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NCT05691322: ValDEVA
Prospective Validation of the DEVA Algorithm for the Prediction of Severe Endometriosis
trial testing transvaginal ultrasound in Endometriosis in 276 participants. Status unknown.
19 October 2023
Quick facts
| Lead sponsor | One Clinic |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 276 |
| Start date | 19 October 2022 |
| Primary completion | 19 October 2023 |
| Estimated completion | 19 January 2024 |
| Sites | 1 location across France |
Drugs / interventions tested
- transvaginal ultrasound
- MRI — full drug profile →
Conditions studied
- Endometriosis — all drugs for Endometriosis →
Sponsor
One Clinic
Who can join
Adults 18 to 45, female only, with Endometriosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05691322
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Related trials
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Other recruiting trials for Endometriosis
Currently open trials in the same condition.
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- NCT07240883 — ENDO1000 - A UK-wide Endometriosis Research Project · recruiting
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Other One Clinic trials
Trials by the same sponsor.
- NCT04820582 — Defining a Standard Set of Value-Based Patient-Centered Outcomes for Endometriosis · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05691322 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by One Clinic
- Last refreshed: 20 January 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05691322.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing