results Overview
Abdominal circumference measurement of the treated area at 1 month after the last treatment performed by controlled tape measurement
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
44 participants
Primary outcome timeframe
1 month post treatment series
Results posted on
2020-11-17
Participant Flow
Enrollment was opened in March 2015. By time of study closure in October 106, only 44 of the planned 60 subjects had been enrolled to the study. As such, the trial was terminated due to slow enrollment.
Two subjects were reported to have been screen failed.
Participant milestones
| Measure |
Treatment Group
Group treated with the active Venus Versa octipolar applicator and the glycerin gel.
Venus Versa: The Venus Versa system is a console that supports an applicators that simultaneously emits radio frequency (RF) and a Pulsed Magnetic Field (PEMF). This combination of energy can raise the temperature of treatment area quickly and homogeneously. The Pulsed Magnetic Field is induced by short pulses of electrical current through coil in the applicator. The magnetic field penetrates into the skin and results in Foucault (Eddy) electrical currents around the cell membranes of the treated tissues. Foucault currents change the electrical potential of charged receptors on the bi-lipid cell membrane layer of dermal cells, which results in the stimulation of molecular and cellular activities and reactions.
Glycerine gel: Gel used to protect the skin from the RF energy and to assist with energy distribution
|
Control Group
Group treated with the inactive Venus Versa octipolar applicator and the glycerin gel.
Venus Versa: The Venus Versa system is a console that supports an applicators that simultaneously emits radio frequency (RF) and a Pulsed Magnetic Field (PEMF). This combination of energy can raise the temperature of treatment area quickly and homogeneously. The Pulsed Magnetic Field is induced by short pulses of electrical current through coil in the applicator. The magnetic field penetrates into the skin and results in Foucault (Eddy) electrical currents around the cell membranes of the treated tissues. Foucault currents change the electrical potential of charged receptors on the bi-lipid cell membrane layer of dermal cells, which results in the stimulation of molecular and cellular activities and reactions.
Glycerine gel: Gel used to protect the skin from the RF energy and to assist with energy distribution
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
21
|
|
Overall Study
COMPLETED
|
19
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Treatment Group
Group treated with the active Venus Versa octipolar applicator and the glycerin gel.
Venus Versa: The Venus Versa system is a console that supports an applicators that simultaneously emits radio frequency (RF) and a Pulsed Magnetic Field (PEMF). This combination of energy can raise the temperature of treatment area quickly and homogeneously. The Pulsed Magnetic Field is induced by short pulses of electrical current through coil in the applicator. The magnetic field penetrates into the skin and results in Foucault (Eddy) electrical currents around the cell membranes of the treated tissues. Foucault currents change the electrical potential of charged receptors on the bi-lipid cell membrane layer of dermal cells, which results in the stimulation of molecular and cellular activities and reactions.
Glycerine gel: Gel used to protect the skin from the RF energy and to assist with energy distribution
|
Control Group
Group treated with the inactive Venus Versa octipolar applicator and the glycerin gel.
Venus Versa: The Venus Versa system is a console that supports an applicators that simultaneously emits radio frequency (RF) and a Pulsed Magnetic Field (PEMF). This combination of energy can raise the temperature of treatment area quickly and homogeneously. The Pulsed Magnetic Field is induced by short pulses of electrical current through coil in the applicator. The magnetic field penetrates into the skin and results in Foucault (Eddy) electrical currents around the cell membranes of the treated tissues. Foucault currents change the electrical potential of charged receptors on the bi-lipid cell membrane layer of dermal cells, which results in the stimulation of molecular and cellular activities and reactions.
Glycerine gel: Gel used to protect the skin from the RF energy and to assist with energy distribution
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Gained Weight
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Thirty-nine subjects signed consent. Only thirty CRFs were returned to sponsor on closure of study. Remaining nine CRFs were assumed to be lost.
Baseline characteristics by cohort
| Measure |
Treatment Group
n=19 Participants
Group treated with the active Venus Versa octipolar applicator and the glycerin gel.
|
Control Group
n=20 Participants
Group treated with the inactive Venus Versa octipolar applicator and the glycerin gel.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=19 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=19 Participants
|
20 Participants
n=20 Participants
|
39 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=19 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=39 Participants
|
|
Sex/Gender, Customized
Unknown
|
19 participants
n=19 Participants
|
20 participants
n=20 Participants
|
39 participants
n=39 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=19 Participants
|
20 participants
n=20 Participants
|
39 participants
n=39 Participants
|
|
Abdominal circumference
|
91.47 cm
STANDARD_DEVIATION 9.35 • n=15 Participants • Thirty-nine subjects signed consent. Only thirty CRFs were returned to sponsor on closure of study. Remaining nine CRFs were assumed to be lost.
|
86.66 cm
STANDARD_DEVIATION 8.22 • n=15 Participants • Thirty-nine subjects signed consent. Only thirty CRFs were returned to sponsor on closure of study. Remaining nine CRFs were assumed to be lost.
|
90.74 cm
STANDARD_DEVIATION 9.49 • n=30 Participants • Thirty-nine subjects signed consent. Only thirty CRFs were returned to sponsor on closure of study. Remaining nine CRFs were assumed to be lost.
|
PRIMARY outcome
Timeframe: 1 month post treatment seriesPopulation: Of the thirty subjects who started the study, one of the treatment group and two from the control group were lost to follow-up.
Abdominal circumference measurement of the treated area at 1 month after the last treatment performed by controlled tape measurement
Outcome measures
| Measure |
Treatment Group
n=14 Participants
Group treated with the active Venus Versa octipolar applicator and the glycerin gel.
|
Control Group
n=13 Participants
Group treated with the inactive Venus Versa octipolar applicator and the glycerin gel.
|
|---|---|---|
|
Abdominal Circumference
|
90.18 cm
Standard Deviation 7.16
|
88.05 cm
Standard Deviation 8.78
|
SECONDARY outcome
Timeframe: 1 month post treatment seriesPopulation: Of the thirty subjects who started the study, one of the treatment group and two from the control group were lost to follow-up.
Subject 5-point Likert Satisfaction Assessment Scale where 4 = Very satisfied; 3 = Satisfied; 2 = Having no opinion; 1 = Unsatisfied and 0 = Very unsatisfied.
Outcome measures
| Measure |
Treatment Group
n=14 Participants
Group treated with the active Venus Versa octipolar applicator and the glycerin gel.
|
Control Group
n=13 Participants
Group treated with the inactive Venus Versa octipolar applicator and the glycerin gel.
|
|---|---|---|
|
Subject Satisfaction With Treatment
Very satisfied
|
3 Participants
|
0 Participants
|
|
Subject Satisfaction With Treatment
Satisfied
|
8 Participants
|
1 Participants
|
|
Subject Satisfaction With Treatment
Having no opinion
|
2 Participants
|
5 Participants
|
|
Subject Satisfaction With Treatment
Unsatisfied
|
1 Participants
|
3 Participants
|
|
Subject Satisfaction With Treatment
Very unsatisfied
|
0 Participants
|
4 Participants
|
Adverse Events
Treatment Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place