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 @ 3:28 AM
Ignite Modification Date:
2025-12-25 @ 3:28 AM
NCT ID:
NCT03323905
Eligibility Criteria:
Inclusion Criteria:
1. MR-HFU device accessibility to fibroids that at least 50% of fibroid volume can be treated
2. Fibroids selected for treatment meet the following criteria
1. Total planned ablation volume of all fibroids should not exceed 500 ml AND
2. Completely non-enhancing fibroids should not be treated
3. Transformed SSS score \>= 40
4. Pre- or peri-menopausal, as indicated by clinical evaluation
5. Weight \< 140 kg or 310 lbs
6. Willing and able to attend all study visits
7. Willing and able to use reliable contraception methods
8. Uterine size \< 24 weeks
9. Cervical cell assessment by PAP: normal, LOW Grade SIL, Low risk HPV or ASCUS subtypes of cervical tissue
10. Waist circumference \<110cm or 43 inches
Exclusion Criteria:
1. Other Pelvic Disease (Other mass, endometriosis, ovarian tumor, acute pelvic disease, significant adenomyosis, prolonged bleeding requiring further evaluation as determined by patient's gynecologist)
2. Positive pregnancy test
3. Extensive scarring along anterior lower - abdominal wall (\>50% of area)
4. Surgical clips in the potential path of the HIFU beam
5. Tattoos in the potential path of the HIFU beam
6. MRI contraindicated
7. MRI contrast agent contraindicated (including renal insufficiency)
8. Calcification around or throughout uterine tissue that may affect treatment
9. Communication barrier
10. Fibroids not quantifiable on MRI (e.g., multi-fibroid cases where volume measurements are not feasible)
11. Pedunculated fibroids
12. Bowel loops int he ultrasound beam path
13. Patients with inability to tolerate prolonged prone position for up to 3 hours
14. Patient with unstable medical conditions
15. Patients with coagulopathy or under current anti-coagulation therapy
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03323905
Study Brief:
Protocol Section:
NCT03323905