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

InMode MD Ltd.2 sites in 1 country60 target enrollmentMarch 27, 2019

ConditionsAbdominal Wall Restoration Diastasis Recti

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Abdominal Wall Restoration
Sponsor: InMode MD Ltd.
Enrollment: 60
Locations: 2
Primary Endpoint: Change in inter-recti distance (IRD), measured via Magnetic Resonance Imaging.
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

March 27, 2019

End Date

October 1, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

InMode MD Ltd.

Responsible Party

Sponsor

Eligibility 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 ≤ 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

•- 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.

Outcomes

Primary Outcomes

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

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 Outcomes

Investigator satisfaction(1 Month, 3 Months, 6 Months)
Subject improvement and satisfaction(1 Month, 3 Months, 6 Months)
Change in Urogynecological Complaints measured using the Pelvic Floor Distress Inventory.(1 Month, 3 Months, 6 Months)
Change in Severity of Lumbopelvic and/or Abdominal Pain measured by Visual Analog Scale.(1 Month, 3 Months, 6 Months)