Safety and Efficacy of Combined EMS and RF Treatments

Baseline Controlled Study to Evaluate the Safety and Efficacy of Combined EMS and RF Treatments for Non-Invasive Circumference Reduction and Skin Tightening

The objective of this trial is to evaluate the safety and efficacy of the Evolve device utilizing the Ti10 and Tone applicators for abdominal non-invasive circumference reduction and skin tightening

Study Overview

• Status: Completed
• Conditions: Non-invasive Circumference Reduction
• Intervention / Treatment: Device: Treatment with Evolve System

• Study Type: Interventional
• Enrollment (Actual): 18
• 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, 10019
      • BodySculpt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• - Signed informed consent to participate in the study.
• Female and male subjects,18 - 65 years of age at the time of enrolment
• BMI≤ 30
• 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 enrolment (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 metallic or electronic implant anywhere in the body.
• Permanent implant in the treated area such as metal plates, screws and metal piercing, silicone implants or an injected chemical substance, unless deep enough in the periosteal plane.
• Intra-dermal or superficial sub-dermal areas that have been injected with HA/collagen/fat injections or other augmentation methods with bio-material during last 6 months.
• Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles.
• Severe concurrent conditions, such as cardiac disorders, sensory disturbances, epilepsy, uncontrolled hypertension, and liver or kidney diseases.
• Pregnancy and nursing.
• Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, autoimmune disorders 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 and hormonal virilization.
• 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 surgical procedure in the treatment area within the last 6 months or before complete healing.
• Having received treatment with light, laser, RF, or other devices in the treated area within 3 months, or before complete healing.
• Use of Isotretinoin (Accutane®) within 6 months prior to treatment.
• As per the practitioner's discretion, refrain from treating any condition which might make it unsafe for the patient.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm; Eligible subjects will receive up to 3 treatments (2-week interval) with the Evolve device utilizing the Ti10 and Tone applicators according to the study protocol.	Device: Treatment with Evolve System; EMS and RF Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in circumference reduction	statistical difference in circumference reduction between Control (baseline measurement) and three points of follow-up measurement: 4 weeks (1Month) 12 weeks (3Month) and 24 weeks (6 months) following the last Tx session.	1 month, 3 month, 6 months
Change in skin appearance	Improvement in skin appearance comparing pre and at 1, 3 months and 6 months post last treatment photographs (as assessed 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.	1 month, 3 month, 6 months
Change in abdomen area appearance assessed by 3D Photographic analysis	3D Photographic analysis will be conducted using QuantifiCare System at follow up visits and compared to the baseline.	1 month, 3 month, 6 months
Change in abdomen area appearance assessed by Investigator	- Investigator assessment of the skin appearance comparing pre and post treatment using 0 - 4 -points Likert scale at follow up visits: 4 = Significantly marked improvement; 3 = Marked improvement; 2 = Moderate improvement; 1 = Slight improvement; 0 = No difference	1 month, 3 month, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject Improvement assessment	Improvement assessment will be performed independently by the subject himself using 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.	1 Month, 3 Months, 6 Months
Subject satisfaction assessment	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
Subject assessment of comfort	Subject assessment of comfort will be filled out by subjects using a 5-point Likert scale, as follows: +2 = Very comfortable; +1 = Comfortable; 0 = Indifferent; -1 = uncomfortable; -2 = Pain.	1 month, 3 months, 6 months

Collaborators and Investigators

• Sponsor: InMode MD Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2019
• Primary Completion (Actual): May 19, 2021
• Study Completion (Actual): May 19, 2021

Study Registration Dates

• First Submitted: August 6, 2019
• First Submitted That Met QC Criteria: October 10, 2019
• First Posted (Actual): October 11, 2019

Study Record Updates

• Last Update Posted (Actual): August 25, 2021
• Last Update Submitted That Met QC Criteria: August 24, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: DO608715A

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