LipolysisNCT03588702
RF and PEMF Following Liposuction
A study testing RF and PEMF treatment in people with Lipolysis, run by Venus Concept at 1 site in Spain.
Trial summary
The Venus Legacy LB2 Body applicator is intended for circumference reduction treatment by reducing fat cell size and enhancing collagen synthesis as the result of 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
- Lipolysis
- What is being tested?
- RF and PEMF treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 2 Jul 2018to 13 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy male or female older than 18 years of age but not older than 65 years of age.
- Having suitable area for treatment (bilateral liposuction of the back, flanks or thighs performed 8 weeks prior to study).
- BMI score is greater than 18.5 and less than 29.9.
- Willingness to refrain from a change in diet/drinking/exercise/medication regimen for the entire course of the study.
Who cannot join
- Pregnant or planning to become pregnant, having given birth (vaginal birth or Caesarean surgery) less than 9 months ago, and/or breastfeeding.
- Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
- Having a permanent implant in the treated areas, such as metal plates and screws or an injected chemical substance.
- Having undergone any other surgery in the treated areas within 9 months of treatment or during the study.
- Having or undergoing any form of treatment for active cancer, or having a history of skin cancer or any other cancer in the areas to be treated, including presence of malignant or pre-malignant pigmented lesions.
- Suffering from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), lupus, porphyria, or pertinent neurological disorders.
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- Having a known anti-coagulative or thromboembolic condition or taking anticoagulation medications one week prior to and during the treatment course.
- History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
- Suffering from hormonal imbalance which may affect weight or cellulite.
- History of significant lymphatic drainage problems.
- Suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including, but not limited to, open lacerations or abrasions and active cold sores or herpes sores prior to treatment or during the treatment course.
- History of keloid scarring or of abnormal wound healing.
- History of being especially prone to bruising.
- History of epidermal or dermal disorders (particularly if involving collagen or micro-vascularity).
- Use of oral retinoids (e.g. isotretinoin (Accutane®)) within 6 months of treatment or during the study.
- Use of anti-cellulite creams within a month of treatment or during the course of the study.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of the Safety and Performance of RF and PEMF Following Liposuction
The Venus Legacy LB2 Body applicator is intended for circumference reduction treatment by reducing fat cell size and enhancing collagen synthesis as the result of thermal and non-thermal collagen stimulation. This is an open-label, evaluator-blind study of the safety and performance of radiofrequency (RF) and pulsed electromagnetic field (PEMF) therapy following liposuction. The study will enroll up to 50 male and female subjects requesting treatment of the back, flanks and/or thighs to improve appearance following liposuction. Subjects will receive a total of six study treatments to one side of their body (back, flanks and/or thighs) at one week intervals. Subjects will be followed up at one month after their last study treatment. Treatment outcomes will be compared to the non-treated side.
Read the detailed description
Adipose tissue is a loose type of connective tissue specialized to store lipids. The majority of lipids stored in adipose cells are triglycerides formed from imported free fatty acids and glycerol. It is not uniformly distributed in the body. The major adipose depot is subcutaneous (about 80% of all body fat).
The technology options for skin tightening and body contouring have included vacuum massage, infrared laser energy, high frequency focused ultrasound, cryolipolysis, radiofrequency energy and various hybrid energy device options. Radiofrequency energy devices have remained the most common and dominant technology in the noninvasive management of skin tightening, cellulite improvement and body contouring enhancement, as they can treat all these conditions with relatively consistent results.
The RF energy is high frequency alternating electrical current that passes into the dermis and hypodermal tissues without disruption of the epidermal-dermal barrier. The high frequency oscillating electrical current results in collisions between charged molecules and ions and the micromolecular mechanical energy from these collisions is transformed into heat. This biological RF heat occurs irrespective of chromophore or skin type and is not dependent upon selective photothermolysis. The RF heat has different biological and hence, clinical effects, depending upon the tissue targeted. In the dermis, where the primary cellular element is the fibroblast and the extracellular matrix (ECM) is comprised of collagen, elastin and ground substances, the RF mediated thermal stimulation of the ECM results in an immediate and temporary shrinkage of the collagen triple helix. Further, the RF thermal stimulation results in a microinflammatory stimulation of the fibroblast which in response produces new collagen (neocollagenesis) and new elastin neoelastogenesis), and ground substances. RF thermal stimulation of adipose tissue results in a thermal mediated stimulation and augmented activity of lipase mediated enzymatic degradation of adipocyte derived triglycerides into free fatty acids and glycerol. This amplification of the physiologic breakdown and egress of the triglycerides out of the adipocyte, while keeping the adipocyte cell membrane and cell function intact, results in RF induced shrinkage of the fat cells and body contouring.
