Clinical trial NCT05139745: Histological Evaluation of BTL-899 Device´s Effect on Fat Tissue
Official title: Histological Evaluation of BTL-899 Device´s Effect on Fat Tissue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fat Burn
Lead sponsor: BTL Industries Ltd.
Sponsor class: INDUSTRY
First posted: 2021-12-01
Enrollment: 7
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Increased caspase-3 activity
timeFrame: 1 month
Secondary outcomes:
measure: Safety assessment
timeFrame: 1 month
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Skin Laser and Surgery Specialist, a Division of Schweiger Dermatology
state: New Jersey
Study officials:
References: