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 @ 12:16 PM
Ignite Modification Date:
2025-12-24 @ 12:16 PM
NCT ID:
NCT00837161
Eligibility Criteria:
* INCLUSION CRITERIA:
1. Recommended for Total Abdominal Hysterectomy
2. Age between 18 and 59
3. Weight less than 140kg (or 310lbs)
4. Pre or peri menopausal with FSH less than 40 mIU/ml
5. Uterine size less than 24 weeks based on MRI and physical exam assessment
6. Symptom severity score greater than or equal to 50 by Spies Uterine Fibroid Questionnaire.
7. Cervical cytology no more severe than low grade SIL
8. History of uterine leiomyoma causing symptoms of bleeding, pressure, or pain, as defined by the ACOG practice bulletin (ACOG Practice Bulletin 1994):
9. Dominant intramural fibroid greater than or equal to 3 cm and less than or equal to 16 cm on imaging.
EXCLUSION CRITERIA:
1. Other pelvic disease (mass indicated by history or MR imaging such as endometriosis, ovarian tumor, acute or chronic pelvic inflammatory disease)
2. Desire for future pregnancy
3. Significant systemic disease even if controlled
4. Pregnant or Positive pregnancy test
5. Hematocrit less than 25%
6. Extensive scarring along anterior lower abdominal wall (greater than 50% of area) or scar tissue or surgical clips in the direct path of the HIFU beam
7. MRI or MRI contrast agent contraindicated
8. Unable to quantify or measure fibroids on MR exam including nonenhancing fibroids
9. Fibroid or uterine calcifications
10. Dominant fibroid is pedunculated or greater than 5 cm submucosal
11. Communication barrier
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
59 Years
Study:
NCT00837161
Study Brief:
Protocol Section:
NCT00837161