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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04665414
Other study ID # Schäfer_Adenomyosis
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 29, 2017
Est. completion date January 31, 2021

Study information

Verified date April 2021
Source University Hospital Muenster
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

comparison of transvaginal ultrasound, transvaginal ultrasound elastography and MRI for the diagnosis of adenomyosis in patients receiving hysterectomy afterwards


Recruitment information / eligibility

Status Completed
Enrollment 103
Est. completion date January 31, 2021
Est. primary completion date January 1, 2021
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - dysmenorrhea - dyspareunia - non cyclic lower abdominal pain - hypermenorrhea - menometrorrhaghia - pain while compressing the Uterus during gyn exam - Patient wants to participate - Patient will receive hysterectomy Exclusion Criteria: - Patient declines to participate - contraindications against MRI - contraindications against ultrasound - minor - cannot give informed consent - no hysterectomy planned

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
MRI
preoperative MRI
transvaginal ultrasound
preoperative transvaginal ultrasound
transvaginal ultrasound elastography
preoperative transvaginal ultrasound elastography

Locations

Country Name City State
Germany University Hospital Muenster Münster NRW

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Muenster

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary sensitivity MRI sensitivity MRI through study completion, an average of 1 year
Primary specificity MRI specificity MRI through study completion, an average of 1 year
Primary sensitivity transvaginal ultrasound sensitivity transvaginal ultrasound through study completion, an average of 1 year
Primary specificity transvaginal ultrasound specificity transvaginal ultrasound through study completion, an average of 1 year
Primary sensitivity transvaginal ultrasound elastography sensitivity transvaginal ultrasound elastography through study completion, an average of 1 year
Primary specificity transvaginal ultrasound elastography specificity transvaginal ultrasound elastography through study completion, an average of 1 year
Primary sensitivity intraoperative ENZIAN FA sensitivity intraoperative ENZIAN FA through study completion, an average of 1 year
Primary specificity intraoperative ENZIAN FA specificity intraoperative ENZIAN FA through study completion, an average of 1 year
Secondary sensitivity and specificity of single sonographic or MRI criteria or combinations thereof sensitivity and specificity of single sonographic or MRI criteria or combinations thereof through study completion, an average of 1 year
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