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Safety and Efficacy of Combined EMS and RF Treatments | Clinical Trials | Clareo Health

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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

NCT04124419•InMode MD Ltd.

View on ClinicalTrials.gov

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

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

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.
+6 more criteria

Locations (2)

Avance Plastic Surgery Institute

Reno, Nevada, United States

BodySculpt

New York, New York, United States

Key Dates

Start Date

July 19, 2019

Primary Completion Date

May 19, 2021

Completion Date

May 19, 2021

Last Updated

February 27, 2026

Enrollment

ACTUAL participants

Conditions

Non-invasive Circumference Reduction

Interventions

Treatment with Evolve System

DEVICE