Circumference ReductionNCT03430245
VelaShape III & UltraShape Power for Thigh Circumference Reduction
A study testing VelaShape III and UltraShape Power in people with Circumference Reduction, run by Syneron Medical at 1 site in United States.
Trial summary
Prospective, one-arm, baseline-controlled pilot study for the evaluation of the VelaShape III combined with UltraShape Power treatment for non-invasive circumference reduction to the thighs. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Circumference Reduction
- What is being tested?
- VelaShape III and UltraShape Power
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2018to 3 Jul 2019
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed informed consent to participate in the study.
- Female and male subjects, 18 and 60 years of age at the time of enrollment.
- Fitzpatrick Skin Type I to VI.
- Fat thickness of at least 1.5 cm (measured by calibrated caliper).
- BMI interval: 22 ≤ BMI ≤ 30 (normal to overweight, but not obese).
- Female subjects 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).
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- In addition, negative urine pregnancy test as tested before each treatment and at the last visit for women with child-bearing potential (e.g. not menopausal).
- General good health confirmed by medical history and skin examination of the treated area.
- 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.
- Willing to have photographs and images taken of the treated areas to be used de-identified in evaluations, publications and presentations.
Who cannot join
- History of hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker/defibrillator, abdominal aortic aneurism.
- Known hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease.
- 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.
- 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.
- Having undergone any other surgery in the treated areas within 12 months of treatment or during the study, including liposuction.
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- Previous body contouring procedures in the treatment area within 12 months.
- History of skin disease in the treatment area, known tendency to form keloids or poor wound healing.
- Known photosensitivity.
- 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.
- Skin lesions in the treatment area other than simple nevi on physical examination (e.g., atypical nevus, tattoo, abrasions) including depressed scars in the treatment area.
- Very poor skin quality (i.e., severe laxity).
- Abdominal wall diastasis or hernia on physical examination.
- Abnormal kidney, liver or coagulation functions, abnormal lipid profile or blood count within the last 3 months.
- Obesity (BMI > 30).
- Pregnant, childbirth within the last 12 months or breastfeeding women.
- Any acute or chronic condition which, in the opinion of the investigator, could interfere with the conduct of the study.
- Unstable weight within the last 6 months (i.e., ± 3% weight change in the prior six months).
- Inability to comply with circumference measurement procedure (e.g., inability to hold breath for the required duration).
- Abdominal fat thickness lower than 2.5 cm after strapping.
- Participation in another clinical study within the last 6 months.
- 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
Skin Laser & Surgery Specialist of NY/NJ
Hackensack, New Jersey, 07601
About this study
Official title: Pilot Study to Evaluate VelaShape III & UltraShape Power Combined Treatment for Thigh Circumference Reduction
Prospective, one-arm, baseline-controlled pilot study for the evaluation of the VelaShape III combined with UltraShape Power treatment for non-invasive circumference reduction to the thighs.
Read the detailed description
Eligible subjects will receive 3 bi-weekly treatments to the thighs at 2-week intervals, with the VelaShape III and UltraShape Power devices according to the study protocol.
Each subject will return for 3 follow up visits: four weeks (4wk FU), 8 weeks (8wk FU) and 12 weeks (12wk FU) after the last treatment (Tx.3), for total expected study duration of 16 weeks.
- Conditions
- Circumference Reduction
- Being tested
- VelaShape III, UltraShape Power
- Keywords
- Circumference reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VelaShape IIIDevice
The VelaShape III device combines controlled infrared (IR) light and conducted bipolar radiofrequency (RF) energies with vacuum.
UltraShape PowerDevice
The UltraShape Power device uses focused ultrasound energy for lipolysis (breakdown of fat) via a non-thermal mechanism of action.
| Study group | Role | What they receive |
|---|---|---|
| VelaShape III & UltraShape Power | Experimental | VelaShape III treatment with radiofrequency, infrared and massage combined with UltraShape Power treatment, using pulsed, focused ultrasound treatment. Receives: Device: VelaShape III; Device: UltraShape Power |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circumference Change in the Thighs at the 12-week Follow-up Compared to Baseline Measurements
Circumference change of thigh midline post combined VelaShape III and UltraShape Power treatments. Negative change represent reduction in thigh circumference.
Measured: At 12 weeks after the third treatment (week 16) for each subject
Secondary outcomes (3)
Change in the Thighs Circumference at Each Treatment Visit Post Baseline and at The 4 and 8 Week Follow-up Visits
The thighs circumference change (at midline) after combined treatment with VelaShape III and UltraShape Power treatments compared to baseline.
The changed of thighs circumference was calculated at 2, 4, 8 and 12 weeks after baseline (which are second treatment , third treatment, 4 and 8 week follow-up visits, respectively).
Negative change represent reduction in thigh circumference.
