Abdominal FatNCT02143960
VelaShape III Device in Comparison to Cryolipolysis for Circumferential Reduction
A study testing VelaShape III and CoolSculpt in people with Abdominal Fat, run by Syneron Medical at 1 site in United States.
Trial summary
The purpose of this study is to compare the clinical performance of the VelaShape III device with CoolSculpt for reduction of the waist, love handles and flanks. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Abdominal Fat
- What is being tested?
- VelaShape III and CoolSculpt
- 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
- Sep 2013to Sep 2014
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Informed consent process completed and subject completed consent.
- Fitzpatrick Skin Type I to VI
- Having excess fat deposits bilaterally in the waist / love-handle / flank areas.
- BMI score is greater than 18.5 and less than 29.9 - normal to overweight, but not obese.
- Willing to follow the treatment and follow-up schedule and post-treatment care instructions.
- Willingness to refrain from a change in diet/ exercise/medication regimen for the entire course of the study.
- If female, not pregnant, lactating and must be either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment (i.e., oral contraceptives, contraceptive implant, barrier methods with spermicide or abstinence).
- Willing to have photographs and images taken of the treated areas to be used de-identified in evaluations, publications and presentations.
Who cannot join
- Subjects with history of excessive weight fluctuation or expect to gain/lose more than 5 pounds) during the study time frame.
- Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.
- Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
- Having a permanent implant in the treated area, such as metal plates or an injected chemical substance such as silicone.
- Known photosensitivity.
- Having received treatment with laser, RF or other devices in the treated areas within 6 months of treatment or during the study.
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- Having undergone any other surgery in the treated areas within 12 months of treatment or during the study, including liposuction.
- 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.
- Having a known anticoagulative or thromboembolic condition or taking anticoagulation medications one week prior to and during the treatment course (to allow inclusion, temporary cessation of use as per the subject's physician discretion).
- History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
- Suffering from hormonal imbalance which may affect weight as per the Investigator's discretion.
- History of significant lymphatic drainage problems or impaired circulation in the area to be treated.
- 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 (duration of resolution as per the Investigator's discretion) or during the treatment course.
- History of keloid scarring, abnormal wound healing and / or prone to bruising.
- History of epidermal or dermal disorders (particularly if involving collagen or microvascularity).
- Use of isotretinoin (Accutane®) within 6 months of treatment or during the study.
- Allergy to any component of the lotion (VelaSpray Ease) used in this study.
- Cryoglobulinemia, Paroxysmal cold hemoglobinuria, or any known sensitivity to cold such as cold urticaria or Raynaud's disease.
- Neuropathic disorders such as post-herpetic neuralgia or diabetic neuropathy, or impaired skin sensation in the area to be treated.
- Hernia in the area to be treated.
- Participation in a study of another device or drug within 9 month prior to enrollment or during this study, if the treated area was involved.
- 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
Coleman Center for Cosmetic Dermatologic Surgery
Metairie, Louisiana, 70006
About this study
Official title: Clinical Study to Evaluate the Performance of the VelaShape III Device in Comparison to Cryolipolysis for Reduction in Waist / Love Handles / Flanks.
The purpose of this study is to compare the clinical performance of the VelaShape III device with CoolSculpt for reduction of the waist, love handles and flanks.
Read the detailed description
VelaShape is a non-invasive (not breaking the skin) device for Body Reshaping and Cellulite Treatment. VelaShape combines controlled infrared (IR) light and conducted bipolar radiofrequency (RF) energies with mechanical manipulation.
The CoolSculpt System is a noninvasive device that reduces fat by freezing fat cells until they break apart.
- Conditions
- Abdominal Fat
- Being tested
- VelaShape III, CoolSculpt
- Keywords
- Syneron, Velashape, ELOS, Zeltiq, Cryolipolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VelaShape IIIDevice
Also called Vela
Subjects will receive one treatment to their entire waist / love-handle/ flanks area in a split-waist fashion, so that one side is treated with one device and the other side is treated with the other device. The treatment session will include: one side (right or left) treated with the VelaShape III device and the other side (left or right, respectively) with the CoolSculpt device. The subject will be randomized to one of 2 treatment groups, one will receive treatment to the left side with the VelaShape II and the right side will receive treatment with the CoolSculpt. The other group will receive treatment to right side with the VelaShape II and the left side will receive treatment with the CoolSculpt.
