Evaluate the Effect of Abdominal Electrical Muscle Stimulation on Abdominal Wall Restoration in Post - Partum Women
NCT ID: NCT03917160
Last Updated: 2021-11-24
Study Results
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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COMPLETED
NA
60 participants
INTERVENTIONAL
2019-03-27
2021-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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EMS treatment
Subjects will undergo treatment with EMS and measurements
EMS device
EMS treatment will be performed
Control
Subjects will undergo measurements only
No interventions assigned to this group
Interventions
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EMS device
EMS treatment will be performed
Eligibility Criteria
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Inclusion Criteria
* Informed Consent Form signed by the subject.
* BMI interval: 18.5 ≤ BMI ≤ 32 (normal to overweight, but not obese).
* Willing to follow the treatment and follow-up schedule and post-treatment care instructions.
* Willing to have photographs and images taken of the treated areas to be used de-identified in evaluations, publications and presentations.
* In addition, negative urine pregnancy test as tested before each treatment and at the last visit for women with childbearing potential (e.g. not menopause).
Exclusion Criteria
* Planning on moving away from the local area within 6 months
* History of other energy-based therapy within one year
* Diffuse pain syndrome or chronic pain requiring daily narcotics
* Active electrical implant/device in any region of the body, including pacemaker or internal defibrillator
* Permanent implant in the treated area such as metal plates, screws or silicon, metal piercing or other.
* Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles.
* Severe concurrent conditions, such as cardiac disorders, sensory disturbances, epilepsy, uncontrolled hypertension, and liver or kidney diseases.
* History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin.
* History of bleeding coagulopathies or use of anticoagulants except for low-dose aspirin.
* Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regimen.
* Impaired immune system due to immunosuppressive diseases such as AIDS and HIV or use of immunosuppressive medications.
* Pregnancy.
* Poorly controlled endocrine disorders, such as Diabetes, or thyroid dysfunction and hormonal virilization.
* Isotretinoin (Accutane) within last 6 months.
* Any active condition in the treatment area, such as sores, Psoriasis, eczema, and rash, open lacerations, abrasions or lesions, infection in the area to be treated, current urinary tract infection or pelvic infection, uterine prolapse, cystocele, rectocele.
* Any surgical procedure in the treatment area within the last 12 months or before complete healing.
* Having received treatment with light, laser, RF, or other devices in the treated area within 2-3 weeks for non-ablative procedures, and 6-12 weeks for ablative fractional laser resurfacing (according to treatment severity) prior to treatment, except special recommendations.
* Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g., ibuprofen-containing agents) one week before and after each treatment session, as per the practitioner's discretion.
* As per the practitioner's discretion, refrain from treating any condition which might make it unsafe for the patient.
* Any therapies or medications which may interfere with the use of the study device.
* Compromised health as determined by the study doctor.
18 Years
45 Years
FEMALE
No
Sponsors
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InMode MD Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Henri Ramirez, MD
Role: PRINCIPAL_INVESTIGATOR
Southern Oklahoma Women's Health 731 12th Ave NW Suite 201 Ardmore, OK 73401
Locations
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Southern Oklahoma Women's Health
Ardmore, Oklahoma, United States
Advanced Women's Care of the Lowcountry, PC
Bluffton, South Carolina, United States
Countries
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Other Identifiers
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DO608427A
Identifier Type: -
Identifier Source: org_study_id