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.

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Key information

Conditions

Fat Burn

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Skin Laser and Surgery Specialist, a Division of Schweiger Dermatology

Hackensack, New Jersey, 07601, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BTL-899

Device

BTL-899 treatment

Primary outcomes

Increased caspase-3 activity

Time frame: 1 month

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.

Secondary outcomes

Safety assessment

Time frame: 1 month

Occurrence of adverse events

Sponsors and collaborators

Lead sponsor

BTL Industries Ltd.

Industry

Registry information

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Dec 1, 2021
Registry last updated: Aug 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed