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 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT01064960
Eligibility Criteria:
Inclusion Criteria:
* Women, age between 18 and 59 years
* Weight \< 140kg
* Pre- or peri-menopausal
* Uterine size \< 24 weeks
* Transformed SSS score \> 40
* Normal Cervical cell assessment by PAP
* Symptomatic Fibroid disease
* Dominant fibroid greater than or equal to 3cm and less than or equal to 12 cm
Exclusion Criteria:
* Other Pelvic Disease
* Desire for future pregnancy
* Significant systemic disease even if controlled
* Positive pregnancy test
* Hematocrit \< 25%
* Scarring or other interference of the HIFU beam
* MRI or contrast contraindicated
* Fibroids not quantifiable on MRI
* Calcifications around or throughout uterine tissues
* Communication barrier
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
59 Years
Study:
NCT01064960
Study Brief:
Protocol Section:
NCT01064960