Safety and Efficacy of Combined EMS and RF Treatments

NCT ID: NCT04124419

Last Updated: 2021-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-19
• Study Completion Date: 2021-05-19

Brief Summary

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

Conditions

Non-invasive Circumference Reduction

Study Design

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

Study Groups

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.

Group Type: EXPERIMENTAL

Treatment with Evolve System

Intervention Type: DEVICE

EMS and RF Treatment

Interventions

Treatment with Evolve System

EMS and RF Treatment

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

InMode MD Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Avance Plastic Surgery Institute

Reno, Nevada, United States

BodySculpt

New York, New York, United States

Countries

United States

Other Identifiers

DO608715A

Identifier Type: -

Identifier Source: org_study_id