BTL-785F Device for Non-invasive Lipolysis and Circumference Reduction of the Abdomen

Evaluation of the Safety and the Efficacy of the of BTL-785F Device for Non-invasive Lipolysis and Circumference Reduction of the Abdomen

This study will evaluate the clinical safety and the performance of the BTL-785F system equipped with BTL-785-1 applicator for non-invasive lipolysis (breakdown of fat) of the abdomen and reduction in circumference of the abdomen.

Safety measures will include documentation of adverse events (AE) during and after the procedures.

Follow-ups visits at 1 month and 3 months after the final treatment will be held.

Study Overview

• Status: Completed
• Conditions: Fat Burn
• Intervention / Treatment: Device: BTL-785F

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bulgaria
  • Pleven, Bulgaria
    • Ambulatory for Individual Practice for Specialized Outpatient Medical Care in Dermatology and Venereology Dr. Ivelina Yordanova-Vasileva
  • Sofia, Bulgaria
    • Dr. Lekova Derm Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy male or female subjects over 21 years of age seeking treatment for abdominal circumference reduction
• Subjects should be able understand the investigative nature of the treatment, the possible benefits and side effects, and must sign the Informed Consent Form
• Presence of clearly visible fat deposits in the abdominal area as deemed appropriate by the Investigator (e.g. by pinch test or ultrasound fat thickness measurement)
• Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring and/or weight loss during study participation.
• No procedure for abdominal fat reduction (including cellulite treatment) in the last six months.
• Subjects willing and able to maintain his/her regular (pre-procedure) diet and exercise regimen without effecting a significant change of weight in either direction during study participation.
• Willingness to comply with study instructions and to return to the clinic for required visits.

Exclusion Criteria:

• Bacterial or viral infection, acute inflammations
• Impaired immune system
• Isotretinoin use in the past 12 months
• Skin related autoimmune diseases
• Radiation therapy and/or chemotherapy
• Poor healing and unhealed wounds in the treatment area
• Metal implants
• Permanent implant in the treated area
• Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body
• Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles
• History of any type of cancer
• Active collagen diseases
• Cardiovascular diseases (such as vascular diseases, peripheral arterial disease, thrombophlebitis and thrombosis)
• Pregnancy/nursing or IVF procedure
• History of bleeding coagulopathies, use of anticoagulants
• Any active condition in the treatment area, such as sores, psoriasis, eczema, etc.
• Any surgical procedure in the treatment area within the last three months or before complete healing
• Poorly controlled endocrine disorders, such as diabetes
• Acute neuralgia and neuropathy
• Kidney or liver failure
• Sensitivity disorders in the treatment area
• Varicose veins, pronounced edemas
• Previous liposuction in the treatment area in the last six months
• Unstable weight within the last 6 months (change in weight ± 3%)
• Previous body contouring or cellulite treatments in the abdominal area in the last six months
• Any other disease or condition (e.g. hernia) at the investigator discretion that may pose risk to the patient or compromise the study

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: Non-invasive lipolysis and circumference reduction of the abdomen; The treatment administration phase consists of four (4) treatment visits, delivered at least 1 week apart. Follow-ups visits at 1 month and 3 months after the final treatment will be held.	Device: BTL-785F; Treatment with study device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Statistically significant reduction of abdominal fat thickness determined with ultrasound	To gather clinical evidence that BTL-785F system equipped with BTL-785-1 applicator is able to provide statistically significant reduction of at least 1,5 cm at the 3-months follow-up compared to baseline with a minimum response rate of 65% in both abdominal circumference and fat thickness.	5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the safety of the BTL-785F device with BTL-785-1 applicator for non-invasive lipolysis and circumference reduction of the abdomen	At every treatment visit after the first, prior to the procedure, the participants will be assessed for adverse effects resulting from the previous treatment(s) with the BTL-785F device. Safety measures will include documentation of adverse events (AE) during and after the procedures.	5 months
Assessment of the participants' satisfaction from the therapy measured via standard questionnaire	Minimum 80% of treated subjects to report satisfaction (level satisfied and higher) with the therapy;	5 months

Collaborators and Investigators

• Sponsor: BTL Industries Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2021
• Primary Completion (Actual): November 8, 2022
• Study Completion (Actual): January 26, 2023

Study Registration Dates

• First Submitted: November 3, 2020
• First Submitted That Met QC Criteria: November 3, 2020
• First Posted (Actual): November 9, 2020

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

• Keywords: non-invasive; lipolysis; circumference reduction
• Other Study ID Numbers: BTL-785F_ABL

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