Fat Reduction and Muscle Toning of Thighs

Fat Burn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04599257
• Other study ID #: BTL-703_300
• Status: Completed
• Phase: N/A
• Start date: September 15, 2020
• Est. completion date: January 20, 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 a simultaneous application of high-intensity focused electromagnetic procedure and radiofrequency energy for changes in subcutaneous fat tissue and muscle toning of thighs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: January 20, 2022
• Est. primary completion date: June 24, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

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

• Fat Burn

Intervention

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.

Locations

Country	Name	City	State
United States	Brian M. Kinney M.D., Inc	Beverly Hills	California
United States	Center For SmartLipo & Plastic Surgery	Langhorne	Pennsylvania
United States	Yael Halaas, M.D., F.A.C.S.	New York	New York
United States	Art of Skin MD	Solana Beach	California

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	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	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
Secondary	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