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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VelaShape device | Device | Modified VelaShape radiofrequency device for non invasive fat reduction treatment. |
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| Measure | Description | Time Frame |
|---|---|---|
| histology following VelaShape treatment | Evaluate abdominal fat reduction post VelaShape treatment vs.control | day 10 up to 90 days |
| Histology following Contour I V3 treatment | Evaluate Abdominal fat reduction post Contour I V3 treatment vs. control | day 10 up to 90 days |
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Inclusion Criteria:
Exclusion Criteria:
A subject is not eligible for participation in this study if he/she meets any of the following exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dean Ad-El, M.D | Contact | +972-3-9376366 | deana@clalit.org.il |
| Name | Affiliation | Role |
|---|---|---|
| Dr. Dean Ad-El, M.D | Plastic surgery department , Blinson - Rabin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rabin Medical Center - Beilinson Hospital | Recruiting | Petah Tikva | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9207679 | Background | 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. |
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| Contour I V3 device | Device | Contour I V3 device are non invasive for fat reduction. |
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