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ENROLLING BY INVITATION
NCT05523284

Combining Ultrasound and Biomarkers to Diagnose Superficial Endometriosis

Sponsor: McMaster University

View on ClinicalTrials.gov

Summary

Endometriosis is a benign gynecological disease characterized by uterine-like cells growing outside the uterus, leading to pain, infertility, and inflammation. Endometriosis most commonly occurs in the forms of Superficial Endometriosis (SE), Deep Endometriosis and Ovarian Endometriosis (Endometrioma) (OE). Ultrasound diagnosis of DE and OE has become more reliable with advances in ultrasound technology, technique and expertise, leading to decreased diagnosis time for patients and allowing for better optimization of surgeries if required. SE, however, lacks any reliable non-invasive diagnosis methods. SE is the most common form of endometriosis and is defined as a disease that lines the peritoneum and is small and superficial in nature, leading to chronic inflammation, infertility, and pain. SE is difficult to visualize on ultrasound due to its size and alignment with tissue, requiring fluid to expand the pelvis and partially suspend these small lesions, allowing them to be diagnosed through ultrasound. Leonardi et al. observed that in some patients, a physiologic change occurs whereby fluid fills the pouch of Douglas (POD), allowing increased visualizing during ultrasound. This led to the development of Saline-infused sonoPODgraphy (SPG), a novel method utilizing modified commonly used ultrasound techniques called saline-infusion sonohysterography (SIS) and hysterosalpingo-contrast-sonography (HyCoSy), to reliably visualize the POD (Leonardi et al, 2019). Visualizing the POD is important as SE is often deposited in the POD. This diagnostic accuracy pilot study aims to pioneer the technique whereby SPG will be evaluated as a novel, rapid, non-invasive diagnostic tool for SE. The injected fluid from the POD will be withdrawn and evaluated for novel biomarkers, allowing us to further develop rapid diagnostics and better understand disease mechanisms. We hypothesize that SPG will allow for the diagnosis of SE with a diagnostic accuracy parallel to the current invasive gold standard, laparoscopy.

Official title: Transvaginal Ultrasound-guided Culdocentesis for Peritoneal Fluid Cytokines in Patients With Possible Superficial Endometriosis But no Ultrasound-diagnosed Ovarian or Deep Endometriosis (SPG)

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

50

Start Date

2023-11-15

Completion Date

2026-12-30

Last Updated

2026-02-12

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

SonoPODography

SonoPODography (SPG) is a novel ultrasound-guided technique whereby saline is injected through the cervix and flushed into the POD, creating an acoustic window for diagnosing superficial endometriosis.

Locations (1)

McMaster University

Hamilton, Ontario, Canada