Adipose TissueNCT02569112
Evaluation of CoolSculpt Combining Venus Legacy Technology for Enhanced Results in Fat Reduction & Laxity of the Flanks
A study testing multipolar RF, varipulse and cryolipolysis in people with Adipose Tissue, run by Venus Concept at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effect on the subject outcome using the combination of the Zeltiq Cryolipolysis device and the Venus Concept multipolar radiofrequency device with varipulse technology for the enhanced non-surgical treatment of skin laxity in the flank area. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Adipose Tissue
- What is being tested?
- multipolar RF, varipulse and cryolipolysis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to 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 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects who can read, understand, and sign the Informed Consent Form.
- Subjects willing and able to comply with all study requirements.
- Subjects who have pre-scheduled a body contouring procedure.
- Subjects have clearly visible fat on the flanks, which in the investigator's opinion, may benefit from the treatment.
- Subjects have not had weight change exceeding 10 pounds in the preceding month.
- Subjects agree to maintain his/her weight (i.e., within 5 pounds) by not making any major changes in their diet or lifestyle during the course of the study.
Who cannot join
- Subjects with active localized or systemic infections.
- Immuno-compromised subjects.
- Pregnant and/or lactating (All female volunteers will be advised about using birth control during the period of study).
- In the opinion of the trained clinician, subject is unwilling or unable to adhere to all study requirements, including application and follow-up visits.
- Subjects with a history of radiation therapy to the treatment area.
- Subjects with any skin pathology or condition that could interfere with evaluation or with the use of typical ancillary medical treatments or care used before, during or after treatments.
Show all 18Show fewer
- Subject has had a surgical procedure(s) in the area of intended treatment.
- Subject has had an invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the area of intended treatment.
- Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 12 months.
- Subject needs to administer, or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.
- Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
- Subject has a known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
- Subject has a history of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
- Subject is taking or has taken diet pills or supplements within the past month.
- Subject has any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites that may interfere with the treatment or evaluation (stretch marks is not an exclusion).
- Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system
- Subject has a history of hernia in the areas to be treated.
- Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Internally Controlled Blind Reviewed Clinical Evaluation of Cryolipolysis Combined With MP2 Technology for Enhanced Subject Results in Circumferential Fat Reduction and Skin Laxity of the Flanks
The purpose of this study is to evaluate the effect on the subject outcome using the combination of the Zeltiq Cryolipolysis device and the Venus Concept multipolar radiofrequency device with varipulse technology for the enhanced non-surgical treatment of skin laxity in the flank area.
Read the detailed description
Commercially available as the Zeltiq CoolSculpting system, cryolipolysis is FDA cleared for use in the United States for an indication of fat layer reduction in the flanks, thighs, and abdomen through cold-assisted lipolysis. CoolSculpting has been clinically proven to non-surgically reduce subcutaneous fat bulges, allowing patients to achieve noticeable and measurable aesthetic results without the pain, expense, downtime, and risks associated with existing invasive and minimally-invasive procedures. The Zeltiq CoolSculpting System is a non-invasive device designed to cool subcutaneous fat without affecting adjacent or underlying structures.
The RF device to be used in this study is a FDA cleared device used for aesthetic non-surgical skin tightening procedures including wrinkles, skin rhytides and cellulite in the face and body. The Venus Legacy utilizes a multi-polar radiofrequency system to deliver homogenous heating to multiple tissue depths. The Venus Legacy device also utilizes pulsed magnetic field technology as well as pulsed negative pressure technology.
The flanks of Ten (10) healthy adults (male and female), 21 to 50 years of age, who desire a reduction in focal fat of the flanks will be recruited from the investigator's subject populations. Informed Consent will be obtained from each subject during a screening visit.
The photos will be taken prior to the treatment series, one week post treatment series, at 3 and 6 months post treatment series for the evaluation of two blinded reviewers as well as for the investigator to assess.
- Conditions
- Adipose Tissue
- Being tested
- multipolar RF, varipulse, cryolipolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multipolar RF, varipulseDevice
Also called Venus Legacy
Multi-polar Radio frequency (RF) technology combining pulsed electro magnetic fields (PEMF) and mild suction stimulation (varipulse).
cryolipolysisDevice
Also called CoolSculpt
Cryolipolysis technology uses the sensitivity of fat cells to cold injury, causing them to freeze and undergo cellular apoptosis.
