Circumference ReductionNCT02956720
UltraShape Power in Combination With U-sculpt-n Transducer
A study testing UltraShape Power in people with Circumference Reduction, run by Syneron Candela at 1 site in Israel.
Trial summary
Prospective, open label, self - controlled, single arm, clinical study to assess the performance of the UltraShape Power using the U-Sculpt-N on outer thigh and/or flank for circumference reduction versus self-control. 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?
- UltraShape Power
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2017to Oct 2018
- 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
- Subject ≥18 and ≤60 years of age at the time of enrollment
- Fat thickness of at least 1.5 cm in the outer thigh and/or flank (measured by calibrated caliper)
- For women of child-bearing potential: negative urine pregnancy test
- General good health confirmed by medical history and skin examination of the treated area
- Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed.
Who cannot join
- History of un-balanced hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker/defibrillator
- Current hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease
- Having a permanent implant in the treated area, such as metal plates, or an injected chemical substance such as silicone
- Previous liposuction in the treatment areas within 12 months
- History of skin disease in the treatment area, known tendency to form keloids or poor wound healing
- Abnormal kidney, liver or coagulation functions, abnormal lipid profile or blood count within the last 3 months
- Childbirth within the last 12 months or women who are breastfeeding a child
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of UltraShape Power System in Conjunction With the U-Sculpt-N Transducer for Non-invasive Circumference Reduction
Prospective, open label, self - controlled, single arm, clinical study to assess the performance of the UltraShape Power using the U-Sculpt-N on outer thigh and/or flank for circumference reduction versus self-control.
- Conditions
- Circumference Reduction
- Being tested
- UltraShape Power
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltraShape PowerDevice
non-invasive body contouring procedure
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | Not described Receives: Device: UltraShape Power |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outer thigh circumference reduction
To evaluate circumference reduction of outer thigh post treatment with UltraShape Power device used with the U-Sculpt-N transducer versus control side.
Measured: up to 24 week
Treatment-related adverse events
The frequency and severity of all treatment-related adverse events during and after using the UltraShape Power device used with the U-Sculpt-N transducer.
Measured: up to 24 week
Secondary outcomes (1)
Subject satisfaction questionnaire
The assessment of subject satisfaction with treatment will be recorded during relevant visits (starting following the first treatment) using a 5-point Likert scale
Measured: up to 24 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2016 (estimated)
- Study startJan 2017
- Primary completionMay 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- prospective, single arm
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Syneron Candela
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Ronen Glesinger, Syneron Candela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02956720
- Sponsor's protocol ID
- DHF21321
- Status last verified
- Jul 2017
- First submitted
- 30 Oct 2016
- Last updated
- 1 Aug 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of UltraShape Power System in Conjunction With the U-Sculpt-N Transducer for Non-invasive Circumference Reduction
- ClinicalTrials.gov ID
- NCT02956720
- Acronym / sponsor ID
- DHF21321
- Conditions
- Circumference Reduction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Syneron CandelaIndustry (pharma, biotech, devices)
- Study start
- Jan 2017 (actual)
- Primary completion
- May 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 7 Nov 2016 (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.
Prospective, open label, self - controlled, single arm, clinical study to assess the performance of the UltraShape Power using the U-Sculpt-N on outer thigh and/or flank for circumference reduction versus self-control.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective, single arm
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Device: UltraShape Power |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subject ≥18 and ≤60 years of age at the time of enrollment
- Fat thickness of at least 1.5 cm in the outer thigh and/or flank (measured by calibrated caliper)
- For women of child-bearing potential: negative urine pregnancy test
- General good health confirmed by medical history and skin examination of the treated area
- Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed.
Key exclusion criteria (7 listed)
- History of un-balanced hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker/defibrillator
- Current hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease
- Having a permanent implant in the treated area, such as metal plates, or an injected chemical substance such as silicone
- Previous liposuction in the treatment areas within 12 months
- History of skin disease in the treatment area, known tendency to form keloids or poor wound healing
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 |
|---|---|---|
| UltraShape Powernon-invasive body contouring procedure | Device | single arm |
Primary outcome
Outer thigh circumference reduction
Time frame: up to 24 week
To evaluate circumference reduction of outer thigh post treatment with UltraShape Power device used with the U-Sculpt-N transducer versus control side.
Treatment-related adverse events
Time frame: up to 24 week
The frequency and severity of all treatment-related adverse events during and after using the UltraShape Power device used with the U-Sculpt-N transducer.
1 secondary outcome
Subject satisfaction questionnaire
Time frame: up to 24 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UltraShape Power in people with Circumference Reduction, run by Syneron Candela at 1 site in Israel.
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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 1 Aug 2017. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ketty Shkolnik, Ph.D. (+972-73-2442268, kettys@syneron-candela.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outer thigh circumference reduction (time frame: up to 24 week). The study lists 2 primary outcomes in all. 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 1 Aug 2017; AzTrials last refreshed its copy on 7 Nov 2026.