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

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

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

Study Overview

• Status: Unknown
• Conditions: Improvement of Abdomen Appearance
• Intervention / Treatment: Device: BTL-899; Device: Sham

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham Arm	Device: Sham; Sham treatment with BTL-899 device, 3 visits
Experimental: BTL-899 Therapy Arm	Device: BTL-899; Treatment with BTL-899 device, 3 therapies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of adverse events	The occurrence of adverse events will be followed throughout the whole study.	7 months
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject's satisfaction with study treatment	Subject's satisfaction with the therapy results evaluated through the Subject Satisfaction Questionnaire (5-point scale).	4 months
Therapy comfort during the study treatment.	Therapy comfort during the treatment evaluated through the Therapy Comfort Questionnaire (10-point scale).	1 month
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
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
Efficacy of the BTL-899 treatment for abdominal fat reduction	Comparison of fat reduction between two study groups using ultrasound images.	4 months

Collaborators and Investigators

• Sponsor: BTL Industries Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2018
• Primary Completion (Anticipated): December 3, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: June 25, 2019
• First Submitted That Met QC Criteria: June 26, 2019
• First Posted (Actual): June 27, 2019

Study Record Updates

• Last Update Posted (Actual): June 27, 2019
• Last Update Submitted That Met QC Criteria: June 26, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: BTL-899S

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No