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

Improvement of Abdomen Appearance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03923855
• Other study ID #: 899-H1
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: October 7, 2019

Study information

• Verified date: December 2019
• Source: BTL Industries Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: October 7, 2019
• Est. primary completion date: September 17, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Improvement of Abdomen Appearance

Intervention

Device:
• BTL-899
BTL-899 therapy

Locations

Country	Name	City	State
Bulgaria	Dr. Denkova Dermatology	Sofia

Sponsors (1)

Lead Sponsor	Collaborator
BTL Industries Ltd.

Country where clinical trial is conducted

Bulgaria, 

Outcome

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