Unwanted FatNCT02711618
Non-Invasive Abdominal Fat Reduction With BMI Above 28
A study testing UltraShape Contour I V3 in people with Unwanted Fat, run by Syneron Medical at 3 sites in United States.
Trial summary
Prospective, one arm, baseline-controlled clinical study for the evaluation of UltraShape contour I V3 for non-invasive fat reduction. The study will conduct using the UltraShape contour I V3 using U-Sculpt/VDF transducer on the abdomen. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Unwanted Fat
- What is being tested?
- UltraShape Contour I V3
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 3 sitesUnited States
- Study dates
- 29 Oct 2015to Nov 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
- subject is eligible to participate in the study if he or she meets all the following inclusion criteria:
- 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.
- Abdominal fat thickness of at least 1.5 cm (measured by calibrated caliper).
- BMI above 28 (normal to overweight).
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- 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).
- Negative urine pregnancy test as tested before the first treatment for women with bearing potential (e.g. not menopause). In addition, negative pregnancy following pregnancy inquiry for each visit (treatments and follow up), starting from the second treatment.
- 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
- A subject is not eligible for participation in this study if he/she meets any of the following exclusion criteria:
- History of hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker/defibrillator, abdominal aortic aneurism
- Current hyperlipidemia, hepatitis, liver disease, HIV positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease or malignancy
- Previous liposuction or body contouring procedures in the treatment areas of the abdomen or flanks. 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.
- 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 percent weight change in the prior six months).
- Inability to comply with circumference measurement procedure (e.g., inability to hold breath for the required duration).
- Abdominal fat thickness lower than 2.5 cm after strapping.
- Participation in another clinical study within the last 6 months.
- Non-invasive body-contouring procedures in the treatment area completed less than twelve months prior to study enrollment.
- 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.
United States3 sites
Sanctuary Plastic Surgery
Boca Raton, Florida, 33431
833 Northern Boulevard
Great Neck, New York, 11021
Laser and Skin Surgery Center
New York, New York, 10016
About this study
Official title: Clinical Study to Evaluate the Performance of the UltraShape Contour I V3 for Non-Invasive Abdominal Fat Reduction Among Patients With BMI Above 28
Prospective, one arm, baseline-controlled clinical study for the evaluation of UltraShape contour I V3 for non-invasive fat reduction.
The study will conduct using the UltraShape contour I V3 using U-Sculpt/VDF transducer on the abdomen.
Read the detailed description
This study is a prospective, one arm, up to four sites, clinical study showing the performance and safety of the UltraShape contour I V3 device non-invasive abdominal fat reduction for subjects with body mass index (BMI) above 28.
Up to 60 healthy subjects will be enrolled. All subjects will undergo an assessment of their general health. During the treatment period, subject's fat thickness and circumferences will be measured and three successive UltraShape contour I V3 treatments will be performed (two weeks interval).
Subjects will undergo treatment with the UltraShape contour I V3 using the U-Sculpt/VDF transducer on the abdomen area.
Follow-up (FU) visits will be conducted as follows: 4 weeks FU, 8 weeks FU and 12 weeks FU post last treatment (Tx.3). Subject's fat thickness and circumference will be measured at each visit. Subject's blood test will be taken at baseline (prior to the first treatment, pre Tx.1), before the third treatment (pre Tx.3) and at 12 weeks follow-up visit (12wk FU). "No Pregnancy" will be verified before first treatment as well. In all following visits (TX2, Tx3 and FU 1 FU 2 and FU3), lack of pregnancy will be verified by questioning. Additionally, subject satisfaction and investigator satisfaction questionnaires will be completed at each FU visit. Finally, photography will be performed under visible light conditions of the front, right and left view. Optional, 3D photographs will be taken at each visit (at treatment visits, prior to treatments).
- Conditions
- Unwanted Fat
- Being tested
- UltraShape Contour I V3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltraShape Contour I V3Device
Also called Contour I V3
Tissue selectivity is achieved by a proprietary knowledge of parameters ensuring specific destruction of the fat cells only within the target area. 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
| Study group | Role | What they receive |
|---|---|---|
| UltraShape Contour I V3 treatment | Experimental | Up to 60 healthy adult volunteers seeking noninvasive fat reduction, male and females at up to four sites, age of 18 to 60, with BMI above 28 Receives: Device: UltraShape Contour I V3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in abdominal fat thickness compared to baseline
Abdominal fat thickness reduction post UltraShape contour I V3 treatments at 12 weeks follow-up (12wk FU) versus baseline.
Measured: Baseline and 12 weeks
Secondary outcomes (7)
Change in abdominal fat thickness compared to baseline
Abdominal fat thickness reduction as measured by Ultrasound device post UltraShape contour I V3 treatments at follow-up visits
Measured: Baseline, 8 weeks and 16 weeks
Change in abdominal fat thickness compared to baseline
Abdominal fat thickness reduction as measured by caliper post UltraShape contour I V3 treatments at follow-up visits versus baseline
Measured: Baseline, 8 weeks, 12 weeks, and 16 weeks
Change in abdominal circumference reduction compared to baseline
Abdominal circumference reduction post UltraShape contour I V3 treatments at all treatment visits and follow-up visits
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Blood panel and fat lipid profile compared to baseline levels
Blood elements levels (e.g. lipids, Glucose) before the third treatment (at 4 weeks) and at the last follow-up visit (at 16 weeks) versus baseline
Measured: Baseline, 4 weeks and 16 weeks
Investigator satisfaction
Investigator satisfaction: success is defined as when at least 50% of the observations are ranked as at least satisfied by the study investigator at each of the follow up visits
Measured: 8 weeks, 12 weeks, and 16 weeks
Subject satisfaction
Subject satisfaction: success is defined as when at least 50% of the subjects are satisfied with treatment results at each of the follow up visits
Measured: 8 weeks, 12 weeks, and 16 weeks
Comfort level during treatment
Comfort assessment will be performed independently by subjects using a numerical scale. Subjects will assess treatment comfort immediately post each of the three treatments
Measured: day 0, 2 weeks, and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study start29 Oct 2015
- Primary completionOct 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unwanted 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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syneron Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alan H Gold, M.D., Principal investigator, Aesthetic Plastic Surgery & Cosmetic Medicine Great Neck, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02711618
- Sponsor's protocol ID
- DHF19571
- Status last verified
- Apr 2017
- First submitted
- 25 Feb 2016
- Last updated
- 6 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Arner P. Regional adipocity in man. J Endocrinol. 1997 Nov;155(2):191-2. doi: 10.1677/joe.0.1550191. No abstract available.
