Histological Evaluation of BTL-785F Device's Effect on Submental Subcutaneous Adipose Tissue

BTL

Status

Completed

Conditions

Fat Burn

Treatments

Device: Treatment with BTL-785-7

Study type

Interventional

Funder types

Industry

Identifiers

NCT06282172

BTL-785_CTUS1600

Details and patient eligibility

About

This study aims to evaluate the safety and effectiveness of the BTL-785F system equipped with the BTL-785-7 applicator for non-invasive reduction of subcutaneous submental fat.

Full description

This study aims to evaluate the safety and effectiveness of the BTL-785F system equipped with the BTL-785-7 applicator for non-invasive reduction of subcutaneous submental fat. The changes in the fat tissue related to the morphology (shape, size and count) will be assessed histologically. The presence of biochemical apoptotic indicators will be analysed in the adipocytes.

The study is a prospective single-center open-label two-arm study. The subjects will be enrolled and assigned into two study groups; Group A which will receive active treatment (5 subjects) and Group B (2 subjects), will serve as the control, and will not receive any treatment to verify the treatment outcomes.

Subjects will be required to complete one (1) treatment visit and three (3) follow-up visits (at 24 hours, 7 days and 14 days post treatment). The third follow-up visit is for safety evaluation.

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

Punch biopsies (3mm diameter) will be obtained from the treatment area for histologic analysis. In the control group, biopsy will be obtained from the location corresponding to the treatment area in the active group.

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

Enrollment

8 patients

Sex

All

Ages

21+ years old

Volunteers

Accepts Healthy Volunteers

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 undergo punch biopsy of the submental area

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)
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 edemas
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