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Trial to Evaluate the Effect of Abdominal EMS (Electrical Muscle Stimulation) on AWR (Abdominal Wall Restoration) in Post - Partum Women

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ClinicalTrials.gov Identifier: NCT03917160
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
InMode MD Ltd.

Brief Summary:
The objective of the study is to evaluate the safety and efficacy of Abdominal EMS (Electrical Muscle Stimulation) on AWR (Abdominal Wall Restoration) in Post - Partum Women

Condition or disease Intervention/treatment Phase
Abdominal Wall Restoration Diastasis Recti Device: EMS device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial to Evaluate the Effect of Abdominal EMS (Electrical Muscle Stimulation) on AWR (Abdominal Wall Restoration) in Post - Partum Women
Actual Study Start Date : March 27, 2019
Estimated Primary Completion Date : March 11, 2020
Estimated Study Completion Date : March 11, 2020

Arm Intervention/treatment
Experimental: EMS treatment
Subjects will undergo treatment with EMS and measurements
Device: EMS device
EMS treatment will be performed

No Intervention: Control
Subjects will undergo measurements only



Primary Outcome Measures :
  1. Change in inter-recti distance (IRD), measured via Magnetic Resonance Imaging. [ Time Frame: 1 month ]
    Up to 5 subjects will undergo MRI to evaluate effect of the treatment

  2. Change in inter-recti distance (IRD), measured via UltraSound Imaging to evaluate effect of the treatment [ Time Frame: 1 Month, 3 Months, 6 Months ]

Secondary Outcome Measures :
  1. Change in Urogynecological Complaints measured using the Pelvic Floor Distress Inventory. [ Time Frame: 1 Month, 3 Months, 6 Months ]
    Pelvic Floor Distress Inventory - The PFDI-20 is both a symptom inventory and a measure of the degree of bother and distress (quality-of-life) caused by pelvic floor symptoms.

  2. Change in Severity of Lumbopelvic and/or Abdominal Pain measured by Visual Analog Scale. [ Time Frame: 1 Month, 3 Months, 6 Months ]
    Pain will be assessed based on the Numerical Scale Response (NSR).

  3. Investigator satisfaction [ Time Frame: 1 Month, 3 Months, 6 Months ]
    Satisfaction assessment will be performed by the study investigator using using 0 - 4 -points Likert scale

  4. Subject improvement and satisfaction [ Time Frame: 1 Month, 3 Months, 6 Months ]
    Improvement and satisfaction assessment will be performed independently by the subject using 0 - 4 -points Likert scale



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Postpartum women
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • - Post-partum women aged 18-45 years with symptoms of diastasis recti and weakness of the linea alba
  • Informed Consent Form signed by the subject.
  • BMI interval: 18.5 ≤ BMI ≤ 30 (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:

  • - Unable to commit to future appointments
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03917160


Contacts
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Contact: Janet Handley +1.949.305.0106 janeth@inmodemd.com

Locations
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United States, Oklahoma
Southern Oklahoma Women's Health Recruiting
Ardmore, Oklahoma, United States, 73401
Contact: Cari    580-224-9000      
Sponsors and Collaborators
InMode MD Ltd.
Investigators
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Principal Investigator: Henri Ramirez, MD Southern Oklahoma Women's Health 731 12th Ave NW Suite 201 Ardmore, OK 73401

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Responsible Party: InMode MD Ltd.
ClinicalTrials.gov Identifier: NCT03917160     History of Changes
Other Study ID Numbers: DO608427A
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No