Unwanted Abdomen FatNCT02553278
VelaShape and Contour I V3 for Abdominal Fat Reduction vs. Control
A study testing VelaShape device and Contour I V3 device in people with Unwanted Abdomen Fat, run by Syneron Medical at 1 site in Israel.
Trial summary
Prospective, 2-arm, clinical study for the evaluation of the VelaShape device and Contour I V3 device for non-invasive fat reduction vs. control. All study subjects, who are scheduled for abdominoplasty, will undergo one treatment with VelaShape or Contour I V3 device. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Unwanted Abdomen Fat
- What is being tested?
- VelaShape device and Contour I V3 device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIsrael
- Study dates
- 10 Jan 2016to 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.
- Scheduled date for surgery (abdominoplasty).
- Agree to provide samples for histology from the abdominoplasty.
- Female and male subjects, between 18 to 60 years of age at the time of enrollment
- Fitzpatrick Skin Type I to VI.
- For Contour I V3 treatment only: Abdominal fat thickness of at least 1.5 cm (measured by calibrated caliper).
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- Female subjects 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).
- General good health confirmed by medical history and skin examination of the treated area.
- Willing to follow the treatment and to provide histology samples during the surgery from the intended to be harvested areas.
- 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 (with de-identification) 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, or abdominal aortic aneurism
- Not intended to undergo surgery (abdominoplasty)
- 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
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- 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 treatment area within 12 months of treatment or during the study, including liposuction
- 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 Known photosensitivity
- Suffering from significant skin conditions in the treatment area 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
- 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., more than ± 3% weight change in the prior 6 months)
- 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
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rabin Medical Center - Beilinson Hospital
Petah Tikva
Dean Ad-El, M.D.
About this study
Official title: Clinical Study to Evaluate the Performances of Modified VelaShape and the Performance of Contour I V3 Devices for Abdominal Fat Reduction vs. Control
Prospective, 2-arm, clinical study for the evaluation of the VelaShape device and Contour I V3 device for non-invasive fat reduction vs. control.
All study subjects, who are scheduled for abdominoplasty, will undergo one treatment with VelaShape or Contour I V3 device.
Each arm will be treated with a different device:
Arm 1: subject will treated with VelaShape device Arm 2: subject will treated with Contour I V3 device
Read the detailed description
Eligible subjects will undergo one treatment on one abdominal subarea. Another abdominal subarea will remain without treatment and will serve as a control. Biopsies from treated and untreated areas will be harvested during abdominoplasty and cultured.. Treatment with VelaShape will be performed to arm 1, and treatment with Contour I V3 will be performed to arm 2, according to the study protocol.
Each arm will be divided into 6 sub-groups, according to the following time interval between VelaShape or UltraShape treatment to surgery:
Sub-group 1: Surgery immediately after treatment Sub-group 2: Surgery 10 days after treatment Sub-group 3: Surgery 20 days after treatment Sub-group 4: Surgery 30 days after treatment Sub-group 5: Surgery 60 days after treatment Sub-group 6: Surgery 90 days after treatment Each Sub-group contains up to 2 subjects.
- Conditions
- Unwanted Abdomen Fat
- Being tested
- VelaShape device, Contour I V3 device
- Keywords
- abdominoplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VelaShape deviceDevice
Modified VelaShape radiofrequency device for non invasive fat reduction treatment.
Contour I V3 deviceDevice
Contour I V3 device are non invasive for fat reduction.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with VelaShape device | Experimental | One treatment will be performed by the VelaShape device on one randomized abdominal subarea, while the other abdominal subarea will not be treated and will serve as a control. Biopsies will be harvested during abdominoplasty and cultured. Two histology samples, for each subject, will be obtained during the abdominoplasty surgery, The arm is divided to 6 sub-groups, where each Sub-group contains up to 2 subjects as follows:
Sub-group 1: Surgery immediately after treatment Sub-group 2: Surgery 5 days after treatment Sub-group 3: Surgery 10 days after treatment Sub-group 4: Surgery 20 days after treatment Sub-group 5: Surgery 30 days after treatment Sub-group 6: Surgery 60 days after treatment Sub-group 7: Surgery 90 days after treatment Receives: Device: VelaShape device |
| Treatment with Contour I V3 device | Experimental | One treatment will be performed by Contour I V3 device on one randomized abdominal subarea, while the other abdominal subarea will not be treated and will serve as a control. Biopsies from treated and untreated subareas will be harvested during abdominoplasty and cultured. Two histology samples, for each subject, will be obtained during the abdominoplasty surgery. The arm is divided to 6 sub-groups, where each Sub-group contains up to 2 subjects as follows:
Sub-group 1: Surgery immediately after treatment Sub-group 2: Surgery 10 days after treatment Sub-group 3: Surgery 20 days after treatment Sub-group 4: Surgery 30 days after treatment Sub-group 5: Surgery 60 days after treatment Sub-group 6: Surgery 90 days after treatment Receives: Device: Contour I V3 device |
What is being measured
The primary outcome is the main question the study is designed to answer.
histology following VelaShape treatment
Evaluate abdominal fat reduction post VelaShape treatment vs.control
Measured: day 10 up to 90 days
Histology following Contour I V3 treatment
Evaluate Abdominal fat reduction post Contour I V3 treatment vs. control
Measured: day 10 up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study start10 Jan 2016
- Primary completionOct 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 (1)Papers the sponsor has linked to this study.
