AP-HP, Bicêtre Hospital
Le Kremlin-Bicêtre, 94275, France
NCT Number: NCT04554602
The aim of the study is evaluate the fusion ultrasound performance compared to MRI and coelioscopy diagnosis when a surgical intervention is performed.
This study is active but is not currently recruiting participants.
Notify Me18 year–50 year
Female
Observational
Le Kremlin-Bicêtre, 94275, France
The research is about diagnosis performance between fusion ultrasound and the gold standard (MRI coelioscopy ). Fusion ultrasound is a no-invasive scientific technical which allow with security to evaluate the progress of endometriosis lesions. During 39 months, 200 patients will be follow. In one arm, there is the control group with women without endometriosis. In the second arm, there is the patient with endometriosis. We will compare monitoring differences between gold standard and fusion ultrasound ( Cost assessment,exams duration, reproductibility, the link between symptoms and evolution of the lesion size).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Fusion ultrasound is a technique that allows a volume acquired in MRI to be coupled to an ultrasound scan with real-time image synchronisation.
Time frame: 3 years and 3 months
To evaluate the diagnostic performance of fusion ultrasound compared to transvaginal gynaecological ultrasound and MRI for the diagnosis of endometriosis lesions.
Time frame: 3 years and 3 months
Evaluation of the reproducibility by an intra-class correlation test for the conclusions of fusion ultrasound between two operators.
Time frame: 3 years and 3 months
Correlation between the evolution of clinical and quality of life symptoms (EHP30 form and Short Form 36) and the evolution of lesion size between initial MRI and follow-up ultrasounds at 6 months and one year
Time frame: 3 years and 3 months
Comparison of the average examination time by a Student T-test between standard and fusion ultrasound.
Time frame: 3 years and 3 months
Comparison of imaging costs will be carried out over 3 years between a conventional procedure with annual MRI and the procedure being evaluated
Assistance Publique - Hôpitaux de Paris
Other
Fusion Ultrasound for Diagnosis and Monitoring of Endometriosis Lesions ENDOFUSION
Acronym: ENDOFUSION
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