BTL Industries Ltd started a new clinical trial for toning of buttocks

The company BTL Industries Ltd is enrolling patients into the clinical trial investigating HIFEM and RF 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.

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.

The trial is designed to enroll male and female 21 Years to 70 Years and is being conducted in the Contour Medical, Gilbert, Arizona, United States; Skin Laser and Surgery Specialist, a Division of Schweiger Dermatology, Hackensack, New Jersey, United States; New Jersey Plastic Surgery (NJPS), Montclair, New Jersey, United States; JUVA Skin & Laser Center, New York, New York, United States; Refresh Dermatology, Houston, Texas, United States.

The study start date is March 1, 2021.

The patients that can be enrolled into this study include:

  • 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.

The population that are excluded from participation:

  • 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.

This page provides a more detailed overview of this clinical trial: https://ichgcp.net/clinical-trials-registry/NCT04871503.

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