NCT06282172

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

Effect of Treatment With BTL-785F Device on Submental Subcutaneous Adipose Tissue - Histological Evaluation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: BTL Industries Ltd. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Fat Burn

Interventions

Type	Name	Description
DEVICE	Treatment with BTL-785-7	Treatment with BTL-785-7 delivering simultaneously radiofrequency (RF) and HIFES energy on the submental area

Timeline

• Start date: 2023-07-25
• Primary completion: 2023-10-31
• Completion: 2023-12-18
• First posted: 2024-02-28
• Last updated: 2025-02-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study