Back to resultsHIFEM for Arms, Lower Limbs, and Oblique Muscles
Primary Purpose
Muscle Tone Increased
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BTL 799-2
Sponsored by
About this trial
This is an interventional treatment trial for Muscle Tone Increased focused on measuring muscle strengthening, muscle tone
Eligibility Criteria
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
Sites / Locations
- Plastic Surgical Associates
- Juva Skin & Laser Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Biceps circumference reduction
Triceps circumference reduction
Lower limb circumference reduction
Oblique muscles toning
Arm Description
This arm will evaluate the clinical efficacy and safety of the high power magnet system for toning and strengthening of biceps brachii.
This arm will evaluate the clinical efficacy and safety of the high power magnet system for toning and strengthening of triceps brachii.
This arm will evaluate the clinical efficacy and safety of the high power magnet system for toning and strengthening of muscles in lower limbs.
This arm will evaluate the clinical efficacy and safety of the high power magnet system for toning and strengthening of oblique muscles.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04426526
Brief Title
HIFEM for Arms, Lower Limbs, and Oblique Muscles
Official Title
Efficacy of HIFEM Treatments for Strengthening and Toning of Arms, Lower Limbs and Oblique Muscles
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
May 8, 2019 (Actual)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
December 8, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BTL Industries Ltd.
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluation of HIFEM treatments for strengthening and toning of arms, lower limbs and oblique muscles.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Tone Increased
Keywords
muscle strengthening, muscle tone
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Biceps circumference reduction
Arm Type
Experimental
Arm Description
This arm will evaluate the clinical efficacy and safety of the high power magnet system for toning and strengthening of biceps brachii.
Arm Title
Triceps circumference reduction
Arm Type
Experimental
Arm Description
This arm will evaluate the clinical efficacy and safety of the high power magnet system for toning and strengthening of triceps brachii.
Arm Title
Lower limb circumference reduction
Arm Type
Experimental
Arm 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.
Arm Title
Oblique muscles toning
Arm Type
Experimental
Arm Description
This arm will evaluate the clinical efficacy and safety of the high power magnet system for toning and strengthening of oblique muscles.
Intervention Type
Device
Intervention Name(s)
BTL 799-2
Intervention Description
High power magnet system
Primary Outcome Measure Information:
Title
Changes in adipose and muscle tissue measured via ultrasound imaging
Description
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.
Time Frame
7 months
Secondary Outcome Measure Information:
Title
Patient's satisfaction measured via questionnaires
Description
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.
Time Frame
7 months
Title
Incidence Of Treatment-Related Adverse Events
Description
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
Time Frame
7 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Plastic Surgical Associates
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80525
Country
United States
Facility Name
Juva Skin & Laser Center
City
New York
State/Province
New York
ZIP/Postal Code
11377
Country
United States
12. IPD Sharing Statement
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HIFEM for Arms, Lower Limbs, and Oblique Muscles
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