Excess Abdominal FatNCT03502473
UltraShape Power Device for Fat Reduction in Flanks
A study testing UltraShape Power device in people with Excess Abdominal Fat, run by Syneron Medical at 1 site in Israel.
Trial summary
Prospective, baseline-controlled evaluation of the UltraShape Power device for non-invasive fat reduction in flanks. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Excess Abdominal Fat
- What is being tested?
- UltraShape Power device
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- 7 Mar 2018to 7 Sep 2019
- 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
- Signed informed consent to participate in the study.
- Female and male subjects, 18 and 65 years of age at the time of enrolment
- Fitzpatrick Skin Type I to VI.
- Fat thickness of at least 1.5 cm in the treated area (measured by calibrated caliper).
- BMI interval: 19 ≤ BMI ≤ 30 (normal to overweight, but not obese).
- 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).
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- In addition, negative pregnancy inquiry as reviewed before each treatment and each follow up visit for women with bearing potential (e.g. not menopause).
- 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
- Current 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 3 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
- 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 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)
- 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 fat measurement procedures (e.g., inability to hold breath for few seconds).
- Fat thickness lower than 1.5 cm before strapping at the treated area.
- Participation in another clinical study involving same anatomical areas within the last 6 months (or 30 days in case different anatomical areas were treated in previous trial/s).
- 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.
About this study
Official title: Clinical Assessment to Evaluate UltraShape Power Device Performance for Flanks Fat Reduction
Prospective, baseline-controlled evaluation of the UltraShape Power device for non-invasive fat reduction in flanks.
Read the detailed description
Eligible subjects will receive 3 bi-weekly treatments (2 weeks interval) with the UltraShape Power device according to the study protocol.
One random flank will be treated with one pass or remained as a control (no treatment) while the second flank will be treated with multiple passes.
Subjects will return for up to 4 follow up visits: 4 weeks, 8 weeks, 12 weeks and (optional) 24 weeks following end of treatment/s.
Each subject will be enrolled for total expected study duration of up to 28 weeks.
After last follow up visit, subjects who wish will receive compensation treatments (up to 3) on the flank who received regular treatment (single pass) or remained as a control (no treatment).
- Conditions
- Excess Abdominal Fat
- Being tested
- UltraShape Power device
- Keywords
- fat flanks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltraShape Power deviceDevice
UltraShape Power is a non-invasive focused ultrasound device, approved by the FDA (160896K;170370K); CE; Israeli Ministry of Health. The UltraShape Power system works by emitting acoustic waves of focused ultrasonic energy (200 ± 30 KHz frequency) that converge into a confined focal volume underneath the skin, thereby, targeting only subcutaneous fat at a controlled depth. Unlike traditional ultrasound technology, UltraShape Power's energy transmits pulsed ultrasound, allowing control over temperature elevation. The system comprised of two main parts:
- The Main console
- Transducer
| Study group | Role | What they receive |
|---|---|---|
| One pass/no treatment arm | Experimental | One random flank will be treated with UltraShape Power device with one pass or remained as a control (no treatment) Receives: Device: UltraShape Power device |
| Multiple passes treatment arm | Experimental | Second flank will be treated with UltraShape Power device with multiple passes. Receives: Device: UltraShape Power device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat Volume reduction
MRI measurements for fat thickness in cc (cubic centimeter)
Measured: 12 weeks follow-up (12wk FU) versus baseline
Treatment Safety as Assessed by Blood Lipid Level
Verification similar of post-treatment and pre-treatment (baseline) blood lipid levels values [%]
Measured: up to 24 weeks
Secondary outcomes (3)
MRI Measurement of Fat Thickness Reduction
MRI measurements for Fat thickness in mm
Measured: 4 weeks, 8 weeks, 12 weeks and (optional) 24 weeks versus baseline.
Ultrasound Measurement of Fat Thickness Reduction
Ultrasound measurements for Fat thickness in mm
Measured: 4 weeks, 8 weeks, 12 weeks and (optional) 24 weeks versus baseline.
