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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04050033
Recruitment Status : Completed
First Posted : August 8, 2019
Last Update Posted : January 11, 2022
Sponsor:
Information provided by (Responsible Party):
InMode MD Ltd.

Tracking Information
First Submitted Date  ICMJE August 6, 2019
First Posted Date  ICMJE August 8, 2019
Last Update Posted Date January 11, 2022
Actual Study Start Date  ICMJE June 19, 2019
Actual Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2019)
  • Number of participants with Change in Skin Appearance [ Time Frame: 1 month, 3 month, 6 months ]
    Picture evaluation by blinded investigators.
  • 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
  • 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).
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 6, 2019)
  • Evaluate Skin Improvement [ Time Frame: 1 month, 3 month, 6 months ]
    Picture evaluation by blinded investigators.
    • Success is defined by correct identification of the pre and post treatment photos as demonstrated in at least 70% or greater of patients completed the treatment at 1 month, 3 months and 6 months post treatment.
    • At least 2 out of 3 blinded evaluators should agree on the assessment.
  • Evaluate Improvement in skin appearance using 3D Photographic analysis [ Time Frame: 1 month, 3 month, 6 months ]
    3D Photographic analysis will be conducted using QuantifiCare System
  • 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).
  • Evaluate improvement in skin tightening 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2019)
  • 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
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evoke Radiofrequency Device for Improvement of Skin Appearance
Official Title  ICMJE Clinical Study to Evaluate the Performance of Evoke Radiofrequency Device for Improvement of Skin Appearance
Brief Summary The aim of the study is to evaluate the safety, efficacy, patient comfort and patient satisfaction after Evoke treatment
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Improvement of Skin Appearance
Intervention  ICMJE Device: Evoke Device
Subjects will undergo treatment with Evoke Device
Study Arms  ICMJE Experimental: Treatment Arm
Enrolled subjects will undergo up to 3 successive bi-weekly (every 2 weeks) treatments (Tx.1, Tx.2 and Tx.3).
Intervention: Device: Evoke Device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 23, 2019)
30
Original Estimated Enrollment  ICMJE
 (submitted: August 6, 2019)
20
Actual Study Completion Date  ICMJE December 30, 2021
Actual Primary Completion Date December 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04050033
Other Study ID Numbers  ICMJE DO608679A
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party InMode MD Ltd.
Study Sponsor  ICMJE InMode MD Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account InMode MD Ltd.
Verification Date January 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP