Effect of the BTL-899 Therapy for Non-invasive Lipolysis and Circumference Reduction of Abdomen

Evaluation of Safety and Efficacy of the BTL-899 Device for Non-invasive Lipolysis and Circumference Reduction of Abdomen

The study is a prospective open-label single-arm study that includes three treatment procedures and four follow-up visits.

Study Overview

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

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 open-label single-arm study. The subjects will be enrolled and assigned into a single study group. 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): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bulgaria
  • Sofia, Bulgaria, 1700
    • Aesthe Clinic

Participation Criteria

Eligibility Criteria

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

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: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BTL-899 Therapy Arm; BTL-899 therapy, 3 therapies	Device: BTL-899; BTL-899

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of the BTL-899 treatment for abdomen circumference reduction after the final follow-up visit	Evaluation of change in abdomen circumference using tape measurements in cm at the final follow-up visit.	4 months
Occurrence of adverse events	The occurrence of adverse events will be followed throughout the whole study.	7 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of BTL-899 treatment for fat and circumference reduction in abdomen, as assessed by two blinded evaluators	Evaluation of photographs before and after the treatment.	4 months
Efficacy of the BTL-899 treatment for abdomen circumference reduction	Evaluation of change in abdomen circumference using tape measurements in cm at all study visits after the first therapy.	4 months
Ultrasound imaging	Evaluation of ultrasound images.	4 months
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

Collaborators and Investigators

• Sponsor: BTL Industries Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): September 19, 2018
• Study Completion (Actual): October 3, 2018

Study Registration Dates

• First Submitted: August 30, 2017
• First Submitted That Met QC Criteria: August 31, 2017
• First Posted (Actual): September 1, 2017

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: BTL-899L

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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