Effect of the BTL-899 Therapy for Non-invasive Lipolysis and Circumference Reduction of Abdomen When Compared to a Sham Treatment

Improvement of Abdomen Appearance Clinical Trial

Official title:

Evaluation of Safety and Efficacy of the BTL-899 Device for Non-invasive Lipolysis and Circumference Reduction of Abdomen When Compared to a Sham Treatment

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04000945
• Other study ID #: BTL-899S
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 3, 2018
• Est. completion date: December 31, 2019

Study information

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

Clinical Trial Summary

The study is a prospective single-blinded two-arms study that includes three treatment procedures and four follow-up visits

Description:

This study will evaluate the clinical efficacy and safety of the BTL-899 device for non-invasive lipolysis and circumference reduction of abdomen. The study is a prospective single-blinded two-arms study. The subjects will be enrolled and assigned into a two study groups. All subjects will complete three (3) treatment visits and will be invited to four (4) follow-up visits 1, 2, 3 and 6-months after the final treatment. 6-months follow-up visit is the optional one.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 31, 2019
• Est. primary completion date: December 3, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

• Age > 21 years

• Voluntarily signed 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

• Subjects willing and able to abstain from partaking in any treatments other than the study 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:

• Cardiac pacemakers

• Cardiovascular diseases

• Implanted defibrillators, implanted neurostimulators

• Electronic implants

• 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

• Contageous 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

• Previous body contouring treatments in the abdomen area in the last three months

Related Conditions & MeSH terms

• Improvement of Abdomen Appearance

Intervention

Device:
• BTL-899
Treatment with BTL-899 device, 3 therapies
• Sham
Sham treatment with BTL-899 device, 3 visits

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	Efficacy of the BTL-899 treatment for change in abdominal circumference	Comparison of change in abdominal circumference at the final follow-up visit between two study groups.	4 months
Primary	Occurrence of adverse events	The occurrence of adverse events will be followed throughout the whole study.	7 months
Secondary	Efficacy of BTL-899 treatment for abdominal fat and circumference reduction, as assessed by two blinded evaluators	Evaluation of aesthetic improvement achieved by abdominal fat and circumference reduction using photographs before and after the treatment.	4 months
Secondary	Efficacy of the BTL-899 treatment for change in abdominal circumference	Comparison of change in abdominal circumference at all study visits after the first therapy between two study groups.	4 months
Secondary	Efficacy of the BTL-899 treatment for abdominal fat reduction	Comparison of fat reduction between two study groups using ultrasound images.	4 months
Secondary	Subject's satisfaction with study treatment	Subject's satisfaction with the therapy results evaluated through the Subject Satisfaction Questionnaire (5-point scale).	4 months
Secondary	Therapy comfort during the study treatment.	Therapy comfort during the treatment evaluated through the Therapy Comfort Questionnaire (10-point scale).	1 month