| Study group | Role | What they receive |
|---|---|---|
| cryolipolysis | Active comparator | Each patient is their own control and one side will have only a cryolipolysis treatment while the other side will have a cryolipolysis treatment plus multipolar radiofrequency and varipulse treatment. Receives: Device: cryolipolysis |
| cryolipolysis, multipolar RF, varipulse | Experimental | Each patient is their own control and one side will have only a cryolipolysis treatment while the other side will have a cryolipolysis treatment plus multipolar radiofrequency and varipulse treatment. Receives: Device: multipolar RF, varipulse; Device: cryolipolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
General Improvement in Skin Laxity of the Flank Area
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2015 (estimated)
- Study startAug 2015
- Primary completionJun 2016
- Study completionOct 2016
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 Adipose TissueStudies 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
- Non-randomised
- Intervention model
- Single group
- Model description
- All participants to receive cryolipolysis treatment on one side of their body and cryolipolysis plus multipolar radiofrequency with varipulse technology treatment on the other side of their body.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Venus Concept
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Julius Few, MD, Principal investigator, Few Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02569112
- Sponsor's protocol ID
- CS0915
- Status last verified
- Dec 2017
- First submitted
- 24 Aug 2015
- Last updated
- 18 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Internally Controlled Blind Reviewed Clinical Evaluation of Cryolipolysis Combined With MP2 Technology for Enhanced Subject Results in Circumferential Fat Reduction and Skin Laxity of the Flanks
- ClinicalTrials.gov ID
- NCT02569112
- Acronym / sponsor ID
- CS0915
- Conditions
- Adipose Tissue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Venus ConceptIndustry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 6 Oct 2015 (estimated)
- Results
- Posted 18 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effect on the subject outcome using the combination of the Zeltiq Cryolipolysis device and the Venus Concept multipolar radiofrequency device with varipulse technology for the enhanced non-surgical treatment of skin laxity in the flank area.
Detailed description
Commercially available as the Zeltiq CoolSculpting system, cryolipolysis is FDA cleared for use in the United States for an indication of fat layer reduction in the flanks, thighs, and abdomen through cold-assisted lipolysis. CoolSculpting has been clinically proven to non-surgically reduce subcutaneous fat bulges, allowing patients to achieve noticeable and measurable aesthetic results without the pain, expense, downtime, and risks associated with existing invasive and minimally-invasive procedures. The Zeltiq CoolSculpting System is a non-invasive device designed to cool subcutaneous fat without affecting adjacent or underlying structures.
The RF device to be used in this study is a FDA cleared device used for aesthetic non-surgical skin tightening procedures including wrinkles, skin rhytides and cellulite in the face and body. The Venus Legacy utilizes a multi-polar radiofrequency system to deliver homogenous heating to multiple tissue depths. The Venus Legacy device also utilizes pulsed magnetic field technology as well as pulsed negative pressure technology.
The flanks of Ten (10) healthy adults (male and female), 21 to 50 years of age, who desire a reduction in focal fat of the flanks will be recruited from the investigator's subject populations. Informed Consent will be obtained from each subject during a screening visit.
The photos will be taken prior to the treatment series, one week post treatment series, at 3 and 6 months post treatment series for the evaluation of two blinded reviewers as well as for the investigator to assess.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- All participants to receive cryolipolysis treatment on one side of their body and cryolipolysis plus multipolar radiofrequency with varipulse technology treatment on the other side of their body.
| Arm | Type | Receives |
|---|---|---|
| cryolipolysis | Active comparator | Device: cryolipolysisEach patient is their own control and one side will have only a cryolipolysis treatment while the other side will have a cryolipolysis treatment plus multipolar radiofrequency and varipulse treatment. |
| cryolipolysis, multipolar RF, varipulse | Experimental | Device: multipolar RF, varipulse, Device: cryolipolysisEach patient is their own control and one side will have only a cryolipolysis treatment while the other side will have a cryolipolysis treatment plus multipolar radiofrequency and varipulse treatment. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subjects who can read, understand, and sign the Informed Consent Form.
- Subjects willing and able to comply with all study requirements.
- Subjects who have pre-scheduled a body contouring procedure.
- Subjects have clearly visible fat on the flanks, which in the investigator's opinion, may benefit from the treatment.
- Subjects have not had weight change exceeding 10 pounds in the preceding month.
Key exclusion criteria (18 listed)
- Subjects with active localized or systemic infections.
- Immuno-compromised subjects.
- Pregnant and/or lactating (All female volunteers will be advised about using birth control during the period of study).
- In the opinion of the trained clinician, subject is unwilling or unable to adhere to all study requirements, including application and follow-up visits.
- Subjects with a history of radiation therapy to the treatment area.
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 |
|---|---|---|
| multipolar RF, varipulseAlso: Venus LegacyMulti-polar Radio frequency (RF) technology combining pulsed electro magnetic fields (PEMF) and mild suction stimulation (varipulse). | Device | cryolipolysis, multipolar RF, varipulse |
| cryolipolysisAlso: CoolSculptCryolipolysis technology uses the sensitivity of fat cells to cold injury, causing them to freeze and undergo cellular apoptosis. | Device | cryolipolysis, cryolipolysis, multipolar RF, varipulse |
Primary outcome
General Improvement in Skin Laxity of the Flank Area
Time frame: 6 months
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2018.
- 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.
Julius Few, MD principal investigator
Few Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multipolar RF, varipulse and cryolipolysis in people with Adipose Tissue, 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 6 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 18 Jun 2018. 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. 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 18 Jun 2018). 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?
General Improvement in Skin Laxity of the Flank Area (time frame: 6 months). 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 18 Jun 2018.