The Venus Legacy LB2 Body Applicator Combines Multi-Polar RF current and Pulsed Electromagnetic Fields (PEMF) in synergy with suction/vacuum. PEMF has been shown to increase fibroblast derived collagen production through a non-thermal mechanism of membrane stimulation, and the stimulation of fibroblast mediated angiogenesis which facilitates and enhances wound healing in tissues. Theoretically then, the synergistic RF and PEMF would create RF thermal collagen stimulation and PEMF non-thermal stimulation of collagen, RF thermally mediated reduction in adipocyte size and PEMF micro-tissue healing effects to minimize edema, swelling and downtime that are associated with pure RF thermal therapies.
The objective of this clinical study is to evaluate the safety and performance of RF and PEMF using the Venus Legacy LB2 body applicator following liposuction to the back, flanks and/or thighs.
- Conditions
- Lipolysis
- Being tested
- RF and PEMF treatment
- Keywords
- radiofrequency, pulsed electro-magnetic fields, liposuction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RF and PEMF treatmentDevice
Also called Venus Legacy LB2 Body applicator
Treatment with Venus Legacy LB2 body applicator
| Study group | Role | What they receive |
|---|---|---|
| Venus Legacy LB2 Body applicator group | Experimental | Liposuction area is divided into 2 equal sections. One section receives RF and PEMF treatment. Receives: Device: RF and PEMF treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in skin appearance of the treated side
Using the General Aesthetic improvement scale (GAIS), blinded reviewers assess photos of liposuction area to determine improvement in treated side as compared to non-treated side where 3 is very much improved; 2 is much improved; 1 is imporved; 0 is no change; -1 is worse; -2 is much worse and -3 is very much worse.
Measured: One month after last treatment
Secondary outcomes (2)
Improvement in skin elasticity of the treated side
As measured by a cutometer, determine improvement in skin elasticity of the treated side as compared to the non-treated side where parameter R2, gross elasticity is used. The closer the value is to 1 (100%), the more elastic the skin.
Measured: One month after last treatment
Subject satisfaction of treatment
Using the 5-point Likert Satisfaction scale, subjects indicate their satisfaction with the appearance of the treated side as compared to non-treated side where 0 is very unsatisfied; 1 is unsatisfied; 2 is having no opinion; 3 is satisfied and 4 is very satisfied.
Measured: One month after last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start2 Jul 2018
- Primary completion13 Nov 2020
- Study completion13 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LipolysisStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects act as their own control.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Venus Concept
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Cardarelli, Study director, Venus Concept
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03588702
- Sponsor's protocol ID
- CS0817
- Status last verified
- Apr 2023
- First submitted
- 3 Jul 2018
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Safety and Performance of RF and PEMF Following Liposuction
- ClinicalTrials.gov ID
- NCT03588702
- Acronym / sponsor ID
- CS0817
- Conditions
- Lipolysis
- Keywords
- radiofrequency, pulsed electro-magnetic fields, liposuction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Venus ConceptIndustry (pharma, biotech, devices)
- Study start
- 2 Jul 2018 (actual)
- Primary completion
- 13 Nov 2020 (actual)
- Study completion
- 13 Nov 2020 (actual)
- First posted
- 17 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Venus Legacy LB2 Body applicator is intended for circumference reduction treatment by reducing fat cell size and enhancing collagen synthesis as the result of thermal and non-thermal collagen stimulation. This is an open-label, evaluator-blind study of the safety and performance of radiofrequency (RF) and pulsed electromagnetic field (PEMF) therapy following liposuction. The study will enroll up to 50 male and female subjects requesting treatment of the back, flanks and/or thighs to improve appearance following liposuction. Subjects will receive a total of six study treatments to one side of their body (back, flanks and/or thighs) at one week intervals. Subjects will be followed up at one month after their last study treatment. Treatment outcomes will be compared to the non-treated side.
Detailed description
Adipose tissue is a loose type of connective tissue specialized to store lipids. The majority of lipids stored in adipose cells are triglycerides formed from imported free fatty acids and glycerol. It is not uniformly distributed in the body. The major adipose depot is subcutaneous (about 80% of all body fat).
