Unwanted Thigh FatNCT02488083
UltraShape Device for Thigh Fat and Circumference Reduction vs. Control
A study testing Ultrashape in people with Unwanted Thigh Fat, run by Syneron Medical at 3 sites in United States.
Trial summary
UltraShape Device for Thigh Fat and Circumference Reduction: Prospective, blinded, one arm, baseline-controlled clinical study for the evaluation of the UltraShape treatment for non-invasive fat and circumference reduction. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Unwanted Thigh Fat
- What is being tested?
- Ultrashape
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2015to Mar 2017
- 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
- Signed informed consent to participate in the study.
- Female and male subjects,18 and 60 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: BMI in range of 22- 30 (normal to overweight, but not obese).
- If female, not pregnant or lactating, 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 follow-up visit for women with child-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
- 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
- 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 bigger than 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 tolerance of 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).
- 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
3 sites in 1 country.
Robert Weiss, MD contact
United States3 sites, 2 recruiting
- Recruiting
Maryland Laser, Skin, & Vein Institute
Baltimore, Maryland, 21030
Robert Weiss, MD, 410-666-3960, info@mdlsv.com
- Completed
Skin Laser & Surgery Specialist of NY/NJ
Hackensack, New Jersey, 07601
- Recruiting
Coleman Center for Cosmetic Dermatologic Surgery
Metairie, Louisiana, 70006
William P Coleman, MD, 504-455-3180
William P Coleman, MD
About this study
Official title: Clinical Study to Evaluate the Performance of the UltraShape Device for Thighs Fat and Circumference Reduction vs. Control
UltraShape Device for Thigh Fat and Circumference Reduction: Prospective, blinded, one arm, baseline-controlled clinical study for the evaluation of the UltraShape treatment for non-invasive fat and circumference reduction.
Read the detailed description
UltraShape Device for Thigh Fat and Circumference Reduction- Up to 60 healthy adult volunteers seeking for noninvasive thighs circumference reduction, male and females, 18 to 60 years of age from up to four investigational sites.
Eligible subjects will receive 3 bi-weekly treatments (2 weeks interval) on one randomized thigh with the UltraShape device according to the study protocol. The other thigh will not be treated during the main study phase (and serve as control).
The subjects will return for 3 follow up visits: four weeks (4wk FU), eight weeks (8wk FU) and 16 weeks (16wk FU) after the last treatment.
Total expected study duration: 20-22 weeks. Should the subject choose to receive additional optional treatments on the untreated side, up to three bi-weekly treatments will be performed upon study completion at no cost to the subject while changing total study duration to 24-26 weeks.
- Conditions
- Unwanted Thigh Fat
- Being tested
- Ultrashape
- Keywords
- non-invasive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrashapeDevice
Also called fat reduction
circumference reduction
| Study group | Role | What they receive |
|---|---|---|
| all subjects treated by UltraShape | Experimental | all the patients undergo fat reduction treatment by UltraShape Receives: Device: Ultrashape |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the efficacy of the UltraShape device by evaluating the non-invasive fat and circumference reduction
Measured: 8 weeks up to 20 weeks
Secondary outcomes (7)
safety issues assessed by The number, severity and type of any adverse event recorded throughout the study and post treatment (immediate and delayed response)
Measured: day 0 up to 20 weeks
thigh circumference reduction
significant thigh circumference reduction post UltraShape treatments. Reduction will be calculated at each follow-up visit (4wk FU, 8wk FU and 16wk FU) versus baseline and versus control thigh.
Measured: four weeks (4wk FU), eight weeks (8wk FU) and 16 weeks (16wk FU) after the last treatment,
thigh fat thickness reduction by ultrasound
fat thickness reduction post UltraShape treatments as measured by caliper and by Ultrasound device
Measured: day 0, 2 weeks, 4 weeks, 8 weeks, 12 weeks, 20 weeks
thigh fat thickness reduction by caliper
thigh fat thickness reduction
Measured: day 0, 2 weeks, 4 weeks, 8 weeks, 12 weeks, 20 weeks
Subject satisfaction by questionnaire
Satisfaction assessment will be performed independently by the subject himself
Measured: 8 weeks, 12 weeks, 20 weeks
Comfort level by NSR scale
Comfort level during treatment will be performed post each treatment
Measured: day 0, 2 weeks, 4 weeks
Investigator satisfaction by questionnaire
assessment comparing before and after photos using the 5-Point Likert Scale
Measured: 8 weeks, 12 weeks, 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2016 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Unwanted Thigh 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Syneron Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Weiss, MD, Principal investigator, Maryland Laser Skin and Vein Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02488083
- Sponsor's protocol ID
- DHF17991
- Status last verified
- Apr 2016
- First submitted
- 26 May 2015
- Last updated
- 14 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Ascher B. Safety and efficacy of UltraShape Contour I treatments to improve the appearance of body contours: multiple treatments in shorter intervals. Aesthet Surg J. 2010 Mar;30(2):217-24. doi: 10.1177/1090820X09360692.
