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Completed

NCT Number: NCT04621019

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.

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Key information

Conditions

Fat Burn

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BTL-785F

Device

Treatment with study device.

Primary outcomes

  1. Statistically significant reduction of abdominal fat thickness determined with ultrasound

    Time frame: 5 months

    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.

Secondary outcomes

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

    Time frame: 5 months

    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.

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

    Time frame: 5 months

    Minimum 80% of treated subjects to report satisfaction (level satisfied and higher) with the therapy;

Sponsors and collaborators

Lead sponsor

BTL Industries Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Nov 9, 2020
Registry last updated
Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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