MedTrace Logo

Prospective Validation of the DEVA Algorithm for the Prediction of Severe Endometriosis

NCT05691322 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 276

Last updated 2023-01-20

No results posted yet for this study

Summary

Endometriosis is a chronic disease affecting 1 in 10 women. Its diagnosis is difficult and the time between the first symptoms and diagnosis is of about 7 years. diagnosis requires specialized imaging performed by referral practitioners for this pathology. According to current recommendations, non-specialized pelvic ultrasound is the recommended first-line examination. However, only reference ultrasound, performed by a doctor specialized in the disease and carried out according to a specific protocol (such as UBESS), is sufficiently reliable for diagnosis. The number of practitioners performing this type of examination is very low in France, which in practice results in a very low reliability of this strategy in real life. Pelvic MRI is also a much more reliable examination, available for review. However its access is limited. In addition, the false positive rate can be as high as 20%, particularly for minor forms of the disease.

The DEVA algorithm has been developed for the identification of women with endometriosis based on a self-administered pelvic pain symptom questionnaire (ENDOPAIN). In a preliminary study, this algorithm seems reliable for identify patients at high risk of this disease and would thus allow to triage patients requiring patients requiring an immediate MRI in order to shorten diagnostic delays. External validation of the algorithm is therefore necessary before clinical use. The main objective od this study is the prospective external validation of the diagnostic reliability of the DEVA algorithm used for the detection of women with endometriosis (visible on MRI or transvaginal ultrasound).

Conditions

  • Endometriosis

Interventions

DIAGNOSTIC_TEST

transvaginal ultrasound

Transvaginal ultrasound for endometriosis diagnosis (UBESS)

DIAGNOSTIC_TEST

MRI

MRI for endometriosis diagnosis (Enzian classification)

Sponsors & Collaborators

  • One Clinic

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-19
Primary Completion
2023-10-19
Completion
2024-01-19

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05691322 on ClinicalTrials.gov