Trim II for Noninvasive Lipolysis and Circumference Reduction of Abdomen.

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

NCT05398159•InMode MD Ltd.

Summary

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).

Detailed Description

The goal of this prospective study is to evaluate Safety and Efficacy of Trim II for Non-invasive Lipolysis and Circumference Reduction of Abdomen. The main questions are : * Efficacy of the Trim II treatment for lipolysis and abdominal circumference reduction. * Safety of the Trim II treatment for lipolysis and abdominal circumference reduction Eligible subjects will receive 3 bi-weekly treatments (once in 2 weeks) with Trim II hands-free applicator belt according to the study protocol.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Yes

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.
+7 more criteria

Locations (5)

H/K/B Cosmetic Surgery

Huntersville, North Carolina, United States

Bucky Body Center

Philadelphia, Pennsylvania, United States

Tennessee Clinical Research Center

Nashville, Tennessee, United States

Dallas Plastic Surgery Institute

Dallas, Texas, United States

Refresh Dermatology

Houston, Texas, United States

Key Dates

Start Date

March 10, 2021

Primary Completion Date

October 30, 2022

Completion Date

October 30, 2022

Last Updated

June 11, 2024

Enrollment

ACTUAL participants

Conditions

Circumference Reduction of Abdomen

Interventions

Trim II

DEVICE