Abdominal Wall RestorationNCT03917160

Evaluate the Effect of Abdominal Electrical Muscle Stimulation on Abdominal Wall Restoration in Post - Partum Women

A study testing EMS device in people with Abdominal Wall Restoration and Diastasis Recti, run by InMode MD Ltd. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 to 45 years, women only
Conditions the study is for: Abdominal Wall Restoration, Diastasis Recti
What is being tested?: EMS device
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 2 sitesUnited States
Study dates: 27 Mar 2019to 1 Oct 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Women only
No healthy volunteers
Adult

Who may be able to join

- 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).

Who cannot join

- 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.

Show all 22Show fewer

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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Southern Oklahoma Women's Health
Ardmore, Oklahoma, 73401
Advanced Women's Care of the Lowcountry, PC
Bluffton, South Carolina, 29910

Other trials in United States

About this study

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

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

Conditions: Abdominal Wall Restoration, Diastasis Recti
Being tested: EMS device

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EMS deviceDevice
EMS treatment will be performed

Study groups in NCT03917160
Study group	Role	What they receive
EMS treatment	Experimental	Subjects will undergo treatment with EMS and measurements Receives: Device: EMS device
Control	No intervention	Subjects will undergo measurements only

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in inter-recti distance (IRD), measured via Magnetic Resonance Imaging.
Up to 5 subjects will undergo MRI to evaluate effect of the treatment
Measured: 1 month
Change in inter-recti distance (IRD), measured via UltraSound Imaging to evaluate effect of the treatment
Measured: 1 Month, 3 Months, 6 Months

Secondary outcomes (4)

Change in Urogynecological Complaints measured using the Pelvic Floor Distress Inventory.
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.
Measured: 1 Month, 3 Months, 6 Months
Change in Severity of Lumbopelvic and/or Abdominal Pain measured by Visual Analog Scale.
Pain will be assessed based on the Numerical Scale Response (NSR).
Measured: 1 Month, 3 Months, 6 Months
Investigator satisfaction
Satisfaction assessment will be performed by the study investigator using using 0 - 4 -points Likert scale
Measured: 1 Month, 3 Months, 6 Months
Subject improvement and satisfaction
Improvement and satisfaction assessment will be performed independently by the subject using 0 - 4 -points Likert scale
Measured: 1 Month, 3 Months, 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Mar 20191 Oct 2021

First posted16 Apr 2019
Study start27 Mar 2019
Primary completion1 Oct 2021
Study completion1 Oct 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Abdominal Wall RestorationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03917160
Sponsor's protocol ID: DO608427A
Status last verified: Oct 2021
First submitted: 12 Apr 2019
Last updated: 24 Nov 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Study at a glance

From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03917160
Acronym / sponsor ID: DO608427A
Conditions: Abdominal Wall Restoration, Diastasis Recti
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: InMode MD Ltd.Industry (pharma, biotech, devices)
Study start: 27 Mar 2019 (actual)
Primary completion: 1 Oct 2021 (actual)
Study completion: 1 Oct 2021 (actual)
First posted: 16 Apr 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
EMS treatment	Experimental	Device: EMS deviceSubjects will undergo treatment with EMS and measurements
Control	No intervention	–Subjects will undergo measurements only

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

- 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.

Key exclusion criteria (22 listed)

- 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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EMS deviceEMS treatment will be performed	Device	EMS treatment

Primary outcome

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

4 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Henri Ramirez, MD principal investigator

Southern Oklahoma Women's Health 731 12th Ave NW Suite 201 Ardmore, OK 73401

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing EMS device in people with Abdominal Wall Restoration and Diastasis Recti, run by InMode MD Ltd. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in inter-recti distance (IRD), measured via Magnetic Resonance Imaging. (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03917160.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2021.