PubMed 20442099Teitelbaum SA, Burns JL, Kubota J, Matsuda H, Otto MJ, Shirakabe Y, Suzuki Y, Brown SA. Noninvasive body contouring by focused ultrasound: safety and efficacy of the Contour I device in a multicenter, controlled, clinical study. Plast Reconstr Surg. 2007 Sep;120(3):779-789. doi: 10.1097/01.prs.0000270840.98133.c8.
PubMed 17700131
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Performance of the UltraShape Device for Thighs Fat and Circumference Reduction vs. Control
- ClinicalTrials.gov ID
- NCT02488083
- Acronym / sponsor ID
- DHF17991
- Conditions
- Unwanted Thigh Fat
- Keywords
- non-invasive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Syneron MedicalIndustry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 2 Jul 2015 (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.
UltraShape Device for Thigh Fat and Circumference Reduction: Prospective, blinded, one arm, baseline-controlled clinical study for the evaluation of the UltraShape treatment for non-invasive fat and circumference reduction.
Detailed description
UltraShape Device for Thigh Fat and Circumference Reduction- Up to 60 healthy adult volunteers seeking for noninvasive thighs circumference reduction, male and females, 18 to 60 years of age from up to four investigational sites.
Eligible subjects will receive 3 bi-weekly treatments (2 weeks interval) on one randomized thigh with the UltraShape device according to the study protocol. The other thigh will not be treated during the main study phase (and serve as control).
The subjects will return for 3 follow up visits: four weeks (4wk FU), eight weeks (8wk FU) and 16 weeks (16wk FU) after the last treatment.
Total expected study duration: 20-22 weeks. Should the subject choose to receive additional optional treatments on the untreated side, up to three bi-weekly treatments will be performed upon study completion at no cost to the subject while changing total study duration to 24-26 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all subjects treated by UltraShape | Experimental | Device: Ultrashapeall the patients undergo fat reduction treatment by UltraShape |
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 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: BMI in range of 22- 30 (normal to overweight, but not obese).
Key exclusion criteria (19 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 |
|---|---|---|
| UltrashapeAlso: fat reductioncircumference reduction | Device | all subjects treated by UltraShape |
Primary outcome
evaluate the efficacy of the UltraShape device by evaluating the non-invasive fat and circumference reduction
Time frame: 8 weeks up to 20 weeks
7 secondary outcomes
safety issues assessed by The number, severity and type of any adverse event recorded throughout the study and post treatment (immediate and delayed response)
Time frame: day 0 up to 20 weeks
thigh circumference reduction
Time frame: four weeks (4wk FU), eight weeks (8wk FU) and 16 weeks (16wk FU) after the last treatment,
thigh fat thickness reduction by ultrasound
Time frame: day 0, 2 weeks, 4 weeks, 8 weeks, 12 weeks, 20 weeks
thigh fat thickness reduction by caliper
Time frame: day 0, 2 weeks, 4 weeks, 8 weeks, 12 weeks, 20 weeks
Subject satisfaction by questionnaire
Time frame: 8 weeks, 12 weeks, 20 weeks
Comfort level by NSR scale
Time frame: day 0, 2 weeks, 4 weeks
Investigator satisfaction by questionnaire
Time frame: 8 weeks, 12 weeks, 20 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
- Background: PubMed 20442099Ascher B. Safety and efficacy of UltraShape Contour I treatments to improve the appearance of body contours: multiple treatments in shorter intervals. Aesthet Surg J. 2010 Mar;30(2):217-24. doi: 10.1177/1090820X09360692.
- Background: PubMed 17700131Teitelbaum SA, Burns JL, Kubota J, Matsuda H, Otto MJ, Shirakabe Y, Suzuki Y, Brown SA. Noninvasive body contouring by focused ultrasound: safety and efficacy of the Contour I device in a multicenter, controlled, clinical study. Plast Reconstr Surg. 2007 Sep;120(3):779-789. doi: 10.1097/01.prs.0000270840.98133.c8.
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.
Robert Weiss, MD contact
Robert Weiss, MD principal investigator
Maryland Laser Skin and Vein Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrashape in people with Unwanted Thigh Fat, run by Syneron Medical at 3 sites 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 19 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 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert Weiss, MD (410-666-3960), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate the efficacy of the UltraShape device by evaluating the non-invasive fat and circumference reduction (time frame: 8 weeks up to 20 weeks). 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 NCT02488083, which also lists 2 linked publications.
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 14 Apr 2016.