The technology options for skin tightening and body contouring have included vacuum massage, infrared laser energy, high frequency focused ultrasound, cryolipolysis, radiofrequency energy and various hybrid energy device options. Radiofrequency energy devices have remained the most common and dominant technology in the noninvasive management of skin tightening, cellulite improvement and body contouring enhancement, as they can treat all these conditions with relatively consistent results.
The RF energy is high frequency alternating electrical current that passes into the dermis and hypodermal tissues without disruption of the epidermal-dermal barrier. The high frequency oscillating electrical current results in collisions between charged molecules and ions and the micromolecular mechanical energy from these collisions is transformed into heat. This biological RF heat occurs irrespective of chromophore or skin type and is not dependent upon selective photothermolysis. The RF heat has different biological and hence, clinical effects, depending upon the tissue targeted. In the dermis, where the primary cellular element is the fibroblast and the extracellular matrix (ECM) is comprised of collagen, elastin and ground substances, the RF mediated thermal stimulation of the ECM results in an immediate and temporary shrinkage of the collagen triple helix. Further, the RF thermal stimulation results in a microinflammatory stimulation of the fibroblast which in response produces new collagen (neocollagenesis) and new elastin neoelastogenesis), and ground substances. RF thermal stimulation of adipose tissue results in a thermal mediated stimulation and augmented activity of lipase mediated enzymatic degradation of adipocyte derived triglycerides into free fatty acids and glycerol. This amplification of the physiologic breakdown and egress of the triglycerides out of the adipocyte, while keeping the adipocyte cell membrane and cell function intact, results in RF induced shrinkage of the fat cells and body contouring.
The Venus Legacy LB2 Body Applicator Combines Multi-Polar RF current and Pulsed Electromagnetic Fields (PEMF) in synergy with suction/vacuum. PEMF has been shown to increase fibroblast derived collagen production through a non-thermal mechanism of membrane stimulation, and the stimulation of fibroblast mediated angiogenesis which facilitates and enhances wound healing in tissues. Theoretically then, the synergistic RF and PEMF would create RF thermal collagen stimulation and PEMF non-thermal stimulation of collagen, RF thermally mediated reduction in adipocyte size and PEMF micro-tissue healing effects to minimize edema, swelling and downtime that are associated with pure RF thermal therapies.
The objective of this clinical study is to evaluate the safety and performance of RF and PEMF using the Venus Legacy LB2 body applicator following liposuction to the back, flanks and/or thighs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects act as their own control.
| Arm | Type | Receives |
|---|---|---|
| Venus Legacy LB2 Body applicator group | Experimental | Device: RF and PEMF treatmentLiposuction area is divided into 2 equal sections. One section receives RF and PEMF treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy male or female older than 18 years of age but not older than 65 years of age.
- Having suitable area for treatment (bilateral liposuction of the back, flanks or thighs performed 8 weeks prior to study).
- BMI score is greater than 18.5 and less than 29.9.
- Willingness to refrain from a change in diet/drinking/exercise/medication regimen for the entire course of the study.
Key exclusion criteria (18 listed)
- Pregnant or planning to become pregnant, having given birth (vaginal birth or Caesarean surgery) less than 9 months ago, and/or breastfeeding.
- Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
- Having a permanent implant in the treated areas, such as metal plates and screws or an injected chemical substance.
- Having undergone any other surgery in the treated areas within 9 months of treatment or during the study.
- Having or undergoing any form of treatment for active cancer, or having a history of skin cancer or any other cancer in the areas to be treated, including presence of malignant or pre-malignant pigmented lesions.
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 |
|---|---|---|
| RF and PEMF treatmentAlso: Venus Legacy LB2 Body applicatorTreatment with Venus Legacy LB2 body applicator | Device | Venus Legacy LB2 Body applicator group |
Primary outcome
Improvement in skin appearance of the treated side
Time frame: One month after last treatment
Using the General Aesthetic improvement scale (GAIS), blinded reviewers assess photos of liposuction area to determine improvement in treated side as compared to non-treated side where 3 is very much improved; 2 is much improved; 1 is imporved; 0 is no change; -1 is worse; -2 is much worse and -3 is very much worse.
2 secondary outcomes
Improvement in skin elasticity of the treated side
Time frame: One month after last treatment
Subject satisfaction of treatment
Time frame: One month after last treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
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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.
Paul Cardarelli 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 RF and PEMF treatment in people with Lipolysis, run by Venus Concept at 1 site in Spain.
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 4 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: finished, as of the sponsor's last update on 26 Apr 2023. 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 Spain. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Improvement in skin appearance of the treated side (time frame: One month after last treatment). 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 26 Apr 2023.