High-Intensity Focused Electromagnetic (HIFEM) Field Device in Women After Childbirth

NCT ID: NCT03758690

Last Updated: 2020-05-27

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

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-25

Study Completion Date

2020-01-02

Brief Summary

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Evaluation of use of the High-Intensity Focused Electromagnetic (HIFEM) Field Device in women after childbirth.

Detailed Description

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Conditions

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Muscle Tone Increased

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment Group

Treatment with the investigational device - High-Intensity Focused Electromagnetic (HIFEM) Field Device

Group Type EXPERIMENTAL

High-Intensity Focused Electromagnetic (HIFEM) Field Device

Intervention Type DEVICE

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

Interventions

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High-Intensity Focused Electromagnetic (HIFEM) Field Device

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Non-breastfeeding women 3-36 months after childbirth
* 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
* 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
* Patients after Cesarean section delivery
Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

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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Skin Care Physicians of Georgia

Macon, Georgia, United States

Site Status

Chicago Cosmetic Surgery and Dermatology

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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BTL-After Childbirth

Identifier Type: -

Identifier Source: org_study_id

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