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Clinical Trials/NCT04665414
NCT04665414
Completed
Not Applicable

Value of Transvaginal Ultrasound, Transvaginal Sonographic Elastography and MRI for the Diagnosis of Adenomyosis

University Hospital Muenster1 site in 1 country103 target enrollmentSeptember 29, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Endometriosis
Sponsor
University Hospital Muenster
Enrollment
103
Locations
1
Primary Endpoint
specificity MRI
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
September 29, 2017
End Date
January 31, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
University Hospital Muenster
Responsible Party
Principal Investigator
Principal Investigator

Dr. med. Sebastian Daniel Schäfer

Head of Gynecology

University Hospital Muenster

Eligibility Criteria

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
  • cannot give informed consent
  • no hysterectomy planned

Outcomes

Primary Outcomes

specificity MRI

Time Frame: through study completion, an average of 1 year

specificity MRI

sensitivity transvaginal ultrasound

Time Frame: through study completion, an average of 1 year

sensitivity transvaginal ultrasound

specificity transvaginal ultrasound elastography

Time Frame: through study completion, an average of 1 year

specificity transvaginal ultrasound elastography

sensitivity intraoperative ENZIAN FA

Time Frame: through study completion, an average of 1 year

sensitivity intraoperative ENZIAN FA

sensitivity MRI

Time Frame: through study completion, an average of 1 year

sensitivity MRI

specificity transvaginal ultrasound

Time Frame: through study completion, an average of 1 year

specificity transvaginal ultrasound

sensitivity transvaginal ultrasound elastography

Time Frame: through study completion, an average of 1 year

sensitivity transvaginal ultrasound elastography

specificity intraoperative ENZIAN FA

Time Frame: through study completion, an average of 1 year

specificity intraoperative ENZIAN FA

Secondary Outcomes

  • sensitivity and specificity of single sonographic or MRI criteria or combinations thereof(through study completion, an average of 1 year)

Study Sites (1)

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