rPMS and Radiofrequency for Abdominal Toning and Reduction of Subcutaneous Fat

Fat Burn Clinical Trial

Official title:

Efficacy of Simultaneous Application of Noninvasive Repetitive Pulse Magnetic Stimulation (rPMS) and Radiofrequency for Abdominal Toning and Reduction of Subcutaneous Fat: Single-Blind Randomized Sham-Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04587986
• Other study ID #: BTL-703_200
• Status: Completed
• Phase: N/A
• Start date: July 30, 2019
• Est. completion date: March 16, 2021

Study information

• Verified date: March 2021
• 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 a simultaneous treatment by high power magnet and radiofrequency energy for toning of abdomen and reduction of subcutaneous fat. The study is a prospective multi-center single-blinded sham-controlled study. The subjects will be enrolled and assigned into two study groups; active and sham group. Subjects of both groups will be required to complete three (3) treatment visits and two to three follow-up visits.

Description:

This study will evaluate the clinical efficacy and safety of a simultaneous treatment by high power magnet and radiofrequency energy for toning of abdomen and reduction of subcutaneous fat. The study is a prospective multi-center single-blinded sham-controlled study. The subjects will be enrolled and assigned into two study groups; active and sham group. Subjects of both groups will be required to complete three (3) treatment visits and two to three follow-up visits.

At the baseline visit, ultrasound imaging will be performed; the subject's weight and waist circumference will be recorded. Photos of the treated area will be taken.

The treatment administration phase in both study groups will consist of three (3) treatments, delivered once a week. The applicator of BTL-703 will be applied over the umbilicus. The active 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 heating of the subcutaneous fat. The sham group will receive a treatment with the intensities of the magnetic field and radiofrequency energy set to 5% of the maximum device output.

At the last therapy visit, the subject's weight and waist circumference will be recorded, and photos of the treated area will be taken. In addition, subjects will receive Subject Satisfaction Questionnaire to fill in.

Safety measures will include documentation of adverse events (AE) including the subject's experience of pain or discomfort after each procedure. Following each treatment administration and at all of the follow-up visits, subjects will be checked for immediate post-procedure adverse event assessment.

During the post-procedure visits (at 1-month and 3-month follow-up visits), the subjects will undergo ultrasound imaging. Also, the subject's satisfaction will be noted, and weight with waist circumference will be recorded. Photographs of the treated area will be taken. There will be an option of a 6-months follow-up visit, according to subject's availability.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: March 16, 2021
• Est. primary completion date: June 16, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Voluntarily signed 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

• Fat Burn

Intervention

Device:
• BTL-899
Treatment with intensities of a magnetic field and radiofrequency energy just below the patient's tolerance threshold.

Locations

Country	Name	City	State
United States	Maryland Laser Skin and Vein Institute	Hunt Valley	Maryland
United States	JUVA Skin & Laser Center	New York	New York
United States	Julene B. Samuels	River Bluff	Kentucky

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	Changes in fat and muscle thickness in the abdominal area measured via ultrasound.	To gather clinical evidence on the effectiveness of the combined treatment for abdominal toning and subcutaneous fat reduction through changes in abdominal tissues, measured via ultrasound and comparison of active and sham groups. The changes will be considered statistically significant where p-value <0.05.	7 months
Secondary	Patient's satisfaction with study treatment measured via questionnaires	To determine the patient's satisfaction with study treatment for non-invasive aesthetic improvement of the abdomen. 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.	7 months
Secondary	Evaluation of the Therapy's Safety Measured Via Therapy Comfort Questionnaire	The outcome will further be measured through the occurrence of adverse events or lack thereof. 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.	7 months