Fat Reduction and Muscle Toning of Thighs

Simultaneous Application of High-Intensity Focused Electromagnetic Procedure and Radiofrequency for Changes in Subcutaneous Fat Tissue and Muscle Toning of Thighs

This study will evaluate the clinical efficacy and safety of a simultaneous application of high-intensity focused electromagnetic procedure and radiofrequency energy for changes in subcutaneous fat tissue and muscle toning of thighs.

Study Overview

• Status: Completed
• Conditions: Fat Burn
• Intervention / Treatment: Device: BTL-899

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Beverly Hills, California, United States, 90212
      • Brian M. Kinney M.D., Inc
    • Solana Beach, California, United States, 92075
      • Art of Skin MD
  • New York
    • New York, New York, United States, 10022
      • Yael Halaas, M.D., F.A.C.S.
  • Pennsylvania
    • Langhorne, Pennsylvania, United States, 19047
      • Center For SmartLipo & Plastic Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Hip and thigh circumference changes; The subjects will be enrolled and assigned into a single study group. Subjects will be required to complete four (4) treatment visits and two to three follow-up visits. All of the study subjects will receive the treatment with the subject device. At the baseline visit, MRI imaging will be performed; the subject's weight and hip and thigh circumference will be recorded. Photos of the treated area will be taken. The treatment administration phase will consist of four (4) treatments, delivered once a week. The applicator of the device will be applied over the treatment area. The device will induce visible muscle contractions along with heating of the subcutaneous fat. At the last therapy visit, the subject's weight and hip and thigh circumference will be recorded, and photos of the treated area will be taken. In addition, subjects will receive Subject Satisfaction Questionnaire to fill in.

Device: BTL-899; The device applicator combines high-intensity focused electromagnetic procedure and radiofrequency energy to induce visible muscle contractions along with heating of the subcutaneous fat.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of structural changes of subcutaneous tissues between pre-treatment and post-treatment based on MRI imaging	The primary objective of the study is to determine the effectiveness of a simultaneous application of high-intensity focused electromagnetic procedure and radiofrequency energy for change in the adipose layer thickness between pre-treatment and post-treatment based on MRI imaging. The changes will be considered statistically significant where p-value <0.05.	7 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess safety profile by recording of adverse events	All AEs including local and systemic reactions not meeting the criteria for "serious adverse events" will be captured on the appropriate CRF. Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed only by those with the training and authority to make a diagnosis, which would include MD, DDS, DMD, PA, Nurse Practitioner or DO), and time of resolution/stabilization of the event. All AEs occurring during the study must be documented appropriately regardless of relationship to study device. All AEs will be followed to adequate resolution.	7 months
Assess subjects' satisfaction with the treatment using Subject Satisfaction Questionnaire	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 4-therapy related questions with answer "Strongly agree" will be the best possible answer and "Strongly disagree" the worst.	7 months

Collaborators and Investigators

• Sponsor: BTL Industries Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2020
• Primary Completion (Actual): June 24, 2021
• Study Completion (Actual): January 20, 2022

Study Registration Dates

• First Submitted: October 12, 2020
• First Submitted That Met QC Criteria: October 19, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): February 9, 2022
• Last Update Submitted That Met QC Criteria: February 8, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: muscle tone; muscle strengthening; fat reduction
• Other Study ID Numbers: BTL-703_300

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No