Non-invasive Circumference Reduction
Conditions
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
Interventions
DEVICETreatment with Evolve System
EMS and RF Treatment
Sponsors
InMode MD Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Circumference Reduction | Baseline to 6 months following last treatment session | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Abdomen Area Appearance Assessed by Investigator | 6 month | \- 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 Higher score = better improvement |
| Subject Improvement Assessment | 6 Months | 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. |
| Subject Satisfaction Assessment | 6 months | 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. Higher scores indicate greater satisfaction. |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized Age | 38.158 years STANDARD_DEVIATION 9.63 |
| Fitzpatrick Skin Type Type I | 1 Participants |
| Fitzpatrick Skin Type Type II | 5 Participants |
| Fitzpatrick Skin Type Type III | 4 Participants |
| Fitzpatrick Skin Type Type IV | 5 Participants |
| Fitzpatrick Skin Type Type V | 2 Participants |
| Fitzpatrick Skin Type Type VI | 0 Participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 17 |
| other Total, other adverse events | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 |
Outcome results
None listed