VelaShape and Contour I V3 for Abdominal Fat Reduction vs. Control

April 6, 2017 updated by: Syneron Medical

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Petah Tikva, Israel
        • Recruiting
        • Rabin Medical Center - Beilinson Hospital
        • Contact:
          • Dean Ad-El, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Signed informed consent to participate in the study.
  2. Scheduled date for surgery (abdominoplasty).
  3. Agree to provide samples for histology from the abdominoplasty.
  4. Female and male subjects, between 18 to 60 years of age at the time of enrollment
  5. Fitzpatrick Skin Type I to VI.
  6. For Contour I V3 treatment only: Abdominal fat thickness of at least 1.5 cm (measured by calibrated caliper).
  7. 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).
  8. General good health confirmed by medical history and skin examination of the treated area.
  9. Willing to follow the treatment and to provide histology samples during the surgery from the intended to be harvested areas.
  10. Willingness to refrain from a change in diet/ exercise/medication regimen for the entire course of the study.
  11. Willing to have photographs and images taken of the treated areas to be used (with de-identification) in evaluations, publications and presentations

Exclusion Criteria:

A subject is not eligible for participation in this study if he/she meets any of the following exclusion criteria:

  1. History of hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker/defibrillator, or abdominal aortic aneurism
  2. Not intended to undergo surgery (abdominoplasty)
  3. Current hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease
  4. 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
  5. Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator
  6. Having a permanent implant in the treated area, such as metal plates, or an injected chemical substance such as silicone
  7. Having undergone any other surgery in the treatment area within 12 months of treatment or during the study, including liposuction
  8. Previous body contouring procedures in the treatment area within 12 months
  9. History of skin disease in the treatment area, known tendency to form keloids or poor wound healing Known photosensitivity
  10. 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
  11. 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
  12. Very poor skin quality (i.e., severe laxity)
  13. Abdominal wall diastasis or hernia on physical examination
  14. Abnormal kidney, liver or coagulation functions, abnormal lipid profile or blood count within the last 3 months
  15. Any acute or chronic condition which, in the opinion of the investigator, could interfere with the conduct of the study
  16. Unstable weight within the last 6 months (i.e., more than ± 3% weight change in the prior 6 months)
  17. Participation in another clinical study within the last 6 months.
  18. As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment with VelaShape device

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
Device: VelaShape device
Modified VelaShape radiofrequency device for non invasive fat reduction treatment.
Experimental: Treatment with Contour I V3 device

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
Device: Contour I V3 device
Contour I V3 device are non invasive for fat reduction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
histology following VelaShape treatment
Time Frame: day 10 up to 90 days
Evaluate abdominal fat reduction post VelaShape treatment vs.control
day 10 up to 90 days
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
day 10 up to 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Syneron Medical

Investigators

  • Principal Investigator: Dr. Dean Ad-El, M.D, Plastic surgery department , Blinson - Rabin Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2016

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

September 10, 2015

First Submitted That Met QC Criteria

September 16, 2015

First Posted (Estimate)

September 17, 2015

Study Record Updates

Last Update Posted (Actual)

April 10, 2017

Last Update Submitted That Met QC Criteria

April 6, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DHF18521

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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