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 @ 9:24 PM
Ignite Modification Date:
2025-12-24 @ 9:24 PM
NCT ID:
NCT02035332
Eligibility Criteria:
Inclusion Criteria:
1. Refractory menorrhagia with no definable organic cause (abnormal uterine bleeding)
2. Female subject from age 35 to 50 years
3. Uterine sound measurement of 6.0cm to 10.0cm (external os to internal fundus)
4. A minimum PBLAC score of \>150 for 3 months prior to study enrollment; OR, A minimum PBLAC score \>150 for one month for women who either
1. had at least 3 prior months documented failed medical therapy; or
2. had a contraindication to medical therapy; or
3. refused medical therapy
5. Premenopausal at enrollment as determined by FSH measurement ≤ 40 IU/ml
6. Not pregnant and no desire to conceive at any time
7. Patient agrees not to use hormonal contraception or any other medical intervention for bleeding during the study
8. Able to provide written informed consent using a form that has been approved by the reviewing IRB/EC
9. Subject agrees to follow-up exams and data collection, including ability to accurately use menstrual diaries
10. Subject who is literate or demonstrates an understanding on how to use menstrual diaries
Exclusion Criteria:
1. Pregnancy or subject with a desire to conceive
2. Complex endometrial hyperplasia as confirmed by histology
3. Presence of active endometritis
4. Active pelvic inflammatory disease
5. Active sexually transmitted disease (STD)
6. Presence of bacteremia, sepsis, or other active systemic infection
7. Active infection of the genitals, vagina, cervix, uterus or urinary tract at the time of the procedure
8. Known/suspected gynecological malignancy within the past 5 years
9. Known clotting defects or bleeding disorders
10. Untreated/unevaluated cervical dysplasia
11. Known/suspected abdominal/pelvic cancer
12. Prior uterine surgery (except low segment cesarean section) that interrupts the integrity of the uterine wall (e.g., transmural myomectomy or classical cesarean section)
13. Previous endometrial ablation procedure
14. Currently on medications that could thin the myometrial muscle, such as long-term steroid use
15. Currently on anticoagulants
16. Abnormal or obstructed cavity as confirmed by hysteroscopy or SIS, specifically:
1. Septate or bicornuate uterus or other congenital malformation of the uterine cavity
2. Pedunculated or submucosal myomas distorting the uterine cavity
3. Polyps likely to be the cause of the subject's menorrhagia
4. Intramural or subserosal myomas that distort the uterine cavity
17. Presence of an intrauterine device (IUD)
18. Subject currently on hormonal birth control therapy or unwilling to use a non-hormonal birth control post-ablation.
19. Any general health condition which, in the opinion of the Investigator, could represent an increased risk for the subject
20. Any subject who is participating in any other research of an investigational drug or device that has not yet completed the primary endpoint evaluation.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
35 Years
Maximum Age:
50 Years
Study:
NCT02035332
Study Brief:
Protocol Section:
NCT02035332