HIFEM for Arms, Lower Limbs, and Oblique Muscles

Muscle Tone Increased Clinical Trial

Official title:

Efficacy of HIFEM Treatments for Strengthening and Toning of Arms, Lower Limbs and Oblique Muscles

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04426526
• Other study ID #: BTL-799_600
• Status: Completed
• Phase: N/A
• Start date: May 8, 2019
• Est. completion date: December 8, 2020

Study information

• Verified date: January 2021
• Source: BTL Industries Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluation of HIFEM treatments for strengthening and toning of arms, lower limbs and oblique muscles.

Description:

This study will evaluate the clinical efficacy and safety of the high power magnet system for toning and strengthening of arm, lower limb and oblique muscles. The study is a prospective multi-center open-label four-arm study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 8, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Voluntarily signed informed consent form

• BMI = 30 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 effecting significant change in either direction during study participation

Exclusion Criteria:

• Cardiac pacemakers

• Implanted defibrillators, implanted neurostimulators

• Electronic implants

• Pulmonary insufficiency

• Metal implants

• Drug pumps

• Application in the head area

• Application in the heart area

• Malignant tumor

• Injured or otherwise impaired muscles

• Fever

• Pregnancy

• Sensitivity or allergy to latex

• Breastfeeding

• Following recent surgical procedures when muscle contraction may disrupt the healing process

• Application over areas of the skin which lack normal sensation

• Scars, open lesions and wounds at the treatment area

• Unrepaired abdominal hernia

• Patients after Cesarean section delivery

Related Conditions & MeSH terms

• Muscle Hypertonia
• Muscle Tone Increased

Intervention

Device:
• BTL 799-2
High power magnet system

Locations

Country	Name	City	State
United States	Plastic Surgical Associates	Fort Collins	Colorado
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	Changes in adipose and muscle tissue measured via ultrasound imaging	To determine the effectiveness of the device for strengthening and toning of arms, lower limbs and oblique muscles through changes in surrounding tissues, measured via ultrasound imaging. Using the obtained images, change in adipose and muscular tissues before and after the therapy sessions will be compared for every participant according to the study phase.	7 months
Secondary	Patient's satisfaction measured via questionnaires	To determine the patient's satisfaction with study treatment for non-invasive strengthening and toning of arms, lower limbs and oblique muscles.The 5-point Likert scale Satisfaction questionnaire will be used to evaluate the participant's satisfaction with the therapy outcome where the level of agreement between "strongly agree" and "strongly disagree" should indicate the participant's satisfaction with the therapy.	7 months
Secondary	Incidence Of Treatment-Related Adverse Events	To determine side effects and adverse events (AE) associated with the BTL 799-2 treatment of the arms, lower limbs and oblique muscles. Safety outcomes will include an evaluation of the treatment area to assess and evaluate the following: Muscle pain; Temporary muscle spasm; Temporary joint or tendon pain; Local erythema or skin redness	7 months