HIFEM for Arms, Lower Limbs, and Oblique Muscles

NCT ID: NCT04426526

Last Updated: 2021-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-08

Study Completion Date

2020-12-08

Brief Summary

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

Detailed Description

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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.

Conditions

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Muscle Tone Increased

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Biceps circumference reduction

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

Group Type EXPERIMENTAL

BTL 799-2

Intervention Type DEVICE

High power magnet system

Triceps circumference reduction

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

Group Type EXPERIMENTAL

BTL 799-2

Intervention Type DEVICE

High power magnet system

Lower limb circumference reduction

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

Group Type EXPERIMENTAL

BTL 799-2

Intervention Type DEVICE

High power magnet system

Oblique muscles toning

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

Group Type EXPERIMENTAL

BTL 799-2

Intervention Type DEVICE

High power magnet system

Interventions

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BTL 799-2

High power magnet system

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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BTL Industries Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Plastic Surgical Associates

Fort Collins, Colorado, United States

Site Status

Juva Skin & Laser Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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BTL-799_600

Identifier Type: -

Identifier Source: org_study_id

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