Flanks Fat Reduction vs. ControlNCT02465775
Fat Reduction in the Flanks Area vs. Control
A study testing UltraShape treatment in people with Flanks Fat Reduction vs. Control, run by Syneron Medical at 3 sites in United States.
Trial summary
Prospective, blinded, one arm, baseline-controlled clinical study for the evaluation the performance of the UltraShape treatment for non-invasive fat reduction by compare control and treated flanks. Study subjects will undergo UltraShape treatments on one randomized flank using the U-Sculpt/VDF Transducer. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Flanks Fat Reduction vs. Control
- What is being tested?
- UltraShape treatment
- 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
- Jul 2015to Dec 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).
Show all 11Show fewer
- 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
Show all 19Show fewer
- 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)
- 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.
Trial locations and contacts
3 sites in 1 country.
Robert Weiss, MD contact
United States3 sites, 3 recruiting
- Recruiting
Maryland Laser, Skin, & Vein Institute, LLC
Hunt Valley, Maryland, 21030
Cristi Myers, 410-666-3960, info@mdlsv.com
Robert A Weiss, M.D.
- Recruiting
Coleman Center for Cosmetic Dermatologic Surgery
Metairie, Louisiana, 70006
Karyn Fortier, 504-455-3180, drcolemanresearch@gmail.com
William P Coleman, M.D.
- Recruiting
Gold Skincare
Nashville, Tennessee, 37215
Brynne Thompson, 615-383-9660, BThompson@tnclinicalresearch.com
Michael Gold, MD
About this study
Official title: Clinical Study to Evaluate the Performance of the UltraShape Device for Fat Reduction Treatment in the Flanks Area vs. Control
Prospective, blinded, one arm, baseline-controlled clinical study for the evaluation the performance of the UltraShape treatment for non-invasive fat reduction by compare control and treated flanks.
Study subjects will undergo UltraShape treatments on one randomized flank using the U-Sculpt/VDF Transducer. The second flank will not be treated (control). Both flanks (treated and control) will be compared to baseline, as well as, one to each other
Read the detailed description
This study is a prospective, baseline and blinded controlled, comparison, clinical study showing the performance and safety of the UltraShape treatment for non-invasive fat reduction at the flanks area comparing improvement observed in treated versus control flanks.
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 fat thickness will be measured on both flanks. Three successive bi-weekly (two weeks interval) UltraShape treatments will be performed on one randomized flank, while the second flank will not be treated and served as a control.
The study subjects will undergo UltraShape treatments on one flank using the U-Sculpt /VDF Transducer, the treated flank will remain steady along the study and will be comparing to the baseline and to the controlled flank Three follow-up visits will be conducted as follows: 4 weeks (4wk FU), 8 weeks (8wk FU) and 16 weeks (16wk FU) post last treatment (Tx.3).
Subject's fat thickness will be measured on both flanks in the measurements points using caliper at each visit (at treatment visits, prior to treatment). Ultrasound measurements will be taken at each visit, except for the second treatment visit, on each flank. Investigator satisfaction will be assessed at all FU visits. In addition, subject questionnaires will be completed at each follow-up visit. Photographs of the front, right, left and back view of each flank will be performed under visible light conditions at each study visit.
- Conditions
- Flanks Fat Reduction vs. Control
- Being tested
- UltraShape treatment
- Keywords
- non-invasive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltraShape treatmentDevice
Also called Contour V1
Fat cell destruction is achieved by ultrasound-induced mechanical effects during a very short exposure time.
| Study group | Role | What they receive |
|---|---|---|
| UltraShape treatment in all subjects | Experimental | UltraShape treatment for fat reduction to unilateral flank for all subjects with untreated flank as control. Receives: Device: UltraShape treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of flank fat reduction vs. control
Evaluate the efficacy of UltraShape treatments with the U-sculpt/VDF Transducer for flanks fat reduction as assessed by comparing the change during the study on the treated flank area and compare to the change observed on the un-treated (control) flank
Measured: up to 16 weeks after treatment
Secondary outcomes (5)
Fat thickness reduction on the treated flank
measured by caliper and by Ultrasound device
Measured: 4, 8 and 16 weeks
Investigator satisfaction assessment
5-Point Likert Scale
Measured: 4, 8 and 16 weeks
Subject satisfaction assessment
Subjects will answer the questionnaire
Measured: 4, 8 and 16 weeks
pain assessment
NSR scale
Measured: day 0, 2 weeks and 4 weeks
Safety of flank 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 after treatment
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 startJul 2015
- Primary completionSep 2017 (estimated)
- Study completionDec 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 Flanks Fat Reduction vs. ControlStudies 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, 54 Scot Adams Road, Hunt Valley Baltimore USAWilliam P. Colem, MD, Principal investigator, Coleman Center for Cosmetic Dermatologic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02465775
- Sponsor's protocol ID
- DHF18361
- Status last verified
- Apr 2016
- First submitted
- 1 Jun 2015
- Last updated
- 14 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
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 9415044Gasparotti M. Superficial liposuction: a new application of the technique for aged and flaccid skin. Aesthetic Plast Surg. 1992 Spring;16(2):141-53. doi: 10.1007/BF00450606.
