NCT05523284: SPGENDO

Combining Ultrasound and Biomarkers to Diagnose Superficial Endometriosis

ENROLLING BY INVITATION Last updated 12 February 2026

What this trial tests

trial testing SonoPODography in Endometriosis (Diagnosis) in 50 participants. Enrolling by invitation.

Timeline

15 November 2023

Primary endpoint
30 December 2026

30 December 2026

Quick facts

Lead sponsor	McMaster University
Status	ENROLLING BY INVITATION
Study type	OBSERVATIONAL
Enrollment	50
Start date	15 November 2023
Primary completion	30 December 2026
Estimated completion	30 December 2026
Sites	1 location across Canada

Drugs / interventions tested

• SonoPODography

Conditions studied

• Endometriosis (Diagnosis) — all drugs for Endometriosis (Diagnosis) →
• Endometriosis — all drugs for Endometriosis →

Sponsor

McMaster University

Who can join

18 and older, female only, with Endometriosis (Diagnosis) or Endometriosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.