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

NCT02553278 | Unknown

• 1 other identifier: DHF18521
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Unwanted Abdomen Fat

Keywords

abdominoplasty

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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

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

Device: Contour I V3 device

Interventions

VelaShape device DEVICE

Modified VelaShape radiofrequency device for non invasive fat reduction treatment.

Treatment with VelaShape device

Contour I V3 device DEVICE

Contour I V3 device are non invasive for fat reduction.

Treatment with Contour I V3 device

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Syneron Medical: lead

Study Sites (1)

Rabin Medical Center - Beilinson Hospital

Petah Tikva, Israel

RECRUITING

Related Publications (1)

• 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.

  PMID: 9207679 BACKGROUND

Study Officials

• Dr. Dean Ad-El, M.D

  Plastic surgery department , Blinson - Rabin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Dean Ad-El, M.D

CONTACT

+972-3-9376366; deana@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2015
• First Posted: September 17, 2015
• Study Start: January 10, 2016
• Primary Completion: October 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 10, 2017

Record last verified: 2017-04

Locations

IL (1)