Presented by Maria Bizecki-Porcellato
Thank you. I’m very proud to be here. I am a, a Croatian, born in Canada, so I’m very, I’m very happy to be presenting today. I want to talk about a study, that was looking at the, GIMA or gastrointestinal electric activity and its, accuracy in helping to, detect the absence or presence ofendometriosis.
This is done with an EVG medical device, electroviscerogram, it’s also known as the ENDOSURE test. So let’s just briefly review the results.
There were 340 randomly selected women in this prospective study from two sites. 54 of them failed to meet the inclusion criteria, so the 286 were left. We knew that 233 of them had presence of endometriosis with positive biopsy.
53 of them had absence of endometriosis. Mean age was 38 years.
The sensitivity that was found was 95%. The specificity was 86% with a diagnostic accuracy of 92%.
So the indications for use were to diagnose or exclude disease for post therapeutic evaluation, adolescent screening, pelvic pain clinics, tour like disease, fertility clinics, and also for pre pregnancy screening.
I wanted to show a quick example of the report that is generated once the study is completed with the Endo Ure test, so, on the left hand side of the slide you will see that there is a normal result take note of the red lines that is indicating the baseline. The blue lines are indicating the post water load, and on the vertical side of the graph.
You can see the time on the horizontal. There is a frequency of the GIMA. Energy or activity in cycles per minute. On the right side of the slide, you will see that this is someone who was positive for endometriosis. It’s very easily visualized by the peaks that you see in the blue and the arrows, the red arrows are pointing the frequencies out that are the very specific fingerprint that this biomarker is looking for to detect.
How Does the ENDOSURE test work?
Its mechanism of action, it’s actually quite simple. Endometriosis, tissue or lesions will produce prostaglandins. These neurotransmitters then move through the circulatory system that go into the smooth muscle of the small bowel. And this results in seizure-like spasms that produce abnormal small bowel myoelectrical activity that is unique to endometriosis and then is detected by the endo shirt test.
To briefly just talk about the procedure, how does this work? It’s quite simple. Women just come in fasting for six to eight hours prior to the test. We put on electrical abdominal leads. They get a respiratory belt that is attached and after taking a brief baseline, we get them to drink a water load.
The water load is what initiates the movement in the small bowel. They then rest in a reclining position for 30 minutes and the ENDOSURE test will detect, measure and report the GIMA activity and it’s as simple as that. And the report is generated and we have an immediate diagnosis.
It takes 30 minutes. It’s a non-invasive procedure. Thank you.
Tier 1 ENDOSURE Test Abstract Presentation
