Evaluation of the BTL-785F Device for Submental Fat Reduction and Neck Rejuvenation

Evaluation of the Safety and Efficacy of the BTL-785F Device for Non-invasive Submental Fat Reduction and Neck Rejuvenation

This study will evaluate the clinical safety and the performance of the BTL-785F system equipped with the BTL-785-7 applicator for non-invasive reduction of submental fat and skin laxity treatment.

Study Overview

• Status: Active, not recruiting
• Conditions: Fat Burn
• Intervention / Treatment: Device: BTL-785-7

Detailed Description

This is a multi center single-arm, open-label, interventional study.

The subjects will be enrolled and assigned into one experimental study arm. The subjects will be required to complete four (4) treatment visits and two follow-up visits.

At baseline inclusion and exclusion criteria will be verified upon obtaining informed consent from the patient.

The treatment administration phase consists of four (4) treatment visits, delivered 5-10 days apart. Follow-ups visits at 1 month and 3 months after the final treatment will be held.

At every treatment visit after the first, prior to the procedure, the participants will be assessed for adverse effects resulting from the previous treatment(s) with the BTL-785F device.

Safety measures will include documentation of adverse events (AE) during and after the procedures and if needed medical assistance.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Davie, Florida, United States, 33328
      • Precision Skin LLC
  • Illinois
    • Chicago, Illinois, United States, 60654
      • Chicago Cosmetic and Dermatologic Research
  • New Jersey
    • Montclair, New Jersey, United States, 07042
      • New Jersey Plastic Surgery (NJPS)
  • Ohio
    • Youngstown, Ohio, United States, 44512
      • Gentile Facial Plastic and Aesthetic Laser Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy male or female subjects over 21 years of age seeking treatment for reduction of submental fat
• Subjects should be able understand the investigative nature of the treatment, the possible benefits and side effects, and must sign the Informed Consent Form
• Presence of clearly visible excess fat in submentum as deemed appropriate by the Investigator
• Subjects willing and able to abstain from partaking in any facial treatments other than the study procedure during study participation
• Willingness to comply with study instructions, to return to the clinic for the required visits, and to have photographs of their face taken

Exclusion Criteria:

• Local bacterial or viral infection in the area to be treated
• Local acute inflammation in the area to be treated
• Impaired immune system caused by any immunosuppressive illness, disease or medication
• Isotretinoin and tretinoin-containing medication use in the past 12 months
• Skin related autoimmune diseases
• Radiation therapy and/or chemotherapy
• Poor healing and unhealed wounds in the treatment area
• Metal implants
• Permanent implant in the treated area
• Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body
• Facial dermabrasion, facial resurfacing, or deep chemical peeling in the treatment area within 3 months prior to the treatment
• Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles
• History of skin disorders, keloids, abnormal wound healing and dry or fragile skin
• History of any type of cancer
• Active collagen diseases
• Cardiovascular diseases (such as vascular diseases, peripheral arterial disease, thrombophlebitis, hypersensitive carotid sinus and thrombosis)1
• Pregnancy/nursing or IVF procedure
• History of bleeding coagulopathies, use of anticoagulants
• Any active condition in the treatment area, such as sores, psoriasis, eczema, rash and rosacea
• Any surgical procedure in the treatment area within the last three months or before complete healing
• Poorly controlled endocrine disorders, such as diabetes
• Acute neuralgia and neuropathy
• Kidney or liver failure
• Nerve insensitivity (sensitivity disorders) to heat in the treatment area
• Varicose veins, pronounced edemas1
• Prior use of dermal fillers, botulinum toxin, lasers, etc. therapies in the treated area that can influence the study results at the investigator discretion
• Unwillingness/inability to not change their usual cosmetics and especially not to use fat reduction, anti-aging or anti-wrinkles products in the treated area during the duration of the study including the follow-up period
• Electroanalgesia without exact diagnosis of pain etiology
• Neurological disorders (such as multiple cerebrospinal sclerosis, epilepsy)
• Blood vessels and lymphatic vessels inflammation
• Any other disease or condition at the investigator discretion that may pose risk to the patient or compromise the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment with BTL-785-7; Treatment with BTL-785F device (BTL-785-7 applicator)	Device: BTL-785-7; Treatment with the BTL-785F device with the BTL-785-7 applicator for non-invasive reduction of submental fat and skin laxity treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Submental fat thickness reduction	The primary efficacy outcome measure is a statistically significant reduction of at least 1.0 mm in the average submental fat layer thickness in the majority of subjects measured by MRI at 3-months follow-up compared to baseline.	15 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-related Adverse Events	To evaluate the safety of the BTL-785F device with the BTL-785-7 applicator for non-invasive reduction of submental fat through monitoring of adverse reactions.	15 months
Change on the Clinician Reported - Submental Fat Rating Scale score	Evaluation of the change in the Clinician Reported - Submental Fat Rating Scale (CR-SMFRS) grade. The scale ranges from grade 0 (no evident submental fat) to grade 4 (extreme submental convexity). Photographs from the last therapy, 1 month and 3 months follow-up will be compared to baseline photographs. An improvement is considered a decrease of the grade in the Clinician Reported - Submental Fat Rating Scale.	15 months
Satisfaction Assessed by the Satisfaction Questionnaire	The 5-point Likert scale Subject Satisfaction Questionnaire will be used for evaluating the satisfaction. The Subject Satisfaction Questionnaire will be given to subjects after the last therapy, at 1-month and 3-month follow-up. The answers to the questions related to the subjects' under-chin and overall facial appearance will vary from "strongly agree" to "strongly disagree".	15 months
Change in the submental-cervical angle	Statistically significant change in submental-cervical angle (SCA) convexity in the majority of the subjects	15 months
Comfort Assessed by Therapy Comfort Questionnaire	The 5-point Likert scale Therapy Comfort questionnaire will be used for evaluating the comfort during the treatment sessions. Pain sensation will be rated by the subjects from 0 (no pain) to 10 (worst possible pain). The Therapy Comfort questionnaire will be given to subjects after the last therapy.	15 months

Collaborators and Investigators

• Sponsor: BTL Industries Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: February 7, 2024
• First Submitted That Met QC Criteria: February 15, 2024
• First Posted (Estimated): February 23, 2024

Study Record Updates

• Last Update Posted (Estimated): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: fat; submentum; neck rejuvenation; double chin
• Other Study ID Numbers: BTL-785_CTUS1400

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No