Safety and Efficacy of Combined EMS and RF Treatments

NCT04124419 | Completed Results FDA Device

• 1 other identifier: DO608715A
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Change in Circumference Reduction

  Change in circumference measured in centimeters from baseline to 6 months following the last treatment session. Circumference was measured using a standard measuring tape. Negative values indicate a reduction in circumference.

  Baseline to 6 months following last treatment session

Secondary Outcomes (3)

• Change in Abdomen Area Appearance Assessed by Investigator

  6 month

• Subject Improvement Assessment

  6 Months

• Subject Satisfaction Assessment

  6 months

Study Arms (1)

Treatment Arm

EXPERIMENTAL

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

Interventions

Treatment with Evolve System DEVICE

EMS and RF Treatment

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• InMode MD Ltd.: lead

Study Sites (2)

Avance Plastic Surgery Institute

Reno, Nevada, 89511, United States

Location

BodySculpt

New York, New York, 10019, United States

Location

MeSH Terms

Interventions

Therapeutics

Results Point of Contact

• Title: Maria Shusterman
• Organization: Inmode

Maria.shusterman@inmodemd.com

9492396522

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: October 11, 2019
• Study Start: July 19, 2019
• Primary Completion: May 19, 2021
• Study Completion: May 19, 2021
• Last Updated: February 27, 2026
• Results First Posted: February 27, 2026

Record last verified: 2026-02

Locations

US (2)