Clinical trial NCT04124419: Safety and Efficacy of Combined EMS and RF Treatments
Official title: Baseline Controlled Study to Evaluate the Safety and Efficacy of Combined EMS and RF Treatments for Non-Invasive Circumference Reduction and Skin Tightening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-invasive Circumference Reduction
Lead sponsor: InMode MD Ltd.
Sponsor class: INDUSTRY
First posted: 2019-10-11
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Change in circumference reduction
timeFrame: 1 month, 3 month, 6 months
measure: Change in skin appearance
timeFrame: 1 month, 3 month, 6 months
measure: Change in abdomen area appearance assessed by 3D Photographic analysis
timeFrame: 1 month, 3 month, 6 months
measure: Change in abdomen area appearance assessed by Investigator
timeFrame: 1 month, 3 month, 6 months
Secondary outcomes:
measure: Subject Improvement assessment
timeFrame: 1 Month, 3 Months, 6 Months
measure: Subject satisfaction assessment
timeFrame: 1 month, 3 months, 6 months
measure: Subject assessment of comfort
timeFrame: 1 month, 3 months, 6 months
Other outcomes:
Locations:
city: Reno
country: United States
facility: Avance Plastic Surgery Institute
state: Nevada
city: New York
country: United States
facility: BodySculpt
state: New York
Study officials:
References: