Histological Evaluation of BTL-785F Device's Effect on Submental Subcutaneous Adipose Tissue (NCT06282172) | Clinical Trial Compass
CompletedNot Applicable
Histological Evaluation of BTL-785F Device's Effect on Submental Subcutaneous Adipose Tissue
United States8 participantsStarted 2023-07-25
Plain-language summary
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.
Who can participate
Age range21 Years
SexALL
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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
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What they're measuring
1
Investigation of the effects of the BTL-785F device (with BTL-785-7 applicator) on the morphology of submental adipose cells.