Unwanted Flanks FatNCT02465762
UltraShape Device Using the U-Sculpt/VDF Transducer for Flanks Fat
A study testing ultrashape Fat reduction in people with Unwanted Flanks Fat, run by Syneron Medical.
Trial summary
Prospective, blinded, one arm, baseline-controlled clinical study for the evaluation of the UltraShape treatment for non-invasive fat and circumference reduction. Study subjects will undergo UltraShape treatments on the flanks area using the U-Sculpt/VDF Transducer - 60 subjects. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Unwanted Flanks Fat
- What is being tested?
- ultrashape Fat reduction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Jul 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, between 18 to 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 between 22 to 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 above 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 hold breath for the required duration).
- Fat thickness lower than 2.5 cm after 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.
About this study
Official title: Clinical Study to Evaluate the Safety and Efficacy of the UltraShape Device Using the U-Sculpt/VDF Transducer for Flanks 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.
Study subjects will undergo UltraShape treatments on the flanks area using the U-Sculpt/VDF Transducer - 60 subjects.
Read the detailed description
This study is a prospective, baseline and blinded controlled, one arm clinical study showing the performance and safety of the UltraShape treatment for non-invasive fat and circumference reduction at the flanks area.
Up to 60 Healthy subjects in up to 4 investigational sites will be enrolled in this study. All subjects will undergo an assessment of their general health. During the treatment period, subject's circumference and fat thickness will be measured and three successive bi-weekly (two weeks interval) UltraShape treatments will be performed.
The study subjects will undergo UltraShape treatments on the flanks area using the U-Sculpt /VDF Transducer.
During the follow-up period visit will be conducted as follow: 4 weeks (4wk FU), 8 weeks (8wk FU) and 16 weeks (16wk FU) post last treatment (Tx.3). Subject's circumference will be measured in the measurements points according to the flanks treated area, circumference reduction will be assessed at each visit. Additionally, a subject questionnaire will be completed in each follow-up visit. Finally, photography will be performed under visible light conditions of the front, right, left and back view. Most of the assessments will occur at each of the visits to the clinic.
- Conditions
- Unwanted Flanks Fat
- Being tested
- ultrashape Fat reduction
- Keywords
- non-invasive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrashape Fat reductionDevice
Also called Ultrashape
Ultrashape Device focused ultrasound to produce localized mechanical motion within fat tissues and cells for the purpose of producing mechanical cellular membrane disruption. It is intended for reduction in abdominal circumference.
| Study group | Role | What they receive |
|---|---|---|
| ultrashape fat reduction treatment | Experimental | all patient undergo non-invasive fat and circumference reduction at the flanks area Receives: Device: ultrashape Fat reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy flanks fat reduction
measure by caliper and Ultrasound
Measured: 4, 8 and 16 weeks post last treatment (Tx.3)
Secondary outcomes (6)
circumference reduction post UltraShape treatments
Reduction will be calculated
Measured: 4, 8 and 16 weeks post last treatment (Tx.3)
fat thickness reduction
by caliper and by Ultrasound device
Measured: 4, 8 and 16 weeks post last treatment (Tx.3)
Investigator satisfaction assessment
5-Point Likert Scale
Measured: 4, 8 and 16 weeks post last treatment (Tx.3)
Subject satisfaction assessment
The subjects will answer the questionnaire
Measured: 4, 8 and 16 weeks post last treatment (Tx.3)
Comfort level
using NSR scale
Measured: day 0, after 2 and 4 weeks
Evaluate the safety for flanks fat reduction
Evaluate the safety of the treatment with the UltraShape device using the U-Sculpt/VDF Transducer for flanks treatment area
Measured: up to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study startAug 2015
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
Why it stopped: Study design was amended to include a control - reregistered as NCT02465775
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Unwanted Flanks 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
- William P Coleman, MD, Principal investigator, Coleman Center for Cosmetic Dermatologic Surgery 4425 Conlin Street, Metairie, Louisiana 70006Michael Gold, MD, Principal investigator, Gold Skin Care Center, 2000 Richard Jones Road, Suite 220, Nashville, TN 37215 USARobert Weiss, MD, Principal investigator, 54 Scot Adams Road, Hunt Valley Baltimore USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02465762
- Sponsor's protocol ID
- DHF18001
- Status last verified
- Apr 2016
- First submitted
- 1 Jun 2015
- Last updated
- 14 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Adamo C, Mazzocchi M, Rossi A, Scuderi N. Ultrasonic liposculpturing: extrapolations from the analysis of in vivo sonicated adipose tissue. Plast Reconstr Surg. 1997 Jul;100(1):220-6. doi: 10.1097/00006534-199707000-00033.
PubMed 9207679Goldman A. Submental Nd:Yag laser-assisted liposuction. Lasers Surg Med. 2006 Mar;38(3):181-4. doi: 10.1002/lsm.20270.
