MRI Evaluation of Change in Gluteal Muscles Following the Treatment With HIFEM Device

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03815747

Enrollment

Registered

2019-01-24

Start date

2019-01-11

Completion date

2020-01-27

Last updated

2020-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscle Tone Increased

Brief summary

This study will use magnetic resonance imaging (MRI) to evaluate changes in gluteal muscle following the treatment with HIFEM stimulation for aesthetic improvement of buttocks.

Interventions

DEVICEHigh-Intensity Focused Electromagnetic (HIFEM) Field Device

The High-Intensity Focused Electromagnetic (HIFEM) Field device will be applied.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Age ≥ 21 years * 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 his/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 * Malignant tumor * Fever * Pregnancy * 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

Design outcomes

Primary

Measure	Time frame	Description
Effectiveness of the device for toning of buttocks according to MRI images	7 months	Evaluation of change in MRI images before and after the therapy procedure.

Secondary

Measure	Time frame	Description
Subject's satisfaction with study treatment	7 months	Subject's satisfaction with the therapy results evaluated through the Subject Satisfaction Questionnaire. The 7-point Likert scale Subject Satisfaction Questionnaire will be used for an analysis of the subject's opinion of the therapy results.
Side effects and adverse events (AE) associated with the study device	7 months	The occurrence of side effects and adverse events will be followed throughout the whole study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026