CoolSculptDevice
Also called Zeltiq
Noninvasive Cryolipolysis
| Study group | Role | What they receive |
|---|---|---|
| Velashape III device | Active comparator | Controlled infrared (IR) light and conducted bipolar radiofrequency (RF) energies with mechanical manipulation Receives: Device: VelaShape III |
| Noninvasive Cryolipolysis Device | Active comparator | A noninvasive device that reduces fat by freezing fat cells Receives: Device: CoolSculpt |
What is being measured
The primary outcome is the main question the study is designed to answer.
A blinded rating of the treatment area
Improvement scores of photographs for the treatment side with the VelaShape III device versus the side treated with CoolSculpt will be blindly evaluated by independent reviewer at baseline and at 3 month post treatment time-point.
Measured: 3 month post treatment
Secondary outcomes (1)
A blinded rating of the treatment area
Improvement scores of photographs for the treatment side with the VelaShape III device versus the side treated with CoolSculpt will be blindly evaluated by independent reviewer at baseline and at 1 week, 1 month and 6 months post treatment time-point.
Measured: 1 week, 1 month and 6 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2014 (estimated)
- Study startSep 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal FatStudies 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syneron Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shlomit Mann, Study director, Syneron Medical Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02143960
- Sponsor's protocol ID
- DC85471
- Status last verified
- Nov 2014
- First submitted
- 19 May 2014
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Performance of the VelaShape III Device in Comparison to Cryolipolysis for Reduction in Waist / Love Handles / Flanks.
- ClinicalTrials.gov ID
- NCT02143960
- Acronym / sponsor ID
- DC85471
- Conditions
- Abdominal Fat
- Keywords
- Syneron, Velashape, ELOS, Zeltiq, Cryolipolysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Syneron MedicalIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 21 May 2014 (estimated)
- 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 purpose of this study is to compare the clinical performance of the VelaShape III device with CoolSculpt for reduction of the waist, love handles and flanks.
Detailed description
VelaShape is a non-invasive (not breaking the skin) device for Body Reshaping and Cellulite Treatment. VelaShape combines controlled infrared (IR) light and conducted bipolar radiofrequency (RF) energies with mechanical manipulation.
The CoolSculpt System is a noninvasive device that reduces fat by freezing fat cells until they break apart.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Velashape III device | Active comparator | Device: VelaShape IIIControlled infrared (IR) light and conducted bipolar radiofrequency (RF) energies with mechanical manipulation |
| Noninvasive Cryolipolysis Device | Active comparator | Device: CoolSculptA noninvasive device that reduces fat by freezing fat cells |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Informed consent process completed and subject completed consent.
- Fitzpatrick Skin Type I to VI
- Having excess fat deposits bilaterally in the waist / love-handle / flank areas.
- BMI score is greater than 18.5 and less than 29.9 - normal to overweight, but not obese.
- Willing to follow the treatment and follow-up schedule and post-treatment care instructions.
Key exclusion criteria (23 listed)
- Subjects with history of excessive weight fluctuation or expect to gain/lose more than 5 pounds) during the study time frame.
- Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.
- Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
- Having a permanent implant in the treated area, such as metal plates or an injected chemical substance such as silicone.
- Known photosensitivity.
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 |
|---|---|---|
| VelaShape IIIAlso: VelaSubjects will receive one treatment to their entire waist / love-handle/ flanks area in a split-waist fashion, so that one side is treated with one device and the other side is treated with the other device. The treatment session will include: one side (right or left) treated with the VelaShape III device and the other side (left or right, respectively) with the CoolSculpt device. The subject will be randomized to one of 2 treatment groups, one will receive treatment to the left side with the VelaShape II and the right side will receive treatment with the CoolSculpt. The other group will receive treatment to right side with the VelaShape II and the left side will receive treatment with the CoolSculpt. | Device | Velashape III device |
| CoolSculptAlso: ZeltiqNoninvasive Cryolipolysis | Device | Noninvasive Cryolipolysis Device |
Primary outcome
A blinded rating of the treatment area
Time frame: 3 month post treatment
Improvement scores of photographs for the treatment side with the VelaShape III device versus the side treated with CoolSculpt will be blindly evaluated by independent reviewer at baseline and at 3 month post treatment time-point.
1 secondary outcome
A blinded rating of the treatment area
Time frame: 1 week, 1 month and 6 months post 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 2 Dec 2014.
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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.
Shlomit Mann study director
Syneron Medical Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VelaShape III and CoolSculpt in people with Abdominal Fat, run by Syneron Medical 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 8 inclusion and 23 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 2 Dec 2014. 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?
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?
A blinded rating of the treatment area (time frame: 3 month post 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 2 Dec 2014.