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

Simultaneous Application of 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.

Study Overview

• Status: Completed
• Conditions: Muscle Tone
• Intervention / Treatment: Device: BTL-899 Buttocks

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Gilbert, Arizona, United States, 85297
      • Contour Medical
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Skin Laser and Surgery Specialist, a Division of Schweiger Dermatology
    • Montclair, New Jersey, United States, 07042
      • New Jersey Plastic Surgery (NJPS)
  • New York
    • New York, New York, United States, 10022
      • JUVA Skin & Laser Center
  • Texas
    • Houston, Texas, United States, 77081
      • Refresh Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HIFEM+RF (HR); The HR group will receive treatment with intensities of a magnetic field and radiofrequency energy just below the patient's tolerance threshold. The device will induce visible muscle contractions along with mild heating of the muscles.	Device: BTL-899 Buttocks; 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.
Experimental: HIFEM (H); The H group will receive a treatment with the intensities of the magnetic field just below the patient's tolerance threshold without the use of radiofrequency.	Device: BTL-899 Buttocks; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The evaluation of change in structure of subcutaneous tissues between pre-treatment and post-treatment based on MRI imaging in both study groups.	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	4 months
The evaluation of change in adipose and muscle layer thickness.	The evaluation of change in adipose and muscle layer thickness between pre-treatment and post-treatment based on hip circumference measurements.	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient's satisfaction with study treatment measured via questionnaires	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.	4 months
Evaluation of the Therapy's Safety Measured Via Therapy Comfort Questionnaire	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.	4 months

Collaborators and Investigators

• Sponsor: BTL Industries Ltd.
• Investigators: Study Director: Georgi Petkov, Sponsor GmbH

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): October 6, 2021
• Study Completion (Actual): January 12, 2022

Study Registration Dates

• First Submitted: April 29, 2021
• First Submitted That Met QC Criteria: April 29, 2021
• First Posted (Actual): May 4, 2021

Study Record Updates

• Last Update Posted (Actual): February 9, 2022
• Last Update Submitted That Met QC Criteria: February 8, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: BTL-899_300

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No