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:
NCT01285960
Eligibility Criteria:
Inclusion Criteria:
1. Patient age 18 or older
2. Patients who present with symptomatic uterine fibroids and are not seeking treatment for the reason of improving fertility.
3. Patients who have given written informed consent
4. Patients who are able and willing to attend all study visits
5. Patients who are pre or peri-menopausal (within 12 months of last menstrual period)
6. Patients should have completed child bearing
7. Able to communicate sensations during the ExAblate procedure.
8. Uterine fibroids, which are device accessible (i.e., positioned in the uterus such that they can be accessed without being shielded by bowel or bone).
9. Fibroid(s) clearly visible on non-contrast MRI.
Exclusion Criteria:
1. Pregnant patients, as confirmed by serum/urine test at time of screening, or urine pregnancy test on the day of treatment. Pregnancies following ExAblate treatment could be dangerous for both mother and fetus.
2. Uterine size \>24 weeks.
3. Patients with pedunculated fibroids
4. Patients with active pelvic inflammatory disease (PID).
5. Patients with active local or systemic infection
6. Patients experiencing any symptoms of lower extremity neuropathy, including chronic leg or lower back pain, within the last 6 months
7. Contraindication for MRI Scan:
* Severe claustrophobia that would prevent completion of procedure in the MR unit
* Metallic implants that are incompatible with MRI
* Sensitivity to MRI contrast agents
* Any other contraindication for MRI Scan
8. Extensive abdominal scarring in the beam path (that cannot be avoided by redirection of the beam)
9. Dermoid cyst of the ovary anywhere in the treatment path.
10. Known or suspected pelvic carcinoma or pre-malignant conditions, including sarcoma and adenomatous hyperplasia.
11. Intrauterine device (IUD) anywhere in the treatment path
12. Undiagnosed vaginal bleeding
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT01285960
Study Brief:
Protocol Section:
NCT01285960