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:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
NCT ID:
NCT01735812
Eligibility Criteria:
Inclusion Criteria:
1. Pre-menopausal woman between the ages of 30 and 50 (inclusive)
2. Patient had completed her family planning and does not desire future childbearing.
3. Patient is suffering from menorrhagia as a result of symptomatic uterine fibroids.
4. Patient's uterus size is smaller than 18 gestational weeks.
5. Patient wishes to preserve her uterus and avoid hysterectomy.
6. Patient has 1-3 treatable uterine fibroids in size of up to 10cm measured by US/MRI.
7. Overall treated fibroid volume is ≤ 3,138cm3 (width x length x height x 0.523)
8. Patient has clinical menorrhagia as indicated by menstrual blood loss of ≥160 ml during one baseline cycle prior to treatment.
9. Patient is able to visit the clinic as needed during the 1 year follow-up period following the treatment.
10. The patient has been informed of the study and agrees to its provisions, and has signed an IRB approved written informed consent, including data privacy authorization.
Exclusion Criteria:
1. Patient had not finished her family planning
2. Patient was already treated for uterine fibroids in the past (UAE, myomectomy, HIFU,…) or undergone endometrial ablation.
3. Patient had been treated with GnRH over the last 3 months.
4. Patient has known symptomatic endometriosis that cannot be completely removed during laparoscopic procedure.
5. Patient has known or suspected adenomyosis
6. Patient had any active abdominal/pelvic inflammatory disease.
7. Patient has known or suspected gynecologic malignancy.
8. Patient with submucosal fibroids type "zero"
9. Patient with undiagnosed vaginal bleeding
10. Patient with blood clotting disorders
11. Patients carrying contagious diseases such as Tuberculosis Hepatitis or AIDS.
12. Patient participating in other trials using drugs or devices.
13. Patient is unable to commit all study requirements including follow-up visits and questionnaires.
14. Patient has any contraindication for laparoscopic surgery
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
30 Years
Maximum Age:
50 Years
Study:
NCT01735812
Study Brief:
Protocol Section:
NCT01735812