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Completed

NCT Number: NCT04599257

Fat Reduction and Muscle Toning of Thighs

This study will evaluate the clinical efficacy and safety of a simultaneous application of high-intensity focused electromagnetic procedure and radiofrequency energy for changes in subcutaneous fat tissue and muscle toning of thighs.

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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

Brian M. Kinney M.D., Inc, Beverly Hills, California, United States

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age > 21 years
  • Voluntarily signed an 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 her regular (pre-procedure) diet and exercise regimen without affecting significant change in either direction during study participation

Exclusion criteria

  • Electronic implants (such as cardiac pacemakers, defibrillators, and neurostimulators)
  • Metal implants
  • Drug pumps
  • Malignant tumor
  • Pulmonary insufficiency
  • Injured or otherwise impaired muscles
  • Cardiovascular diseases
  • Disturbance of temperature or pain perception
  • Hemorrhagic conditions
  • Septic conditions and empyema
  • Acute inflammations
  • Systemic or local infection such as osteomyelitis and tuberculosis
  • Contagious skin disease
  • Elevated body temperature
  • Pregnancy, postpartum period, nursing, and menstruation
  • Intrauterine device (IUD)
  • Swollen or neoplastic tissues, space-occupying lesions or skin eruptions in the treatment area
  • Basedow's disease

Treatment and study plan

BTL-899

Device

The device applicator combines high-intensity focused electromagnetic procedure and radiofrequency energy to induce visible muscle contractions along with heating of the subcutaneous fat.

Primary outcomes

  1. Evaluation of structural changes of subcutaneous tissues between pre-treatment and post-treatment based on MRI imaging

    Time frame: 7 months

    The primary objective of the study is to determine the effectiveness of a simultaneous application of high-intensity focused electromagnetic procedure and radiofrequency energy for change in the adipose layer thickness between pre-treatment and post-treatment based on MRI imaging. The changes will be considered statistically significant where p-value <0.05.

Secondary outcomes

  1. Assess subjects' satisfaction with the treatment using Subject Satisfaction Questionnaire

    Time frame: 7 months

    The 5-point Likert scale Satisfaction questionnaire will be used to evaluate the participant's satisfaction with the therapy outcome. Subject satisfaction will be assessed after the last therapy visit and during the follow-up visits with 4-therapy related questions with answer "Strongly agree" will be the best possible answer and "Strongly disagree" the worst.

  2. Assess safety profile by recording of adverse events

    Time frame: 7 months

    All AEs including local and systemic reactions not meeting the criteria for "serious adverse events" will be captured on the appropriate CRF. Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed only by those with the training and authority to make a diagnosis, which would include MD, DDS, DMD, PA, Nurse Practitioner or DO), and time of resolution/stabilization of the event. All AEs occurring during the study must be documented appropriately regardless of relationship to study device. All AEs will be followed to adequate resolution.

Sponsors and collaborators

Lead sponsor

BTL Industries Ltd.

Industry

Registry information

Official study title

Simultaneous Application of High-Intensity Focused Electromagnetic Procedure and Radiofrequency for Changes in Subcutaneous Fat Tissue and Muscle Toning of Thighs

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Oct 22, 2020
Registry last updated
Feb 9, 2022

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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