Trim II for Noninvasive Lipolysis and Circumference Reduction of Abdomen.

Study Overview
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Brief Summary
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At least 90 female and male subjects, from 6 investigational sites, aged 18-70 seeking non-invasive lipolysis and circumference reduction of abdomen will be enrolled. Eligible subjects will receive 3 bi-weekly treatments (once in 2 weeks) with Trim II hands-free applicator belt according to the study protocol.Study duration for each subject is approximately 6 months (including screening, 3 treatments and 2 follow-up visits at 1 and 3 months post last treatment).

Official Title
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Safety and Efficacy of Trim II for Non-invasive Lipolysis and Circumference Reduction of Abdomen

Conditions
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Circumference Reduction of Abdomen

Intervention / Treatment
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* Device: Trim II


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female and male subjects, aged 18-70. BMI≤ 30. Subjects seeking non-invasive lipolysis and circumference reduction of abdomen Female should not be pregnant or 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. The subjects should understand the information provided about the investigative nature of the treatment, possible benefits and side effects, and sign the Informed Consent Form, including permission to use photography. The subjects should be willing to comply with the study procedure and schedule, including the follow up visits, and will refrain from using any other abdominal treatment methods during the entire study period. Exclusion Criteria: - Active electrical implant/device in any region of the body, including pacemaker or internal defibrillator Permanent implant in the treated area such as metal plates, screws or silicon, metal piercing or other. 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. History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin. History of bleeding coagulopathies or use of anticoagulants except for low-dose aspirin. 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. Impaired immune system due to immunosuppressive diseases such as AIDS and HIV or use of immunosuppressive medications. Pregnancy and nursing. Poorly controlled endocrine disorders, such as Diabetes, or thyroid dysfunction and hormonal virilization. Isotretinoin (Accutane) within last 6 months. Any active condition in the treatment area, such as sores, Psoriasis, eczema, and rash, open lacerations, abrasions or lesions, infection in the area to be treated. Any surgical procedure in the treatment area within the last 12 months or before complete healing. Having received treatment with light, laser, RF, or other devices in the treated area within 2-3 weeks for non-ablative procedures, and 6-12 weeks for ablative fractional laser resurfacing (according to treatment severity) prior to treatment, except special recommendations. Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g., ibuprofen-containing agents) one week before and after each treatment session, as per the practitioner's discretion. As per the investigator's discretion, refrain from treating any condition which might make it unsafe for the patient. Participated in another investigational drug or device study or have completed the follow-up phase for any previous study less than 30 days prior to the first evaluation in this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment<br>3 bi-weekly treatments | Device: Trim II<br>* Eligible subjects will receive 3 bi-weekly treatments (once in 2 weeks) with Trim II hands-free applicator belt according to the study protocol. Trim II hands-free applicator composed of 4 units applied to the abdominal area, using a single-use belt. Each treatment duration will be 45-60 minutes. Study duration for each subject is approximately 6 months (including screening, 3 treatments and 2 follow-up visits at 1 and 3 months post last treatment).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of the Trim II treatment for lipolysis and abdominal circumference change. | Evaluation of change in abdomen circumference using tape measurements in cm at the 3 months follow-up visit comparing to baseline. | 3 months | 
| Safety of the Trim II treatment for lipolysis and abdominal circumference change. | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) will be followed throughout the whole study. Observation, assessment, and recording of potential reactions by the investigator. Evaluations will be done immediately after each treatment and at the follow-up visits. The frequency, severity, and causality of reactions will be recorded. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of the Trim II treatment for fat and circumference change in abdomen, as assessed by two blinded evaluators | Success criteria: Correct identification of baseline and 3-month follow-up visit photographs of the abdomen (treatment) area in at least 70% of treated subjects by two blinded evaluators. | 3 months | 
| Change in abdominal fat thickness measured by ultrasound imaging (USI) at the 3 months follow-up visit comparing to baseline. | Success criteria: statistically significant change in fat thickness of the abdomen (treatment) area measurements at the 3 months follow-up visit compared to baseline. | 3 months | 
| Subject's satisfaction with study treatment at 3 months follow-up visit. | Subject's satisfaction with the therapy results evaluated through the Subject Satisfaction Questionnaire (5-point scale). The higher the score the better the outcome | 3 months | 
| Treatment comfort during the study treatment. | Subjects will be asked to rate discomfort using Subject's discomfort (pain) level after each treatment evaluated using the Therapy Comfort Questionnaire. Scored from-2 to +2. The higher the score the better the outcome. | Treatment 1, treatment 2, treatment 3, up to 1 month |