PubMed 1570777
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 Fat Reduction Treatment in the Flanks Area vs. Control
- ClinicalTrials.gov ID
- NCT02465775
- Acronym / sponsor ID
- DHF18361
- Conditions
- Flanks Fat Reduction vs. Control
- Keywords
- non-invasive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Syneron MedicalIndustry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Dec 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 the performance of the UltraShape treatment for non-invasive fat reduction by compare control and treated flanks.
Study subjects will undergo UltraShape treatments on one randomized flank using the U-Sculpt/VDF Transducer. The second flank will not be treated (control). Both flanks (treated and control) will be compared to baseline, as well as, one to each other
Detailed description
This study is a prospective, baseline and blinded controlled, comparison, clinical study showing the performance and safety of the UltraShape treatment for non-invasive fat reduction at the flanks area comparing improvement observed in treated versus control flanks.
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 fat thickness will be measured on both flanks. Three successive bi-weekly (two weeks interval) UltraShape treatments will be performed on one randomized flank, while the second flank will not be treated and served as a control.
The study subjects will undergo UltraShape treatments on one flank using the U-Sculpt /VDF Transducer, the treated flank will remain steady along the study and will be comparing to the baseline and to the controlled flank Three follow-up visits will be conducted as follows: 4 weeks (4wk FU), 8 weeks (8wk FU) and 16 weeks (16wk FU) post last treatment (Tx.3).
Subject's fat thickness will be measured on both flanks in the measurements points using caliper at each visit (at treatment visits, prior to treatment). Ultrasound measurements will be taken at each visit, except for the second treatment visit, on each flank. Investigator satisfaction will be assessed at all FU visits. In addition, subject questionnaires will be completed at each follow-up visit. Photographs of the front, right, left and back view of each flank will be performed under visible light conditions at each study visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UltraShape treatment in all subjects | Experimental | Device: UltraShape treatmentUltraShape treatment for fat reduction to unilateral flank for all subjects with untreated flank as control. |
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 (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 |
|---|---|---|
| UltraShape treatmentAlso: Contour V1Fat cell destruction is achieved by ultrasound-induced mechanical effects during a very short exposure time. | Device | UltraShape treatment in all subjects |
Primary outcome
efficacy of flank fat reduction vs. control
Time frame: up to 16 weeks after treatment
Evaluate the efficacy of UltraShape treatments with the U-sculpt/VDF Transducer for flanks fat reduction as assessed by comparing the change during the study on the treated flank area and compare to the change observed on the un-treated (control) flank
5 secondary outcomes
Fat thickness reduction on the treated flank
Time frame: 4, 8 and 16 weeks
Investigator satisfaction assessment
Time frame: 4, 8 and 16 weeks
Subject satisfaction assessment
Time frame: 4, 8 and 16 weeks
pain assessment
Time frame: day 0, 2 weeks and 4 weeks
Safety of flank fat reduction
Time frame: up to 20 weeks after treatment
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 9415044Arner P. Regional adipocity in man. J Endocrinol. 1997 Nov;155(2):191-2. doi: 10.1677/joe.0.1550191. No abstract available.
- Background: PubMed 1570777Gasparotti M. Superficial liposuction: a new application of the technique for aged and flaccid skin. Aesthetic Plast Surg. 1992 Spring;16(2):141-53. doi: 10.1007/BF00450606.
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
54 Scot Adams Road, Hunt Valley Baltimore USA
William P. Colem, MD principal investigator
Coleman Center for Cosmetic Dermatologic Surgery
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 treatment in people with Flanks Fat Reduction vs. Control, 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?
efficacy of flank fat reduction vs. control (time frame: up to 16 weeks after treatment). 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 NCT02465775, 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.