NCT04426526

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 8, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2020

Completed
Last Updated

January 13, 2021

Status Verified

January 1, 2021

Enrollment Period

12 months

First QC Date

May 22, 2020

Last Update Submit

January 12, 2021

Conditions

Muscle Tone Increased

Keywords

muscle strengtheningmuscle tone

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Patient's satisfaction measured via questionnaires

    7 months

  • Incidence Of Treatment-Related Adverse Events

    7 months

Study Arms (4)

Biceps circumference reduction

EXPERIMENTAL

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

Device: BTL 799-2

Triceps circumference reduction

EXPERIMENTAL

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

Device: BTL 799-2

Lower limb circumference reduction

EXPERIMENTAL

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

Device: BTL 799-2

Oblique muscles toning

EXPERIMENTAL

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

Device: BTL 799-2

Interventions

BTL 799-2DEVICE

High power magnet system

Biceps circumference reductionLower limb circumference reductionOblique muscles toningTriceps circumference reduction

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Plastic Surgical Associates

Fort Collins, Colorado, 80525, United States

Location

Juva Skin & Laser Center

New York, New York, 11377, United States

Location

MeSH Terms

Conditions

Muscle Hypertonia

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2020

First Posted

June 11, 2020

Study Start

May 8, 2019

Primary Completion

April 30, 2020

Study Completion

December 8, 2020

Last Updated

January 13, 2021

Record last verified: 2021-01

Locations

US(2)