Body SculptingNCT01462201
A Multicenter,2-Arm,Randomized,Controlled Study Evaluate the Effectiveness of the UltraShape® Contour I VER 3.1 System for Non-Invasive Reduction in Abdominal Circumference
A study testing Non Invasive Ultrasound in people with Body Sculpting, run by UltraShape at 5 sites in 2 countries.
Trial summary
The primary objective of this study is to evaluate the effectiveness of the Contour I VER 3.1 System on abdominal midsection circumference reduction relative to no treatment. The secondary objective of this study is to assess subject satisfaction measured with a self-assessment questionnaire Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Sculpting
- What is being tested?
- Non Invasive Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Jul 2012to Oct 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
- Female or male subjects, 18 and 65 years of age at the time of enrollment
- Abdominal fat thickness of at least 1.5 cm (measurement by caliper)
- For women of child-bearing potential:
- negative urine pregnancy test.
- Women of child bearing age are required to be using an acceptable form of birth control for the duration of the study.
- General good health confirmed by medical history and skin examination of the treated area
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- Written informed consent to participate in the study
- Ability to comply with the requirements of the study
- BMI ≤ 30
- Intra-procedural Inclusion criteria (prior to starting the treatment phase):
- subjects are eligible to continue the study and participate in the treatment phase if she meets all of the following intra-procedural inclusion criteria:
- For women of child-bearing potential: negative pregnancy test
- Abdominal fat thickness of at least 1.5 cm prior to initial treatment (measurement by caliper)
Who cannot join
- History of hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker/defibrillator, abdominal aortic aneurysm
- 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 area
- 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)
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- 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 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 held breath for the required duration)
- Participation in another clinical study within the last six months.
- Previous body contouring treatments in the areas of the abdomen and flanks.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
Dr. Jeffrey Kenkel
Dallas, Texas, 75390-9132
MD Laser Skin & Vein Institute
Hunt Valley, Maryland, 21030
Dr. William Patrick Coleman, III
Metairie, Louisiana, 70006
New-Jersey Plastic Surgery
Montclair, New Jersey, 07042
Israel1 site
Department of Plastic Surgery and Burns Rabin Medical Center - Beilinson Hospital
Petah Tikva, 49100
About this study
Official title: A Multicenter,Two-Arm,Randomized,Controlled Study for the Evaluation of the Treatment of Adipose Tissue Using a Focused Ultrasound Device
The primary objective of this study is to evaluate the effectiveness of the Contour I VER 3.1 System on abdominal midsection circumference reduction relative to no treatment.
The secondary objective of this study is to assess subject satisfaction measured with a self-assessment questionnaire
- Conditions
- Body Sculpting
- Being tested
- Non Invasive Ultrasound
- Keywords
- focused ultrasound, mechanical fat destruction, Body Sculpting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non Invasive UltrasoundDevice
Each treatment session is estimated to take approximately 60 minutes and will be performed on a bi-weekly basis.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Non Invasive Ultrasound | Experimental | Group 1 3 visits - Measurement of abdominal circumferences 3 visits - Treatment with Ultrashape Contour I VER 3.1 4 visits - Follow up visits The intervention is non invasive ultrasound. Receives: Device: Non Invasive Ultrasound |
| Group 2 - Non Invasive Ultrasound | Experimental | Group 2 3 visits - Treatment with Contour I VER 3.1 system 3 visits - Measurements of abdominal circumference 4 visits - Follow Up visits The intervention is non invasive ultrasound. Receives: Device: Non Invasive Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to evaluate the effectiveness of the Contour I VER 3.1 System on abdominal midsection circumference reduction relative to no treatment
Reduction in circumference measurement of the abdomen from baseline
Measured: 5-6 months
Secondary outcomes (1)
Assess subject satisfaction measured with a self-assessment questionnaire
Measured: 5-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2011 (estimated)
- Study startJul 2012
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body SculptingStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- UltraShape
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syneron Medical
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01462201
- Sponsor's protocol ID
- US-0711
- Status last verified
- Nov 2013
- First submitted
- 17 Oct 2011
- Last updated
- 13 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter,Two-Arm,Randomized,Controlled Study for the Evaluation of the Treatment of Adipose Tissue Using a Focused Ultrasound Device
- ClinicalTrials.gov ID
- NCT01462201
- Acronym / sponsor ID
- US-0711
- Conditions
- Body Sculpting
- Keywords
- focused ultrasound, mechanical fat destruction, Body Sculpting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- UltraShapeIndustry (pharma, biotech, devices)
- Collaborators
- Syneron Medical
- Study start
- Jul 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 31 Oct 2011 (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 primary objective of this study is to evaluate the effectiveness of the Contour I VER 3.1 System on abdominal midsection circumference reduction relative to no treatment.
The secondary objective of this study is to assess subject satisfaction measured with a self-assessment questionnaire
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Non Invasive Ultrasound | Experimental | Device: Non Invasive UltrasoundGroup 1 3 visits - Measurement of abdominal circumferences 3 visits - Treatment with Ultrashape Contour I VER 3.1 4 visits - Follow up visits The intervention is non invasive ultrasound. |
| Group 2 - Non Invasive Ultrasound | Experimental | Device: Non Invasive UltrasoundGroup 2 3 visits - Treatment with Contour I VER 3.1 system 3 visits - Measurements of abdominal circumference 4 visits - Follow Up visits The intervention is non invasive ultrasound. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Female or male subjects, 18 and 65 years of age at the time of enrollment
- Abdominal fat thickness of at least 1.5 cm (measurement by caliper)
- For women of child-bearing potential:
- General good health confirmed by medical history and skin examination of the treated area
- Written informed consent to participate in the study
Key exclusion criteria (15 listed)
- History of hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker/defibrillator, abdominal aortic aneurysm
- 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 area
- 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 |
|---|---|---|
| Non Invasive UltrasoundEach treatment session is estimated to take approximately 60 minutes and will be performed on a bi-weekly basis. | Device | Group 1 - Non Invasive Ultrasound, Group 2 - Non Invasive Ultrasound |
Primary outcome
The primary objective of this study is to evaluate the effectiveness of the Contour I VER 3.1 System on abdominal midsection circumference reduction relative to no treatment
Time frame: 5-6 months
Reduction in circumference measurement of the abdomen from baseline
1 secondary outcome
Assess subject satisfaction measured with a self-assessment questionnaire
Time frame: 5-6 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 13 Nov 2013.
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.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non Invasive Ultrasound in people with Body Sculpting, run by UltraShape at 5 sites in 2 countries.
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 13 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 13 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, 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?
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?
The primary objective of this study is to evaluate the effectiveness of the Contour I VER 3.1 System on abdominal midsection circumference reduction relative to no treatment (time frame: 5-6 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 13 Nov 2013.