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

NCT04871503 | Completed FDA Device

• 1 other identifier: BTL-899_300
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Muscle Tone

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Patient's satisfaction with study treatment measured via questionnaires

  4 months

• Evaluation of the Therapy's Safety Measured Via Therapy Comfort Questionnaire

  4 months

Study Arms (2)

HIFEM+RF (HR)

EXPERIMENTAL

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

HIFEM (H)

EXPERIMENTAL

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

Interventions

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.

HIFEM (H); HIFEM+RF (HR)

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BTL Industries Ltd.: lead

Study Sites (5)

Contour Medical

Gilbert, Arizona, 85297, United States

Location

Skin Laser and Surgery Specialist, a Division of Schweiger Dermatology

Hackensack, New Jersey, 07601, United States

Location

New Jersey Plastic Surgery (NJPS)

Montclair, New Jersey, 07042, United States

Location

JUVA Skin & Laser Center

New York, New York, 10022, United States

Location

Refresh Dermatology

Houston, Texas, 77081, United States

Location

Study Officials

• Georgi Petkov

  Sponsor GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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. All of the study subjects will receive the treatment with the subject device.

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 4, 2021
• Study Start: March 1, 2021
• Primary Completion: October 6, 2021
• Study Completion: January 12, 2022
• Last Updated: February 9, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)