rPMS and Radiofrequency for Abdominal Toning and Reduction of Subcutaneous Fat

NCT04587986 | Completed FDA Device

• 1 other identifier: BTL-703_200
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Fat Burn

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Patient's satisfaction with study treatment measured via questionnaires

  7 months

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

  7 months

Study Arms (2)

Abdominal Toning and Reduction of Subcutaneous Fat

EXPERIMENTAL

The treatment administration phase 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.

Device: BTL-899

Sham control

SHAM COMPARATOR

The treatment administration phase will also consist of three (3) treatments, delivered once a week. 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.

Device: BTL-899

Interventions

BTL-899 DEVICE

Treatment with intensities of a magnetic field and radiofrequency energy just below the patient's tolerance threshold.

Abdominal Toning and Reduction of Subcutaneous Fat; Sham control

Eligibility Criteria

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

You may qualify if:

• 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

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 (3)

Julene B. Samuels

River Bluff, Kentucky, 40059, United States

Location

Maryland Laser Skin and Vein Institute

Hunt Valley, Maryland, 21030, United States

Location

JUVA Skin & Laser Center

New York, New York, 10022, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 14, 2020
• Study Start: July 30, 2019
• Primary Completion: June 16, 2020
• Study Completion: March 16, 2021
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)