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:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2025-12-24 @ 10:14 PM
NCT ID:
NCT06692335
Eligibility Criteria:
Inclusion Criteria:
* Age 18 - 50 years-old
* Pre or peri menopausal with FSH less than 25 mIU/ml
* BMI \< 33 kg/m2 or abdominal wall thickness \< 5 cm
* Uterine size ≤18 weeks based on physical exam assessment
* Dominant intramural fibroid ≥ 3cm and ≤ 10cm on imaging
* Symptomatic fibroids cause menorrhagia, pressure, or pelvic pain
* Willing and able to give informed consent
Exclusion Criteria:
* Patient with other pelvic mass indicated by history or magnetic resonance imaging (MRI) such as endometriosis, abnormal adnexal mass, ovarian tumor, acute or chronic pelvic inflammatory disease
* Morbid obesity
* Inability to lie in a prone position for more than 2 hours
* Extensive abdominal scar on the acoustic channel
* Women with pregnancy, lactation or menopause
* Uterine premalignant or malignant pathologies or pathology other than uterine fibroid cannot be ruled out through detailed clinical assessment and investigation including MRI
* Rapid growth of fibroids, defined as a doubling in size in 6 months
* History of or current thromboembolic event (deep vein thrombosis, pulmonary embolus, stroke)
* Coagulation problem or using medication which affect clotting function
* History of pelvic irradiation
* Pedunculated submucosal or subserosal fibroid of size ≧5cm and with a stalk less than 25% of the maximal fibroid diameter
* Cervical/ broad ligament fibroid
* Contraindication to MRI due to severe claustrophobia or implanted metallic device.
* Co-existing adenomyosis
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT06692335
Study Brief:
Protocol Section:
NCT06692335