inclusion/exclusioN criteria

Is this an original or revised submission?

Original

Revised

Name of the Person Entering Data into this CRF

First Name

Last Name

1) Patient is able to provide informed consent and sign the IRB-approved informed consent form.

Yes

No

2) Patient is pre-menopausal and 30-50 years of age at the time of enrollment.

Yes

No

3) Patient is not actively attempting to become pregnant for a minimum of 1 year after UFE, or practicing abstinence and willing to continue for a minimum of 1 year after UFE, or is surgically sterile.

Yes

No

4) Patient is suffering from clinically significant symptoms attributed to the presence of uterine fibroids including abnormal menstrual bleeding and/or bulk-related symptoms including pelvic pain/discomfort, abdominal distension, urinary symptoms (including but not limited to increased urinary frequency or urinary hesitancy), and/or dyspareunia.

Yes

No

5) Patient has a history of pelvic malignancy

Yes

No

6) Patient is pregnant or intends to become pregnant within 12 months of the planned UFE procedure.

Yes

No

7) Patient has had an abnormal PAP smear (anything other than normal or ASCUS – Atypical Squamous Cells of Unknown Significance) within 12 months of the planned UFE procedure.

Yes

No

8) Patient has a coexisting condition that might explain the presenting symptoms (including but not limited to adenomyosis, endometrial hyperplasia, endometriosis, and complex ovarian cysts).

Yes

No

9) Patient has evidence of current or recent pelvic inflammatory disease or uterine infection

Yes

No

10) Patient has another serious medical condition that might preclude full participation in the study to the desired endpoint (e.g., uncontrolled diabetes mellitus, malignancy, COPD, MI, CHF, etc.)

Yes

No

11) Patient has a severe contrast allergy or renal insufficiency that would represent a contraindication to the administration of iodine-based or gadolinium-based contrast agents.

Yes

No

12) Patient has a contraindication to MRI

Yes

No

13) Patient has one or more MRI findings including a uterine size >20 cm in greatest length, a dominant fibroid with a greatest diameter >12 cm, an intracavitary submucosal fibroid, or non-enhancing dominant fibroids.

Yes

No

14) In the judgment of the investigator, the patient is unable or unlikely to be able to comply with the study procedures and requirements.

Yes

No

15) Patient is unable or unwilling to sign the informed consent to allow participation in the study

Yes

No

Attestation *

I approve the data entered into this CRF and attest to its accuracy.

Date of Completion

MM

DD

YYYY