PubMed 16453321Hexsel D, Serra M, Mazzuco R, Dal'Forno T, Zechmeister D. Phosphatidylcholine in the treatment of localized fat. J Drugs Dermatol. 2003 Oct;2(5):511-8.
PubMed 14558399
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 Safety and Efficacy of the UltraShape Device Using the U-Sculpt/VDF Transducer for Flanks Fat and Circumference Reduction
- ClinicalTrials.gov ID
- NCT02465762
- Acronym / sponsor ID
- DHF18001
- Conditions
- Unwanted Flanks Fat
- Keywords
- non-invasive
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Study design was amended to include a control - reregistered as NCT02465775
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Syneron MedicalIndustry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 8 Jun 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.
Prospective, blinded, one arm, baseline-controlled clinical study for the evaluation of the UltraShape treatment for non-invasive fat and circumference reduction.
Study subjects will undergo UltraShape treatments on the flanks area using the U-Sculpt/VDF Transducer - 60 subjects.
Detailed description
This study is a prospective, baseline and blinded controlled, one arm clinical study showing the performance and safety of the UltraShape treatment for non-invasive fat and circumference reduction at the flanks area.
Up to 60 Healthy subjects in up to 4 investigational sites will be enrolled in this study. All subjects will undergo an assessment of their general health. During the treatment period, subject's circumference and fat thickness will be measured and three successive bi-weekly (two weeks interval) UltraShape treatments will be performed.
The study subjects will undergo UltraShape treatments on the flanks area using the U-Sculpt /VDF Transducer.
During the follow-up period visit will be conducted as follow: 4 weeks (4wk FU), 8 weeks (8wk FU) and 16 weeks (16wk FU) post last treatment (Tx.3). Subject's circumference will be measured in the measurements points according to the flanks treated area, circumference reduction will be assessed at each visit. Additionally, a subject questionnaire will be completed in each follow-up visit. Finally, photography will be performed under visible light conditions of the front, right, left and back view. Most of the assessments will occur at each of the visits to the clinic.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ultrashape fat reduction treatment | Experimental | Device: ultrashape Fat reductionall patient undergo non-invasive fat and circumference reduction at the flanks area |
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, between 18 to 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 between 22 to 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
- 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 |
|---|---|---|
| ultrashape Fat reductionAlso: UltrashapeUltrashape Device focused ultrasound to produce localized mechanical motion within fat tissues and cells for the purpose of producing mechanical cellular membrane disruption. It is intended for reduction in abdominal circumference. | Device | ultrashape fat reduction treatment |
Primary outcome
Efficacy flanks fat reduction
Time frame: 4, 8 and 16 weeks post last treatment (Tx.3)
measure by caliper and Ultrasound
6 secondary outcomes
circumference reduction post UltraShape treatments
Time frame: 4, 8 and 16 weeks post last treatment (Tx.3)
fat thickness reduction
Time frame: 4, 8 and 16 weeks post last treatment (Tx.3)
Investigator satisfaction assessment
Time frame: 4, 8 and 16 weeks post last treatment (Tx.3)
Subject satisfaction assessment
Time frame: 4, 8 and 16 weeks post last treatment (Tx.3)
Comfort level
Time frame: day 0, after 2 and 4 weeks
Evaluate the safety for flanks fat reduction
Time frame: up to 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 9207679Adamo C, Mazzocchi M, Rossi A, Scuderi N. Ultrasonic liposculpturing: extrapolations from the analysis of in vivo sonicated adipose tissue. Plast Reconstr Surg. 1997 Jul;100(1):220-6. doi: 10.1097/00006534-199707000-00033.
- Background: PubMed 16453321Goldman A. Submental Nd:Yag laser-assisted liposuction. Lasers Surg Med. 2006 Mar;38(3):181-4. doi: 10.1002/lsm.20270.
- Background: PubMed 14558399Hexsel D, Serra M, Mazzuco R, Dal'Forno T, Zechmeister D. Phosphatidylcholine in the treatment of localized fat. J Drugs Dermatol. 2003 Oct;2(5):511-8.
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.
William P Coleman, MD principal investigator
Coleman Center for Cosmetic Dermatologic Surgery 4425 Conlin Street, Metairie, Louisiana 70006
Michael Gold, MD principal investigator
Gold Skin Care Center, 2000 Richard Jones Road, Suite 220, Nashville, TN 37215 USA
Robert Weiss, MD principal investigator
54 Scot Adams Road, Hunt Valley Baltimore USA
Questions about this trial
What is this clinical trial studying?
A study testing ultrashape Fat reduction in people with Unwanted Flanks Fat, run by Syneron Medical.
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: paused, 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.
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?
Efficacy flanks fat reduction (time frame: 4, 8 and 16 weeks post last treatment (Tx.3)). 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 NCT02465762, which also lists 3 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; AzTrials last refreshed its copy on 31 Oct 2026.