LipodystrophyNCT02492997
Clinical Evaluation of Venus Versa Octipolar Applicator for Reduction of Abdomen Circumference
A study testing Venus Versa and Glycerine gel in people with Lipodystrophy, run by Venus Concept at 1 site in United States.
Trial summary
The octipolar applicator is intended for circumference reduction treatment by reduction of adipose size and enhancement of collagen synthesis as the result thermal and non-thermal collagen stimulation. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Lipodystrophy
- What is being tested?
- Venus Versa and Glycerine gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2015to 31 Oct 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) score is greater than 18.5 and less than 29.9 - normal to overweight, but not obese.
- Willingness to refrain from a change in diet/drinking/exercise/medication regimen for the entire course of the study.
- For female of child bearing potential - using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study (i.e., oral contraceptives, Intra Uterine Device (IUD), contraceptive implant, barrier methods with spermicide, or abstinence).
Who cannot join
- Pregnant or planning to become pregnant, having given birth less than 9 months ago, and/or breastfeeding.
- Having any active electrical implant anywhere in the body,
- Having a permanent implant in the treated areas
- Having received treatment with laser, RF or other devices in the treated areas within 6 months of treatment or during the study.
- Having undergone a liposuction surgery or any contouring treatment in the areas intended for treatment within 2 years of treatment
- Having or undergoing any form of cancer
Show all 18Show fewer
- Suffering from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), lupus, porphyria, or pertinent neurological disorders.
- Having a anticoagulative or thromboembolic condition or taking anticoagulation medications
- History of immunosuppression/immune deficiency disorders
- Suffering from hormonal imbalance which may affect weight or cellulite
- History of significant lymphatic drainage problems.
- History of keloid scarring or of abnormal wound healing.
- History of being especially prone to bruising.
- History of epidermal or dermal disorders
- Use of isotretinoin within 6 months
- Significant change in diet or exercise regimen within a month of enrollment or during this study and/or weight loss or gain of 10 lbs (4.5 kgs) within 2 months of enrollment or during this study.
- Participation in a study of another device or drug within 1 month prior to enrollment or during this study.
- As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
J Dermatology and Allergy
Fort Lee, New Jersey, 07024
About this study
The octipolar applicator is intended for circumference reduction treatment by reduction of adipose size and enhancement of collagen synthesis as the result thermal and non-thermal collagen stimulation. This trial is intended to evaluate the effect of radio frequency (RF) and pulsed electromagnetic fields (PEMF) treatment on circumference reduction.
Read the detailed description
This is a multi-site, prospective, controlled, randomized, double blinded clinical trial. This study is designed to evaluate the safety and efficacy of a series of treatments using the Venus Versa Octipolar applicator. Up to 60 healthy subjects at 10 sites shall be recruited by the investigator from within the investigator's subject population. Subjects shall have abdomen circumference to reduce for the designated treatment area.
Each subject will undergo 6 treatments at an interval of one treatment per week for six consecutive weeks. There will be a one month follow up which will occur 4 weeks after the 6th treatment.
At the first treatment visit, the investigator will collect demographic and medical information and randomization will take place. Subjects have an equal opportunity to be selected for the treatment or the control group.
The duration of the treatment session will be approximately 60 minutes. Expected immediate response includes temporary mild to moderate erythema and/or edema. Skin safety assessments will be conducted by the investigator after each treatment session and at the follow-up visit.
Photography will be conducted at baseline, the beginning of 4th \& 6th treatment and at 1 month follow up visit. Subjects will be asked to complete a questionnaire after each treatment and at the one month follow up visit.
Circumference measurements will be conducted at base line, before each treatment and at follow up visit. The treatment will be considered successful if the treated area circumference, reduces by at least 2.5 cm.
- Conditions
- Lipodystrophy
- Being tested
- Venus Versa, Glycerine gel
- Keywords
- body fat
- Medical subject headings
- Lipodystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venus VersaDevice
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 gelOther
Gel used to protect the skin from the RF energy and to assist with energy distribution
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Group treated with the active Venus Versa octipolar applicator and the glycerine gel. Receives: Device: Venus Versa; Other: Glycerine gel |
| Control Group | Sham comparator | Group treated with the inactive Venus Versa octipolar applicator and the glycerine gel. Receives: Device: Venus Versa; Other: Glycerine gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal Circumference
Abdominal circumference measurement of the treated area at 1 month after the last treatment performed by controlled tape measurement
Measured: 1 month post treatment series
Secondary outcomes (1)
Subject Satisfaction With Treatment
Subject 5-point Likert Satisfaction Assessment Scale where 4 = Very satisfied; 3 = Satisfied; 2 = Having no opinion; 1 = Unsatisfied and 0 = Very unsatisfied.
