Evoke Radiofrequency Device for Improvement of Skin Appearance

NCT ID: NCT04050033

Last Updated: 2022-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-19
• Study Completion Date: 2021-12-30

Brief Summary

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

Conditions

Improvement of Skin Appearance

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Arm

Enrolled subjects will undergo up to 3 successive bi-weekly (every 2 weeks) treatments (Tx.1, Tx.2 and Tx.3).

Group Type: EXPERIMENTAL

Evoke Device

Intervention Type: DEVICE

Subjects will undergo treatment with Evoke Device

Interventions

Evoke Device

Subjects will undergo treatment with Evoke Device

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

InMode MD Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erez Dayan, MD

Role: PRINCIPAL_INVESTIGATOR

Avance Plastic Surgery Institute 5570 Longley Lane, Suite A Reno, NV 89511

Christopher Chia, MD

Role: PRINCIPAL_INVESTIGATOR

BodySculpt 128 Central Park S New York, NY 10019

Locations

Avance Plastic Surgery Institute

Reno, Nevada, United States

Union Square Laser Dermatology

New York, New York, United States

BodySculpt

New York, New York, United States

Countries

United States

Other Identifiers

DO608679A

Identifier Type: -

Identifier Source: org_study_id