Fat Volume reduction
MRI measurements for fat thickness in cc (cubic centimeter)
Measured: 4 weeks, 8 weeks and (optional) 24 weeks versus baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start7 Mar 2018
- Primary completion7 Mar 2019 (estimated)
- Study completion7 Sep 2019 (estimated)
Why it stopped: Sponsor decision was made not to initiate and to focus on other initiatives
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Excess 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
- Model description
- Flanks will be randomized in accordance with randomization list. One flank will receive a single treatment pass or no treatment. The other side will receive multiple passes (up to 5 passes) during the same treatment session.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syneron Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Jerdev, MD, Principal investigator, The Baruch Padeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03502473
- Sponsor's protocol ID
- DHF24961
- Status last verified
- Jan 2020
- First submitted
- 20 Mar 2018
- Last updated
- 6 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment to Evaluate UltraShape Power Device Performance for Flanks Fat Reduction
- ClinicalTrials.gov ID
- NCT03502473
- Acronym / sponsor ID
- DHF24961
- Conditions
- Excess Abdominal Fat
- Keywords
- fat flanks
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decision was made not to initiate and to focus on other initiatives
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Syneron MedicalIndustry (pharma, biotech, devices)
- Study start
- 7 Mar 2018 (actual)
- Primary completion
- 7 Mar 2019 (estimated)
- Study completion
- 7 Sep 2019 (estimated)
- First posted
- 18 Apr 2018 (actual)
- 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, baseline-controlled evaluation of the UltraShape Power device for non-invasive fat reduction in flanks.
Detailed description
Eligible subjects will receive 3 bi-weekly treatments (2 weeks interval) with the UltraShape Power device according to the study protocol.
One random flank will be treated with one pass or remained as a control (no treatment) while the second flank will be treated with multiple passes.
Subjects will return for up to 4 follow up visits: 4 weeks, 8 weeks, 12 weeks and (optional) 24 weeks following end of treatment/s.
Each subject will be enrolled for total expected study duration of up to 28 weeks.
After last follow up visit, subjects who wish will receive compensation treatments (up to 3) on the flank who received regular treatment (single pass) or remained as a control (no treatment).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Flanks will be randomized in accordance with randomization list. One flank will receive a single treatment pass or no treatment. The other side will receive multiple passes (up to 5 passes) during the same treatment session.
| Arm | Type | Receives |
|---|---|---|
| One pass/no treatment arm | Experimental | Device: UltraShape Power deviceOne random flank will be treated with UltraShape Power device with one pass or remained as a control (no treatment) |
| Multiple passes treatment arm | Experimental | Device: UltraShape Power deviceSecond flank will be treated with UltraShape Power device with multiple passes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Signed informed consent to participate in the study.
- Female and male subjects, 18 and 65 years of age at the time of enrolment
- Fitzpatrick Skin Type I to VI.
- Fat thickness of at least 1.5 cm in the treated area (measured by calibrated caliper).
- BMI interval: 19 ≤ BMI ≤ 30 (normal to overweight, but not obese).
Key exclusion criteria (20 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
- 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 |
|---|---|---|
| UltraShape Power deviceUltraShape Power is a non-invasive focused ultrasound device, approved by the FDA (160896K;170370K); CE; Israeli Ministry of Health. The UltraShape Power system works by emitting acoustic waves of focused ultrasonic energy (200 ± 30 KHz frequency) that converge into a confined focal volume underneath the skin, thereby, targeting only subcutaneous fat at a controlled depth. Unlike traditional ultrasound technology, UltraShape Power's energy transmits pulsed ultrasound, allowing control over temperature elevation. The system comprised of two main parts: * The Main console * Transducer | Device | Multiple passes treatment arm, One pass/no treatment arm |
Primary outcome
Fat Volume reduction
Time frame: 12 weeks follow-up (12wk FU) versus baseline
MRI measurements for fat thickness in cc (cubic centimeter)
Treatment Safety as Assessed by Blood Lipid Level
Time frame: up to 24 weeks
Verification similar of post-treatment and pre-treatment (baseline) blood lipid levels values [%]
3 secondary outcomes
MRI Measurement of Fat Thickness Reduction
Time frame: 4 weeks, 8 weeks, 12 weeks and (optional) 24 weeks versus baseline.
Ultrasound Measurement of Fat Thickness Reduction
Time frame: 4 weeks, 8 weeks, 12 weeks and (optional) 24 weeks versus baseline.
Fat Volume reduction
Time frame: 4 weeks, 8 weeks and (optional) 24 weeks versus baseline.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2020.
- Individual participant dataSharing planned: No
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.
Michael Jerdev, MD principal investigator
The Baruch Padeh Medical Center
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 device in people with Excess Abdominal Fat, run by Syneron Medical 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 11 inclusion and 20 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: withdrawn, as of the sponsor's last update on 6 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 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 was withdrawn before enrolling participants, so there are no results.
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?
Fat Volume reduction (time frame: 12 weeks follow-up (12wk FU) versus baseline). 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 6 Jan 2020.