Measured: At 2, 4, 8 and 12 weeks after baseline
Investigator Satisfaction
Investigator satisfaction assessment performed independently, using a 5- point Likert scale questionnaire from 2=very satisfied to -2=very unsatisfied at each follow-up visits (4, 8 and 12 weeks after the last treatment)
Measured: At 4, 8 and 12 weeks follow-up visits
Subject Satisfaction
Subject satisfaction assessment performed independently, using a 5- point Likert scale questionnaire from 2=very satisfied to -2=very unsatisfied at each follow-up visits (at 4, 8 and 12 weeks after the last treatment visit).
Measured: At 4, 8 and 12 week follow-up visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start19 Feb 2018
- Primary completion30 May 2019
- Study completion3 Jul 2019
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Circumference ReductionStudies 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
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syneron Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03430245
- Sponsor's protocol ID
- DHF24451
- Status last verified
- Dec 2019
- First submitted
- 24 Jan 2018
- Last updated
- 9 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Coleman WP 3rd, Coleman W 4th, Weiss RA, Kenkel JM, Ad-El DD, Amir R. A Multicenter Controlled Study to Evaluate Multiple Treatments With Nonthermal Focused Ultrasound for Noninvasive Fat Reduction. Dermatol Surg. 2017 Jan;43(1):50-57. doi: 10.1097/DSS.0000000000000918.
PubMed 28009680
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate VelaShape III & UltraShape Power Combined Treatment for Thigh Circumference Reduction
- ClinicalTrials.gov ID
- NCT03430245
- Acronym / sponsor ID
- DHF24451
- Conditions
- Circumference Reduction
- Keywords
- Circumference reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Syneron MedicalIndustry (pharma, biotech, devices)
- Study start
- 19 Feb 2018 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 3 Jul 2019 (actual)
- First posted
- 12 Feb 2018 (actual)
- Results
- Posted 26 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, one-arm, baseline-controlled pilot study for the evaluation of the VelaShape III combined with UltraShape Power treatment for non-invasive circumference reduction to the thighs.
Detailed description
Eligible subjects will receive 3 bi-weekly treatments to the thighs at 2-week intervals, with the VelaShape III and UltraShape Power devices according to the study protocol.
Each subject will return for 3 follow up visits: four weeks (4wk FU), 8 weeks (8wk FU) and 12 weeks (12wk FU) after the last treatment (Tx.3), for total expected study duration of 16 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VelaShape III & UltraShape Power | Experimental | Device: VelaShape III, Device: UltraShape PowerVelaShape III treatment with radiofrequency, infrared and massage combined with UltraShape Power treatment, using pulsed, focused ultrasound treatment. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Signed informed consent to participate in the study.
- Female and male subjects, 18 and 60 years of age at the time of enrollment.
- Fitzpatrick Skin Type I to VI.
- Fat thickness of at least 1.5 cm (measured by calibrated caliper).
- BMI interval: 22 ≤ BMI ≤ 30 (normal to overweight, but not obese).
Key exclusion criteria (22 listed)
- History of hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker/defibrillator, abdominal aortic aneurism.
- Known hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease.
- 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.
- 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.
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 IIIThe VelaShape III device combines controlled infrared (IR) light and conducted bipolar radiofrequency (RF) energies with vacuum. | Device | VelaShape III & UltraShape Power |
| UltraShape PowerThe UltraShape Power device uses focused ultrasound energy for lipolysis (breakdown of fat) via a non-thermal mechanism of action. | Device | VelaShape III & UltraShape Power |
Primary outcome
Circumference Change in the Thighs at the 12-week Follow-up Compared to Baseline Measurements
Time frame: At 12 weeks after the third treatment (week 16) for each subject
Circumference change of thigh midline post combined VelaShape III and UltraShape Power treatments. Negative change represent reduction in thigh circumference.
3 secondary outcomes
Change in the Thighs Circumference at Each Treatment Visit Post Baseline and at The 4 and 8 Week Follow-up Visits
Time frame: At 2, 4, 8 and 12 weeks after baseline
Investigator Satisfaction
Time frame: At 4, 8 and 12 weeks follow-up visits
Subject Satisfaction
Time frame: At 4, 8 and 12 week follow-up visits
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28009680Coleman WP 3rd, Coleman W 4th, Weiss RA, Kenkel JM, Ad-El DD, Amir R. A Multicenter Controlled Study to Evaluate Multiple Treatments With Nonthermal Focused Ultrasound for Noninvasive Fat Reduction. Dermatol Surg. 2017 Jan;43(1):50-57. doi: 10.1097/DSS.0000000000000918.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 UltraShape Power in people with Circumference Reduction, 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 11 inclusion and 22 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 9 Jan 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. 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 26 Dec 2019). 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?
Circumference Change in the Thighs at the 12-week Follow-up Compared to Baseline Measurements (time frame: At 12 weeks after the third treatment (week 16) for each subject). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03430245, which also lists 1 linked publication.
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 9 Jan 2020.