Last updated: July 25, 2023
Sponsor: Universitaire Ziekenhuizen KU Leuven
Overall Status: Active - Recruiting
Phase
N/A
Condition
Ovarian Cysts
Treatment
Ultrasound
Clinical Study ID
NCT05974618
S66455
Ages 18-50 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- • Consecutive patients with non-physiological adnexal masses or physiological cystsmeasuring 5cm or more in largest dimension;
- In case of more than one mass seen, only most suspicious mass to be included ORin case of two similar masses, the one with the largest dimension or most easilyaccessible with ultrasound;
- Previously recruited patient presenting with a different mass in subsequentpregnancy;
- Age 18 years and above.
Exclusion
Exclusion Criteria:
- • Cysts deemed to be clearly physiological WHEN smaller than 5 cm (largest diameter);
- Non-adnexal masses, e.g. peritoneal inclusion cysts (when diagnosis is certain)and peritoneal carcinomatosis with no adnexal mass;
- The denial or withdrawal of written informed consent;
- Same cyst already recruited for p-IOTA in a previous pregnancy.
- Age < 18 years
Study Design
Total Participants: 1000
Treatment Group(s): 1
Primary Treatment: Ultrasound
Phase:
Study Start date:
June 05, 2023
Estimated Completion Date:
July 31, 2026
Study Description
Connect with a study center
UZ Leuven
Leuven, Vlaams-Brabant 3000
BelgiumActive - Recruiting
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