HIFEM for Arms, Lower Limbs, and Oblique Muscles

BTL

Status: Completed

Conditions: Muscle Tone Increased

Treatments: Device: BTL 799-2

Study type: Interventional

Funder types: Industry

Identifiers

NCT04426526

BTL-799_600

Details and patient eligibility

About

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

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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23 participants in 4 patient groups

Biceps circumference reduction

Experimental group

Description:

This arm will evaluate the clinical efficacy and safety of the high power magnet system for toning and strengthening of biceps brachii.

Treatment:

Device: BTL 799-2

Triceps circumference reduction

Experimental group

Description:

This arm will evaluate the clinical efficacy and safety of the high power magnet system for toning and strengthening of triceps brachii.

Treatment:

Device: BTL 799-2

Lower limb circumference reduction

Experimental group

Description:

This arm will evaluate the clinical efficacy and safety of the high power magnet system for toning and strengthening of muscles in lower limbs.

Treatment:

Device: BTL 799-2

Oblique muscles toning

Experimental group

Description:

This arm will evaluate the clinical efficacy and safety of the high power magnet system for toning and strengthening of oblique muscles.

Treatment:

Device: BTL 799-2