Evoke Radiofrequency Device for Improvement of Skin Appearance

Clinical Study to Evaluate the Performance of Evoke Radiofrequency Device for Improvement of Skin Appearance

The aim of the study is to evaluate the safety, efficacy, patient comfort and patient satisfaction after Evoke treatment

Study Overview

• Status: Completed
• Conditions: Improvement of Skin Appearance
• Intervention / Treatment: Device: Evoke Device

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nevada
    • Reno, Nevada, United States, 89511
      • Avance Plastic Surgery Institute
  • New York
    • New York, New York, United States, 10003
      • Union Square Laser Dermatology
    • New York, New York, United States, 10019
      • BodySculpt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• - Signed informed consent to participate in the study.
• Female and male subjects, 35 - 75 years of age at the time of enrolment
• 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).
• In addition, negative urine pregnancy test as tested before each treatment and at the last visit for women with childbearing potential (e.g. not menopause).
• General good health confirmed by medical history and skin examination of the treated area.
• Willing to have photographs and images taken of the treated areas to be used de-identified in evaluations, publications and presentations.
• The patients should be willing to comply with the study procedure and schedule, including the follow up visit, and will refrain from using any other aesthetic treatment methods for the last 6 months and during the entire study period.

Exclusion Criteria:

• - Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
• Permanent implant in the treated area such as metal plates and screws, silicone implants or an injected chemical substance, unless deep enough in the periostal plane.
• Current or history of skin cancer, or current condition of any other type of cancer, or premalignant moles.
• Severe concurrent conditions, such as cardiac disorders, epilepsy, uncontrolled hypertension, and liver or kidney diseases.
• Pregnancy and nursing.
• Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications.
• Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regimen.
• Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction.
• Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
• History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin.
• History of bleeding coagulopathies or use of anticoagulants in the last 10 days.
• Any surgery in treated area within 3 months prior to treatment.
• Six months delay is required if other recent treatments like light, CO2 laser or RF were performed on the same area.
• Use of Isotretinoin (Accutane®) within 6 months prior to treatment.
• As per the practitioner's discretion, refrain from treating any condition that might make it unsafe for the patient

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treatment Arm; Enrolled subjects will undergo up to 3 successive bi-weekly (every 2 weeks) treatments (Tx.1, Tx.2 and Tx.3).	Device: Evoke Device; Subjects will undergo treatment with Evoke Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with Change in Skin Appearance	Picture evaluation by blinded investigators.	1 month, 3 month, 6 months
Evaluate rate of Change in Skin Appearance using 3D Photographic analysis	3D Photographic analysis will be conducted using QuantifiCare System	1 month, 3 month, 6 months
Evaluate changes in skin using VivoSight Optical Coherence Tomography (OCT) software	Non-invasive in vivo skin imaging will be taken with the VivoSight Optical Coherence Tomography (OCT).	1 month, 3 month, 6 months
Evaluate changes in skin appearance comparing photographs using Mechanical Turk (MTurk). The pictures will be sent through the system and evaluated by crowd workers.	The pictures will be sent through the system and evaluated by crowd workers.	1 month, 3 month, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate Investigator assessment of the skin appearance improvement	Investigator assessment of the skin appearance improvement comparing pre and post treatment using 0 - 4 -points Likert scale at 1 month, 3 months and 6 months follow up visits: • 4 = Significantly marked improvement; 3 = Marked improvement; 2 = Moderate improvement; 1 = Slight improvement; 0 = No difference	1 Month, 3 Months, 6 Months
Evaluate Subject assessment of improvement and satisfaction	Improvement assessment will be performed independently by the subject himself 4 points Likert scale questionnaire (Global Aesthetic Improvement Scale), as follows: • 4 = Significantly marked improvement; 3 = Marked improvement; 2 = Moderate improvement; 1 = Slight improvement; 0 = No difference. Subject assessment of satisfaction will be filled out by subjects using a 5-points Likert scale, as follows: • +2 = Very satisfied; +1 = Satisfied; 0 = Indifferent; -1 = Disappointed; -2 = Very disappointed.	1 Month, 3 Months, 6 Months
Evaluate histological changes to treatment area skin	Positive changes in histologic evaluation: up to 5 subjects will undergo biopsies of the treated area for histology at baseline and at 3M follow-up visit. Histological sections will be stained using elastin, H&E and other collagen specific stains.	3 Months

Collaborators and Investigators

• Sponsor: InMode MD Ltd.
• Investigators: Principal Investigator: Erez Dayan, MD, Avance Plastic Surgery Institute 5570 Longley Lane, Suite A Reno, NV 89511; Principal Investigator: Christopher Chia, MD, BodySculpt 128 Central Park S New York, NY 10019

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 19, 2019
• Primary Completion (ACTUAL): December 30, 2021
• Study Completion (ACTUAL): December 30, 2021

Study Registration Dates

• First Submitted: August 6, 2019
• First Submitted That Met QC Criteria: August 6, 2019
• First Posted (ACTUAL): August 8, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 11, 2022
• Last Update Submitted That Met QC Criteria: January 10, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: DO608679A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No