Trim II for Noninvasive Lipolysis and Circumference Reduction of Abdomen.

NCT05398159 | Completed Results FDA Device

• 1 other identifier: DO609924A
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 5

Brief 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).

Conditions

Circumference Reduction of Abdomen

Outcome Measures

Primary Outcomes (2)

• Evaluation of Change in Abdomen Circumference Using Tape Measurements in cm at the 3 Months Follow-up Visit Comparing to Baseline.

  Efficacy of the Trim II treatment for lipolysis and abdominal circumference reduction. Evaluation of change in abdomen circumference using tape measurements in cm at the 3 months follow-up visit comparing to baseline. Success criteria: Statistically significant reduction in abdominal circumference tape measurements at the 3 months follow-up visit compared to baseline

  3 months

• Safety of the Trim II Treatment for Lipolysis and Abdominal Circumference Reduction.

  Number of participants with 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 Outcomes (4)

• Percentage of Participants With Baseline and 3 Month Abdomen Photographs Correctly Identified by Two Blind Evaluators

  3 months

• Change in Abdominal Fat Thickness Measured by Ultrasound Imaging (USI) at the 3 Months Follow-up Visit Comparing to Baseline.

  3 months

• Subject's Satisfaction With Study Treatment at 3 Months Follow-up Visit.

  3 months

• Treatment Comfort During the Study Treatment.

  Immediately post each treatment once in 2 weeks for 6 weeks

Study Arms (1)

treatment

EXPERIMENTAL

3 bi-weekly treatments

Device: Trim II

Interventions

Trim II DEVICE

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).

treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• InMode MD Ltd.: lead

Study Sites (5)

H/K/B Cosmetic Surgery

Huntersville, North Carolina, 28078, United States

Location

Bucky Body Center

Philadelphia, Pennsylvania, 19103, United States

Location

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

Dallas Plastic Surgery Institute

Dallas, Texas, 75231, United States

Location

Refresh Dermatology

Houston, Texas, 77081, United States

Location

Related Publications (1)

• Labadie JG, Chilukuri S, Cohen J, Kilmer S, Lupo M, Rohrich R, Dover JS. Noninvasive Hands-free Bipolar Radiofrequency Facial Remodeling Device for the Improvement of Skin Appearance. Dermatol Surg. 2023 Jan 1;49(1):54-59. doi: 10.1097/DSS.0000000000003666. Epub 2022 Dec 8.

  PMID: 36533797 DERIVED

Results Point of Contact

• Title: Maria Shusterman
• Organization: InMode

Maria.Shusterman@inmodemd.com

9057076787

Publication Agreements

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

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: May 17, 2022
• First Posted: May 31, 2022
• Study Start: March 10, 2021
• Primary Completion: October 30, 2022
• Study Completion: October 30, 2022
• Last Updated: June 11, 2024
• Results First Posted: June 11, 2024

Record last verified: 2024-06

Locations

US (5)