NCT05139745

Histological Evaluation of BTL-899 Device´s Effect on Fat Tissue

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: BTL Industries Ltd. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the safety and performance of the BTL-899 device for non-invasive treatment of subcutaneous fat. The changes in the fat tissue related to the activity of caspase-3 will be assessed histologically. The study is a prospective single-center single-blinded two-arm study. The subjects will be enrolled and assigned into two study groups; Group A which will receive active treatment and Group B which receives sham treatment and will serve as a control to verify the treatment outcomes. Subjects will be required to complete only one (1) treatment visit and three (3) follow-up visits (at 8 hours, 24 hours and 7 days post treatment). All of the study subjects will receive the treatment (either active or sham) with the subject device. At the baseline visit, health status will be assessed. Inclusion and exclusion criteria will be verified and informed consent will be signed. Punch biopsies from the treated abdominal area will be taken to examine the changes related to caspase-3 activity.

Conditions

• Fat Burn

Interventions

Type	Name	Description
DEVICE	BTL-899	BTL-899 treatment

Timeline

• Start date: 2021-10-11
• Primary completion: 2022-04-27
• Completion: 2022-08-11
• First posted: 2021-12-01
• Last updated: 2022-08-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study