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Completed

NCT Number: NCT04643275

Effect of BTL-899 Device for Non-invasive Lipolysis on Human Upper Arms

This study will evaluate the clinical safety and the performance of the BTL-899 device during the treatment of upper arms.

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Key information

Conditions

Fat Burn

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr Denkova Dermatology

Sofia, 1700, Bulgaria

About this study

The aim of the study is to confirm the efficacy and the safety of the treatment. The efficacy (reduction of excess adipose tissue) will be assessed via correct identification of pre-treatment and 3-months follow-up images by at least two out of three independent blinded evaluators. The fat reduction will be also measured by means of ultrasound. Comfort and satisfaction will be assessed via standard questionnaires.

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

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Body Mass Index (BMI) of 20 to 35 kg/m2.
  • Visible excess of adipose tissue at the treatment site
  • 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 fat reduction in the area 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 the study participation.

Exclusion criteria

  • Electronic implants (such as cardiac pacemakers, defibrillators, and neurostimulators)
  • Cardiovascular diseases
  • Vascular diseases (such as chronic venous insufficiency, deep venous thrombosis, varicose veins, etc.)
  • 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
  • Contagious skin disease
  • Elevated body temperature
  • Pregnancy
  • Breastfeeding
  • Injured or otherwise impaired muscles in the arms
  • Scars, open lesions, and wounds at the treatment area
  • Basedow's disease
  • Previous liposuction in the treatment area in the last six months
  • Any other disease or condition at the investigator's discretion, e.g. dislocated shoulder or carpal tunnel syndrome than can pose danger to the patient or compromise the study

Treatment and study plan

BTL-899

Device

Treatment with study device.

Primary outcomes

  1. Statistically significant reduction of fat thickness in the upper arms evaluated by photographs

    Time frame: 5 months

    To gather clinical evidence that the BTL-899 device is able to induce non-invasive lipolysis when used on upper arms. The primary efficacy outcome measure is a minimum 75% of the subjects' pre-treatment and 3-months follow-up images to be correctly identified by at least two of three independent blinded evaluators.

Secondary outcomes

  1. Evaluation of the Therapy's Safety Measured Via Therapy Comfort Questionnaire

    Time frame: 7 months

    Assessment the safety of the BTL-899 device when used for non-invasive lipolysis of the upper arms via questionnaires filled in by the participants following each therapy session. On Numerical Analog Scale (0-10), where 0 represents 'no pain' and 10 represents 'worst possible pain' select the level of pain experienced during the treatment. The outcome will further be measured through the occurrence of adverse events or lack thereof.

  2. Evaluation of the participants' satisfaction with the therapy evaluated via standard questionnaires

    Time frame: 5 months

    Evaluation of the participants' satisfaction with the therapy and the results. ● 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 25, 2020
Registry last updated
Sep 9, 2021

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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