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

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.

Study Overview

• Status: Completed
• Conditions: Fat Burn
• Intervention / Treatment: Device: BTL-899

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Skin Laser and Surgery Specialist, a Division of Schweiger Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age > 21 years
• Voluntarily signed an informed consent form
• BMI ≤ 35 kg/m2
• Women of child-bearing potential are required to use birth control measures during the whole duration of the study.
• Willingness to abstain from partaking in any treatments other than the study procedure
• Willingness to comply with study instructions, to return to the clinic for the required visits and to undergo punch biopsies in the abdominal area.

Exclusion Criteria:

• Electronic implants (such as cardiac pacemakers, defibrillators, and neurostimulators)
• Metal implants in the treated area
• Drug pumps
• Malignant tumor
• Pulmonary insufficiency
• Injured or otherwise impaired muscles in the treated area
• Cardiovascular diseases
• Disturbance of temperature or pain perception
• Hemorrhagic conditions
• Septic conditions and empyema
• Acute inflammations in the treated area
• Systemic or local infection such as osteomyelitis and tuberculosis
• Contagious skin disease
• Elevated body temperature
• Application during pregnancy, postpartum period, nursing, and menstruation
• Graves' disease
• Skin related autoimmune diseases that may contradict the biopsy
• Poor healing and unhealed wounds in the treatment area
• Any disease or condition contradicting the skin tissue biopsy
• Any disease or condition that may compromise the histologic observation at the pathologist discretion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Histological evaluation of BTL-899 device´s effect on fat tissue; This group will be treated with 100% of the treatment parameter settings	Device: BTL-899; BTL-899 treatment
Sham Comparator: Sham treatment; This group will be treated with 5% of the treatment parameter settings	Device: BTL-899; BTL-899 treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Increased caspase-3 activity	Biopsy samples of the abdominal fat tissue will be processed for histological evaluation by a certified laboratory. Conventional staining will be used to determine the changes in the fat tissue related to the increase in caspase-3 activity, which is associated with elevated levels of fat tissue apoptosis, and to examine other morphological changes of treated tissue, in all collected samples. Post-treatment findings will be compared to the baseline. The results of both study groups will be compared as well.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety assessment	Occurrence of adverse events	1 month

Collaborators and Investigators

• Sponsor: BTL Industries Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2021
• Primary Completion (Actual): April 27, 2022
• Study Completion (Actual): August 11, 2022

Study Registration Dates

• First Submitted: November 18, 2021
• First Submitted That Met QC Criteria: November 18, 2021
• First Posted (Actual): December 1, 2021

Study Record Updates

• Last Update Posted (Actual): August 26, 2022
• Last Update Submitted That Met QC Criteria: August 25, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: BTL-899_CTUS400

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