Measured: 1 month post treatment series
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2015 (estimated)
- Study start14 May 2015
- Primary completion25 Oct 2016
- Study completion31 Oct 2016
Why it stopped: Trial was terminated early due to slow enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LipodystrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Venus Concept
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tracey L Mancuso, Study director, Venus Concept
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02492997
- Sponsor's protocol ID
- CS0615
- Status last verified
- Nov 2020
- First submitted
- 19 Jun 2015
- Last updated
- 17 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Venus Versa Octipolar Applicator for Reduction of Abdomen Circumference
- ClinicalTrials.gov ID
- NCT02492997
- Acronym / sponsor ID
- CS0615
- Conditions
- Lipodystrophy
- Keywords
- body fat
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Trial was terminated early due to slow enrollment.
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Venus ConceptIndustry (pharma, biotech, devices)
- Study start
- 14 May 2015 (actual)
- Primary completion
- 25 Oct 2016 (actual)
- Study completion
- 31 Oct 2016 (actual)
- First posted
- 9 Jul 2015 (estimated)
- Results
- Posted 17 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The octipolar applicator is intended for circumference reduction treatment by reduction of adipose size and enhancement of collagen synthesis as the result thermal and non-thermal collagen stimulation. This trial is intended to evaluate the effect of radio frequency (RF) and pulsed electromagnetic fields (PEMF) treatment on circumference reduction.
Detailed description
This is a multi-site, prospective, controlled, randomized, double blinded clinical trial. This study is designed to evaluate the safety and efficacy of a series of treatments using the Venus Versa Octipolar applicator. Up to 60 healthy subjects at 10 sites shall be recruited by the investigator from within the investigator's subject population. Subjects shall have abdomen circumference to reduce for the designated treatment area.
Each subject will undergo 6 treatments at an interval of one treatment per week for six consecutive weeks. There will be a one month follow up which will occur 4 weeks after the 6th treatment.
At the first treatment visit, the investigator will collect demographic and medical information and randomization will take place. Subjects have an equal opportunity to be selected for the treatment or the control group.
The duration of the treatment session will be approximately 60 minutes. Expected immediate response includes temporary mild to moderate erythema and/or edema. Skin safety assessments will be conducted by the investigator after each treatment session and at the follow-up visit.
Photography will be conducted at baseline, the beginning of 4th \& 6th treatment and at 1 month follow up visit. Subjects will be asked to complete a questionnaire after each treatment and at the one month follow up visit.
Circumference measurements will be conducted at base line, before each treatment and at follow up visit. The treatment will be considered successful if the treated area circumference, reduces by at least 2.5 cm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: Venus Versa, Other: Glycerine gelGroup treated with the active Venus Versa octipolar applicator and the glycerine gel. |
| Control Group | Sham comparator | Device: Venus Versa, Other: Glycerine gelGroup treated with the inactive Venus Versa octipolar applicator and the glycerine gel. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body mass index (BMI) score is greater than 18.5 and less than 29.9 - normal to overweight, but not obese.
- Willingness to refrain from a change in diet/drinking/exercise/medication regimen for the entire course of the study.
- For female of child bearing potential - using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study (i.e., oral contraceptives, Intra Uterine Device (IUD), contraceptive implant, barrier methods with spermicide, or abstinence).
Key exclusion criteria (18 listed)
- Pregnant or planning to become pregnant, having given birth less than 9 months ago, and/or breastfeeding.
- Having any active electrical implant anywhere in the body,
- Having a permanent implant in the treated areas
- Having received treatment with laser, RF or other devices in the treated areas within 6 months of treatment or during the study.
- Having undergone a liposuction surgery or any contouring treatment in the areas intended for treatment within 2 years of treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Venus VersaThe 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. | Device | Control Group, Treatment Group |
| Glycerine gelGel used to protect the skin from the RF energy and to assist with energy distribution | Other | Control Group, Treatment Group |
Primary outcome
Abdominal Circumference
Time frame: 1 month post treatment series
Abdominal circumference measurement of the treated area at 1 month after the last treatment performed by controlled tape measurement
1 secondary outcome
Subject Satisfaction With Treatment
Time frame: 1 month post treatment series
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tracey L Mancuso study director
Venus Concept
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Venus Versa and Glycerine gel in people with Lipodystrophy, run by Venus Concept at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abdominal Circumference (time frame: 1 month post treatment series). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2020.