Abdominal FatNCT02154113
Ultrashape System in Combination With VelaShape II Device for Circumferential Reduction
A study testing Ultrashape and Velashape II in people with Abdominal Fat, run by Syneron Medical at 2 sites in Canada.
Trial summary
The purpose of this study is to compare the clinical performance of the Ultrashape system with VelaShape II device for reduction of the waist. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Abdominal Fat
- What is being tested?
- Ultrashape and Velashape II
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesCanada
- Study dates
- Oct 2012to Sep 2013
- 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
- Fat thickness of at least 1.5 cm in the anterior abdominal and flanks prior to initial treatment (measurement by caliper)
- For women of child-bearing potential: negative pregnancy test in the 24 hour period prior to enrollment and 24 hour period prior to each treatment or FU visit (measured in urine)
- General good health confirmed by medical history and skin examination of the treated area
- Written informed consent to participate in the study
- Ability to comply with the requirements of the study
- BMI≤ 30
Who cannot join
- History of hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker/defibrillator, abdominal aortic aneurism
- Current hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease or malignancy
- Previous liposuction in the treatment areas
- History of skin disease in the treatment area, known tendency to form keloids or poor wound healing
- 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
- Poor skin quality (i.e., laxity)
Show all 15Show fewer
- 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)
- Childbirth within the last 12 months or women who suckling a child
- 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 held breath for the required duration)
- Participation in another clinical study
- Previous body contouring treatments in the treatment areas
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Cosmedica
Pointe-Claire, Quebec, H9R 5N3
BC Laser & SkinCare Clinic
Surrey, British Columbia, V3T 1W7
About this study
Official title: Baseline Controlled Two-arm Multi-Center Study to Evaluate the Safety and Efficacy of Combined Multi-Focus Treatments of UltraShape® Contour I V3 System and VelaShape II Device for Non-Invasive Circumference Reduction
The purpose of this study is to compare the clinical performance of the Ultrashape system with VelaShape II device for reduction of the waist.
Read the detailed description
UltraShape® Contour I V3 system is a non-invasive (not breaking the skin) focused ultrasound for body contouring purposesdesigned to selectively disrupt sub-dermal fat cells employing focused ultrasound. All other types of tissue, such as blood vessels, muscles and peripheral nerves, remain intact. There are no thermal effects. Fat-cell destruction is achieved by ultrasound-induced mechanical effects during a very short exposure time.
VelaShape is a non-invasive device for Body Reshaping and Cellulite Treatment. VelaShape combines controlled infrared (IR) light and conducted bipolar radiofrequency (RF) energies with mechanical manipulation.
- Conditions
- Abdominal Fat
- Being tested
- Ultrashape, Velashape II
- Keywords
- Syneron, Velashape, ELOS, Ultrashape
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrashapeDevice
All subjects receive 3 successive Ultrashape treatments every two weeks in the anterior abdomen.
Velashape IIDevice
Also called Vela, Velashape
All subjects receive 3 successive Velashape treatments every two weeks in the anterior abdomen.