- Other trials for Unwanted Abdomen 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Syneron Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Dean Ad-El, M.D, Principal investigator, Plastic surgery department , Blinson - Rabin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02553278
- Sponsor's protocol ID
- DHF18521
- Status last verified
- Apr 2017
- First submitted
- 10 Sep 2015
- Last updated
- 10 Apr 2017
- 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 9207679
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Performances of Modified VelaShape and the Performance of Contour I V3 Devices for Abdominal Fat Reduction vs. Control
- ClinicalTrials.gov ID
- NCT02553278
- Acronym / sponsor ID
- DHF18521
- Conditions
- Unwanted Abdomen Fat
- Keywords
- abdominoplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Syneron MedicalIndustry (pharma, biotech, devices)
- Study start
- 10 Jan 2016 (actual)
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 17 Sep 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, 2-arm, clinical study for the evaluation of the VelaShape device and Contour I V3 device for non-invasive fat reduction vs. control.
All study subjects, who are scheduled for abdominoplasty, will undergo one treatment with VelaShape or Contour I V3 device.
Each arm will be treated with a different device:
Arm 1: subject will treated with VelaShape device Arm 2: subject will treated with Contour I V3 device
Detailed description
Eligible subjects will undergo one treatment on one abdominal subarea. Another abdominal subarea will remain without treatment and will serve as a control. Biopsies from treated and untreated areas will be harvested during abdominoplasty and cultured.. Treatment with VelaShape will be performed to arm 1, and treatment with Contour I V3 will be performed to arm 2, according to the study protocol.
Each arm will be divided into 6 sub-groups, according to the following time interval between VelaShape or UltraShape treatment to surgery:
Sub-group 1: Surgery immediately after treatment Sub-group 2: Surgery 10 days after treatment Sub-group 3: Surgery 20 days after treatment Sub-group 4: Surgery 30 days after treatment Sub-group 5: Surgery 60 days after treatment Sub-group 6: Surgery 90 days after treatment Each Sub-group contains up to 2 subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment with VelaShape device | Experimental | Device: VelaShape deviceOne treatment will be performed by the VelaShape device on one randomized abdominal subarea, while the other abdominal subarea will not be treated and will serve as a control. Biopsies will be harvested during abdominoplasty and cultured. Two histology samples, for each subject, will be obtained during the abdominoplasty surgery, The arm is divided to 6 sub-groups, where each Sub-group contains up to 2 subjects as follows: Sub-group 1: Surgery immediately after treatment Sub-group 2: Surgery 5 days after treatment Sub-group 3: Surgery 10 days after treatment Sub-group 4: Surgery 20 days after treatment Sub-group 5: Surgery 30 days after treatment Sub-group 6: Surgery 60 days after treatment Sub-group 7: Surgery 90 days after treatment |
| Treatment with Contour I V3 device | Experimental | Device: Contour I V3 deviceOne treatment will be performed by Contour I V3 device on one randomized abdominal subarea, while the other abdominal subarea will not be treated and will serve as a control. Biopsies from treated and untreated subareas will be harvested during abdominoplasty and cultured. Two histology samples, for each subject, will be obtained during the abdominoplasty surgery. The arm is divided to 6 sub-groups, where each Sub-group contains up to 2 subjects as follows: Sub-group 1: Surgery immediately after treatment Sub-group 2: Surgery 10 days after treatment Sub-group 3: Surgery 20 days after treatment Sub-group 4: Surgery 30 days after treatment Sub-group 5: Surgery 60 days after treatment Sub-group 6: Surgery 90 days after treatment |
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.
- Scheduled date for surgery (abdominoplasty).
- Agree to provide samples for histology from the abdominoplasty.
- Female and male subjects, between 18 to 60 years of age at the time of enrollment
- Fitzpatrick Skin Type I to VI.
Key exclusion criteria (19 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, or abdominal aortic aneurism
- Not intended to undergo surgery (abdominoplasty)
- 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
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 |
|---|---|---|
| VelaShape deviceModified VelaShape radiofrequency device for non invasive fat reduction treatment. | Device | Treatment with VelaShape device |
| Contour I V3 deviceContour I V3 device are non invasive for fat reduction. | Device | Treatment with Contour I V3 device |
Primary outcome
histology following VelaShape treatment
Time frame: day 10 up to 90 days
Evaluate abdominal fat reduction post VelaShape treatment vs.control
Histology following Contour I V3 treatment
Time frame: day 10 up to 90 days
Evaluate Abdominal fat reduction post Contour I V3 treatment vs. control
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
- 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.
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.
Dr. Dean Ad-El, M.D principal investigator
Plastic surgery department , Blinson - Rabin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VelaShape device and Contour I V3 device in people with Unwanted Abdomen 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 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 10 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Dean Ad-El, M.D (+972-3-9376366, deana@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
histology following VelaShape treatment (time frame: day 10 up to 90 days). 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?
On the ClinicalTrials.gov record for NCT02553278, 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 10 Apr 2017.