PubMed 9415044
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Performance of the UltraShape Contour I V3 for Non-Invasive Abdominal Fat Reduction Among Patients With BMI Above 28
- ClinicalTrials.gov ID
- NCT02711618
- Acronym / sponsor ID
- DHF19571
- Conditions
- Unwanted Fat
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Syneron MedicalIndustry (pharma, biotech, devices)
- Study start
- 29 Oct 2015 (actual)
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 17 Mar 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, one arm, baseline-controlled clinical study for the evaluation of UltraShape contour I V3 for non-invasive fat reduction.
The study will conduct using the UltraShape contour I V3 using U-Sculpt/VDF transducer on the abdomen.
Detailed description
This study is a prospective, one arm, up to four sites, clinical study showing the performance and safety of the UltraShape contour I V3 device non-invasive abdominal fat reduction for subjects with body mass index (BMI) above 28.
Up to 60 healthy subjects will be enrolled. All subjects will undergo an assessment of their general health. During the treatment period, subject's fat thickness and circumferences will be measured and three successive UltraShape contour I V3 treatments will be performed (two weeks interval).
Subjects will undergo treatment with the UltraShape contour I V3 using the U-Sculpt/VDF transducer on the abdomen area.
Follow-up (FU) visits will be conducted as follows: 4 weeks FU, 8 weeks FU and 12 weeks FU post last treatment (Tx.3). Subject's fat thickness and circumference will be measured at each visit. Subject's blood test will be taken at baseline (prior to the first treatment, pre Tx.1), before the third treatment (pre Tx.3) and at 12 weeks follow-up visit (12wk FU). "No Pregnancy" will be verified before first treatment as well. In all following visits (TX2, Tx3 and FU 1 FU 2 and FU3), lack of pregnancy will be verified by questioning. Additionally, subject satisfaction and investigator satisfaction questionnaires will be completed at each FU visit. Finally, photography will be performed under visible light conditions of the front, right and left view. Optional, 3D photographs will be taken at each visit (at treatment visits, prior to treatments).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UltraShape Contour I V3 treatment | Experimental | Device: UltraShape Contour I V3Up to 60 healthy adult volunteers seeking noninvasive fat reduction, male and females at up to four sites, age of 18 to 60, with BMI above 28 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- subject is eligible to participate in the study if he or she meets all the following inclusion criteria:
- 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.
- Abdominal fat thickness of at least 1.5 cm (measured by calibrated caliper).
Key exclusion criteria (16 listed)
- A subject is not eligible for participation in this study if he/she meets any of the following exclusion criteria:
- History of hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker/defibrillator, abdominal aortic aneurism
- Current hyperlipidemia, hepatitis, liver disease, HIV positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease or malignancy
- Previous liposuction or body contouring procedures in the treatment areas of the abdomen or flanks. 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 |
|---|---|---|
| UltraShape Contour I V3Also: Contour I V3Tissue selectivity is achieved by a proprietary knowledge of parameters ensuring specific destruction of the fat cells only within the target area. 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 | Device | UltraShape Contour I V3 treatment |
Primary outcome
Change in abdominal fat thickness compared to baseline
Time frame: Baseline and 12 weeks
Abdominal fat thickness reduction post UltraShape contour I V3 treatments at 12 weeks follow-up (12wk FU) versus baseline.
7 secondary outcomes
Change in abdominal fat thickness compared to baseline
Time frame: Baseline, 8 weeks and 16 weeks
Change in abdominal fat thickness compared to baseline
Time frame: Baseline, 8 weeks, 12 weeks, and 16 weeks
Change in abdominal circumference reduction compared to baseline
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Blood panel and fat lipid profile compared to baseline levels
Time frame: Baseline, 4 weeks and 16 weeks
Investigator satisfaction
Time frame: 8 weeks, 12 weeks, and 16 weeks
Subject satisfaction
Time frame: 8 weeks, 12 weeks, and 16 weeks
Comfort level during treatment
Time frame: day 0, 2 weeks, and 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2017.
- Background: PubMed 9415044Arner P. Regional adipocity in man. J Endocrinol. 1997 Nov;155(2):191-2. doi: 10.1677/joe.0.1550191. No abstract available.
- Individual participant dataSharing planned: Undecided
Related trials for Unwanted Fat
Not yet recruitingObservational study
Quantified Evaluation of Noninvasive System Delivering Microwave Energy for Unwanted Fat Reduction and Skin Tightening in Asians.
Facial Aging, Skin Laxity
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.
Alan H Gold, M.D. principal investigator
Aesthetic Plastic Surgery & Cosmetic Medicine Great Neck, New York
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 Contour I V3 in people with Unwanted 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 12 inclusion and 16 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 6 Apr 2017. 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?
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?
Change in abdominal fat thickness compared to baseline (time frame: Baseline and 12 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 NCT02711618, which also lists 1 linked publication.
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 Apr 2017.