Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evoke Radiofrequency Device for Improvement of Skin Appearance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04050033
Recruitment Status : Recruiting
First Posted : August 8, 2019
Last Update Posted : August 9, 2019
Sponsor:
Information provided by (Responsible Party):
InMode MD Ltd.

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

Condition or disease Intervention/treatment Phase
Improvement of Skin Appearance Device: Evoke Device Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study to Evaluate the Performance of Evoke Radiofrequency Device for Improvement of Skin Appearance
Actual Study Start Date : June 19, 2019
Estimated Primary Completion Date : July 19, 2020
Estimated Study Completion Date : August 19, 2020

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




Primary Outcome Measures :
  1. Number of participants with Change in Skin Appearance [ Time Frame: 1 month, 3 month, 6 months ]
    Picture evaluation by blinded investigators.

  2. Evaluate rate of Change in Skin Appearance using 3D Photographic analysis [ Time Frame: 1 month, 3 month, 6 months ]
    3D Photographic analysis will be conducted using QuantifiCare System

  3. Evaluate changes in skin using VivoSight Optical Coherence Tomography (OCT) software [ Time Frame: 1 month, 3 month, 6 months ]
    Non-invasive in vivo skin imaging will be taken with the VivoSight Optical Coherence Tomography (OCT).

  4. Evaluate changes in skin appearance comparing photographs using Mechanical Turk (MTurk). The pictures will be sent through the system and evaluated by crowd workers. [ Time Frame: 1 month, 3 month, 6 months ]
    The pictures will be sent through the system and evaluated by crowd workers.


Secondary Outcome Measures :
  1. Evaluate Investigator assessment of the skin appearance improvement [ Time Frame: 1 Month, 3 Months, 6 Months ]

    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


  2. Evaluate Subject assessment of improvement and satisfaction [ Time Frame: 1 Month, 3 Months, 6 Months ]

    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.


  3. Evaluate histological changes to treatment area skin [ Time Frame: 3 Months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04050033


Contacts
Layout table for location contacts
Contact: Maureen Abdulla 949.305.0106 maureen.abdulla@inmodemd.com
Contact: Maria Shusterman 4164589001 marias@inmodemd.com

Locations
Layout table for location information
United States, Nevada
Avance Plastic Surgery Institute Recruiting
Reno, Nevada, United States, 89511
Contact: Erez Dayan, MD    775-800-4444      
United States, New York
BodySculpt Recruiting
New York, New York, United States, 10019
Contact: Christopher Chia, MD    212-265-2724      
Sponsors and Collaborators
InMode MD Ltd.
Investigators
Layout table for investigator information
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

Layout table for additonal information
Responsible Party: InMode MD Ltd.
ClinicalTrials.gov Identifier: NCT04050033     History of Changes
Other Study ID Numbers: DO608679A
First Posted: August 8, 2019    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No