Clinical Evaluation of the BTL-899 Device for Non-invasive Lipolysis on Human Fat Tissue

The subjects will be enrolled and assigned to a single study group. They will be required to complete two treatment visits and come for a biopsy procedure.

Study Overview

• Status: Completed
• Conditions: Improvement of Abdomen Appearance
• Intervention / Treatment: Device: BTL-899

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bulgaria
  • Sofia, Bulgaria, 1700
    • Dr. Denkova Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age above 21 years and below 60 years
• Voluntarily signing of the informed consent form
• Women of child-bearing potential are required to use birth control measures during the whole duration of the study
• Eligibility to fat tissue biopsy at surgeon discretion, incl. at least 3-4 cm pinchable fat in the abdominal area
• Subjects willing and able to abstain from partaking in any procedure to promote body contouring during study participation
• Subjects willing and able to maintain his/her regular (pre-procedure) diet and exercise regimen without effecting significant change in either direction during study participation

Exclusion Criteria:

• Electronic implants (such as cardiac pacemakers, defibrillators and neurostimulators)
• Cardiovascular diseases
• Disturbance of temperature or pain perception
• Pulmonary insufficiency
• Metal implants
• Drug pumps
• Malignant tumor
• Hemorrhagic conditions
• Septic conditions and empyema
• Acute inflammations
• Systemic or local infection such as osteomyelitis and tuberculosis
• Contagious skin disease
• Elevated body temperature
• Pregnancy
• Breastfeeding
• Injured or otherwise impaired muscles
• Scars, open lesions and wounds at the treatment area
• Basedow's disease
• Previous liposuction in the treatment area in the last six months
• Abdominal wall diastasis
• Unstable weight within the last 6 months (change in weight ± 3%)
• Previous body contouring treatments in the abdomen area in the last three months
• Any disease or condition contradicting the fat tissue biopsy at the surgeon discretion
• 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: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: BTL-899 Therapy Arm	Device: BTL-899; BTL-899 therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histology Examination	Histological examination of the fat tissue after BTL-899 treatment at various days after the procedure	4 months
Evaluation of Satefy: Occurence of adverse events throughout the study	Following the occurence of adverse events throughout the study.	4 months

Collaborators and Investigators

• Sponsor: BTL Industries Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2019
• Primary Completion (ACTUAL): September 17, 2019
• Study Completion (ACTUAL): October 7, 2019

Study Registration Dates

• First Submitted: April 18, 2019
• First Submitted That Met QC Criteria: April 22, 2019
• First Posted (ACTUAL): April 23, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 20, 2019
• Last Update Submitted That Met QC Criteria: December 18, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 899-H1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No