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

NCT04621019 | Completed

• 1 other identifier: BTL-785F_ABL
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Fat Burn

Keywords

lipolysis; circumference reduction; non-invasive

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Evaluation of the safety of the BTL-785F device with BTL-785-1 applicator for non-invasive lipolysis and circumference reduction of the abdomen

  5 months

• Assessment of the participants' satisfaction from the therapy measured via standard questionnaire

  5 months

Study Arms (1)

Non-invasive lipolysis and circumference reduction of the abdomen

EXPERIMENTAL

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

Interventions

BTL-785F DEVICE

Treatment with study device.

Non-invasive lipolysis and circumference reduction of the abdomen

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• BTL Industries Ltd.: lead

Study Sites (2)

Ambulatory for Individual Practice for Specialized Outpatient Medical Care in Dermatology and Venereology Dr. Ivelina Yordanova-Vasileva

Pleven, Bulgaria

Location

Dr. Lekova Derm Ltd.

Sofia, Bulgaria

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2020
• First Posted: November 9, 2020
• Study Start: November 11, 2021
• Primary Completion: November 8, 2022
• Study Completion: January 26, 2023
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

BU (2)