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Completed

NCT Number: NCT04871503

High-Intensity Focused Electromagnetic Procedure and Radiofrequency for Toning of Buttocks

This study will evaluate the clinical efficacy and safety of the BTL-899 device for toning of buttocks. The study is a prospective multi-center open-label two-arm study. The subjects will be enrolled and assigned into two study groups. The subjects will be enrolled and assigned into two study groups; HIFEM+RF (HR) and HIFEM (H) group. Subjects of both groups will be required to complete four (4) treatment visits and two follow-up visits.

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Key information

Conditions

Muscle Tone

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Contour Medical, Gilbert, Arizona, 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 Buttocks

Device

The treatment administration phase in both study groups will consist of four (4) treatments, delivered 5-10 days apart. The applicators of BTL-899 will be applied over the gluteal area.

Primary outcomes

  1. The evaluation of change in structure of subcutaneous tissues between pre-treatment and post-treatment based on MRI imaging in both study groups.

    Time frame: 4 months

    The evaluation of structural changes of subcutaneous tissues between pre-treatment and post-treatment based on MRI imaging through measurements of the thickness of subcutaneous tissues

  2. The evaluation of change in adipose and muscle layer thickness.

    Time frame: 4 months

    The evaluation of change in adipose and muscle layer thickness between pre-treatment and post-treatment based on hip circumference measurements.

Secondary outcomes

  1. Patient's satisfaction with study treatment measured via questionnaires

    Time frame: 4 months

    To determine the patient's satisfaction with study treatment. 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 4therapy-related questions, where the answer "Strongly agree" will be the best possible answer and "Strongly disagree" the worst.

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

    Time frame: 4 months

    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.

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 Toning of Buttocks

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
May 4, 2021
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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