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

Muscle Tone Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04871503
• Other study ID #: BTL-899_300
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: January 12, 2022

Study information

• Verified date: February 2022
• Source: BTL Industries Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: January 12, 2022
• Est. primary completion date: October 6, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscle Tone

Intervention

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.

Locations

Country	Name	City	State
United States	Contour Medical	Gilbert	Arizona
United States	Skin Laser and Surgery Specialist, a Division of Schweiger Dermatology	Hackensack	New Jersey
United States	Refresh Dermatology	Houston	Texas
United States	New Jersey Plastic Surgery (NJPS)	Montclair	New Jersey
United States	JUVA Skin & Laser Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
BTL Industries Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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