VelaShape III Device in Comparison to Cryolipolysis for Circumferential Reduction

NCT02143960 | Completed

• 1 other identifier: DC85471
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the clinical performance of the VelaShape III device with CoolSculpt for reduction of the waist, love handles and flanks.

Conditions

Abdominal Fat

Keywords

Syneron; Velashape; ELOS; Zeltiq; Cryolipolysis

Outcome Measures

Primary Outcomes (1)

• A blinded rating of the treatment area

  Improvement scores of photographs for the treatment side with the VelaShape III device versus the side treated with CoolSculpt will be blindly evaluated by independent reviewer at baseline and at 3 month post treatment time-point.

  3 month post treatment

Secondary Outcomes (1)

• A blinded rating of the treatment area

  1 week, 1 month and 6 months post treatment

Other Outcomes (3)

• Subject Improvement and Satisfaction Scores

  1 week, 1 month, 3 month and 6 month post treatment

• Investigator Improvement and Satisfaction Scores

  1 week, 1 month, 3 month and 6 month post treatment

• Side Effects and Adverse Events

  Study duration

Study Arms (2)

Velashape III device

ACTIVE COMPARATOR

Controlled infrared (IR) light and conducted bipolar radiofrequency (RF) energies with mechanical manipulation

Device: VelaShape III

Noninvasive Cryolipolysis Device

ACTIVE COMPARATOR

A noninvasive device that reduces fat by freezing fat cells

Device: CoolSculpt

Interventions

VelaShape III DEVICE

Subjects will receive one treatment to their entire waist / love-handle/ flanks area in a split-waist fashion, so that one side is treated with one device and the other side is treated with the other device. The treatment session will include: one side (right or left) treated with the VelaShape III device and the other side (left or right, respectively) with the CoolSculpt device. The subject will be randomized to one of 2 treatment groups, one will receive treatment to the left side with the VelaShape II and the right side will receive treatment with the CoolSculpt. The other group will receive treatment to right side with the VelaShape II and the left side will receive treatment with the CoolSculpt.

Also known as: Vela

Velashape III device

CoolSculpt DEVICE

Noninvasive Cryolipolysis

Also known as: Zeltiq

Noninvasive Cryolipolysis Device

Eligibility Criteria

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

You may qualify if:

• Informed consent process completed and subject completed consent.
• Fitzpatrick Skin Type I to VI
• Having excess fat deposits bilaterally in the waist / love-handle / flank areas.
• BMI score is greater than 18.5 and less than 29.9 - normal to overweight, but not obese.
• 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.
• If female, not pregnant, lactating and 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).
• Willing to have photographs and images taken of the treated areas to be used de-identified in evaluations, publications and presentations.

You may not qualify if:

• Subjects with history of excessive weight fluctuation or expect to gain/lose more than 5 pounds) during the study time frame.
• Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.
• 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.
• Known photosensitivity.
• Having received treatment with laser, RF or other devices in the treated areas within 6 months of treatment or during the study.
• Having undergone any other surgery in the treated areas within 12 months of treatment or during the study, including liposuction.
• 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.
• Suffering from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), lupus, porphyria, or pertinent neurological disorders.
• History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
• Suffering from hormonal imbalance which may affect weight as per the Investigator's discretion.
• History of significant lymphatic drainage problems or impaired circulation in the area to be treated.
• 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.
• History of keloid scarring, abnormal wound healing and / or prone to bruising.
• History of epidermal or dermal disorders (particularly if involving collagen or microvascularity).

Sponsors & Collaborators

• Syneron Medical: lead

Study Sites (1)

Coleman Center for Cosmetic Dermatologic Surgery

Metairie, Louisiana, 70006, United States

Location

Study Officials

• Shlomit Mann

  Syneron Medical Ltd.

  STUDY DIRECTOR

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: May 19, 2014
• First Posted: May 21, 2014
• Study Start: September 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: December 2, 2014

Record last verified: 2014-11

Locations

US (1)