| Study group | Role | What they receive |
|---|---|---|
| Velashape II device | Active comparator | Controlled infrared (IR) light and conducted bipolar radiofrequency (RF) energies with mechanical manipulation. Receives: Device: Velashape II |
| Ultrashape | Active comparator | The UltraShape Contour I V3 uses focused ultrasound to produce localized mechanical motion within fat tissues and cells for the purpose of producing mechanical cellular membrane disruption. Receives: Device: Ultrashape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in circumference reduction between baseline and follow-up visits
The primary efficacy endpoint in this trial is the statistical difference in circumference reduction between Control (baseline measurement, Vist 2 / Day 0) and two points of follow-up measurement: 2 weeks (Visit 5 / Day 42) and 12 weeks (Visit 8 / Day 112) following the last Tx session. The following procedure will be used to compute the Circumference Difference primary endpoint:
Measured: Base line, 2 and 12 weeks post last treatment
Secondary outcomes (1)
Adverse Events
Safety will be evaluated based on the incidence and severity of adverse events caused by the treatments
Measured: The duration of the study, an expected average of 5 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study startOct 2012
- Primary completionAug 2013
- Study completionSep 2013
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 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
- NCT02154113
- Sponsor's protocol ID
- US-CA 02
- Status last verified
- May 2014
- First submitted
- 27 May 2014
- Last updated
- 3 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baseline Controlled Two-arm Multi-Center Study to Evaluate the Safety and Efficacy of Combined Multi-Focus Treatments of UltraShape® Contour I V3 System and VelaShape II Device for Non-Invasive Circumference Reduction
- ClinicalTrials.gov ID
- NCT02154113
- Acronym / sponsor ID
- US-CA 02
- Conditions
- Abdominal Fat
- Keywords
- Syneron, Velashape, ELOS, Ultrashape
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Syneron MedicalIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 3 Jun 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 Ultrashape system with VelaShape II device for reduction of the waist.
Detailed description
UltraShape® Contour I V3 system is a non-invasive (not breaking the skin) focused ultrasound for body contouring purposesdesigned to selectively disrupt sub-dermal fat cells employing focused ultrasound. All other types of tissue, such as blood vessels, muscles and peripheral nerves, remain intact. There are no thermal effects. Fat-cell destruction is achieved by ultrasound-induced mechanical effects during a very short exposure time.
VelaShape is a non-invasive device for Body Reshaping and Cellulite Treatment. VelaShape combines controlled infrared (IR) light and conducted bipolar radiofrequency (RF) energies with mechanical manipulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Velashape II device | Active comparator | Device: Velashape IIControlled infrared (IR) light and conducted bipolar radiofrequency (RF) energies with mechanical manipulation. |
| Ultrashape | Active comparator | Device: UltrashapeThe UltraShape Contour I V3 uses focused ultrasound to produce localized mechanical motion within fat tissues and cells for the purpose of producing mechanical cellular membrane disruption. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Fat thickness of at least 1.5 cm in the anterior abdominal and flanks prior to initial treatment (measurement by caliper)
- For women of child-bearing potential: negative pregnancy test in the 24 hour period prior to enrollment and 24 hour period prior to each treatment or FU visit (measured in urine)
- General good health confirmed by medical history and skin examination of the treated area
- Written informed consent to participate in the study
- Ability to comply with the requirements of the study
Key exclusion criteria (15 listed)
- History of hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker/defibrillator, abdominal aortic aneurism
- Current hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease or malignancy
- Previous liposuction in the treatment areas
- History of skin disease in the treatment area, known tendency to form keloids or poor wound healing
- 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
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 |
|---|---|---|
| UltrashapeAll subjects receive 3 successive Ultrashape treatments every two weeks in the anterior abdomen. | Device | Ultrashape |
| Velashape IIAlso: Vela, VelashapeAll subjects receive 3 successive Velashape treatments every two weeks in the anterior abdomen. | Device | Velashape II device |
Primary outcome
Difference in circumference reduction between baseline and follow-up visits
Time frame: Base line, 2 and 12 weeks post last treatment
The primary efficacy endpoint in this trial is the statistical difference in circumference reduction between Control (baseline measurement, Vist 2 / Day 0) and two points of follow-up measurement: 2 weeks (Visit 5 / Day 42) and 12 weeks (Visit 8 / Day 112) following the last Tx session. The following procedure will be used to compute the Circumference Difference primary endpoint:
1 secondary outcome
Adverse Events
Time frame: The duration of the study, an expected average of 5 months.
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 3 Jun 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrashape and Velashape II in people with Abdominal Fat, run by Syneron Medical at 2 sites in Canada.
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 15 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 3 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
Difference in circumference reduction between baseline and follow-up visits (time frame: Base line, 2 and 12 weeks post 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 3 Jun 2014; AzTrials last refreshed its copy on 6 Nov 2026.