Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT06521060
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent
* Age ≥ 18 years
* Women indicated for uterus-preserving surgery (tumour resection) or hysterectomy for myometrial lesion ('myoma-like' uterine tumour(s))
* USG finding of atypical myometrial lesion/s a
Exclusion Criteria:
patient 's refusal
* age \< 18 years
* ongoing pregnancy
* inability to perform TCB /contraindications for TCB (trombocytopenia, coagulopathy, PID, colpitis) or definitive surgery (myomectomy or hysterectomy)
* USG finding of more than 2 atypical lesion/s with a diameter ≤ 20 mm and ≥ 100 mm
* inability to perform any of the 3 core needle biopsy approaches (transvervical, trans uterine cavity, transvaginal) because of anatomical, localization issues. The percutaneous transabdominal biopsy is not allowed
* Polymyomatous uterus that may not be examined adequately with routine transvaginal ultrasound
* myoma (which would be subject to TCB) type 7 according to FIGO classification 16
* history of conservative hormonal therapy less than 3 months prior to study enrolment
* history of conservative therapy via uterine artery embolisation or laparoscopic uterine artery occlusion
* history of pregnancy less than one year prior to study enrollment
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06521060
Study Brief:
Protocol Section:
NCT06521060