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 @ 11:00 AM
Ignite Modification Date:
2025-12-26 @ 11:00 AM
NCT ID:
NCT03725306
Eligibility Criteria:
Candidates for this study must meet ALL of the following criteria:
* Refractory menorrhagia with no organic cause
* Female subject from (and including) age 25 to 50 years
* Uterine sound measurement ≥6.0 cm to ≤ 10.0cm (external os to fundus).
* A minimum menstrual blood loss
* for subjects not using medical therapy, a Menstrual Pictogram(MP) score of ≥150 for two baseline cycles within three months prior to treatment OR
* MP score ≥150 for one month for women who either had
* at least 3 prior months documented failed medical therapy; or
* had a contraindication to medical therapy; or
* refused medical therapy
* Premenopausal at enrollment as determined by FSH measurement ≤ 40 IU/L
* Not pregnant and no desire to conceive at any time
* Subject agrees to use a reliable form of contraception. If a hormonal birth control method is used, the subject must have been on said method for ≥ 3 months prior to enrollment and agrees to remain on the same hormonal regimen through their study participation.
* Able to provide written informed consent using a form that has been approved by the reviewing IRB/EC
* Subject agrees to follow-up visits and data collection requirements
* Subject who is literate or demonstrates an understanding on how to use the Menstrual Pictogram (MP) diary 4.1.1. EXCLUSION CRITERIA
To be enrolled, candidates should NOT meet any exclusion criterion:
* Pregnancy or subject with a desire to become pregnant
* Endometrial hyperplasia as confirmed by histology
* Presence of active endometritis
* Active pelvic inflammatory disease
* Active sexually transmitted disease (STD), at the time of ablation.
o Note: Treatment of STD documented in the chart serves as sufficient evidence of infection resolution. Subject may be considered for study enrollment.
* Presence of bacteremia, sepsis, or other active systemic infection
* Active infection of the genitals, vagina, cervix, uterus or urinary tract at the time of the procedure
* Known/suspected gynecological malignancy within the past 5 years
* Known clotting defects or bleeding disorders
* Untreated/unevaluated cervical dysplasia (except CIN I)
* Known/suspected abdominal/pelvic cancer
* Prior uterine surgery (except low segment cesarean section) that interrupts the integrity of the uterine wall (e.g., myomectomy or classical cesarean section)
* Previous endometrial ablation procedure
* Currently on medications that could thin the myometrial muscle, such as long-term steroid use (except inhaler or nasal therapy for asthma)
* Currently on anticoagulants
* Abnormal or obstructed cavity as confirmed by transvaginal ultrasound +/- hysteroscopy - specifically:
1. Septate or bicornuate uterus or other congenital malformation of the uterine cavity
2. Submucosal fibroids (grade 0-2) which protrude \>1cm into the uterine cavity
3. Polyps \>2 cm in maximum diameter
4. Any intramural myoma \> 3 cm or which distorts the uterine cavity
* Presence of an intrauterine device (IUD) which the subject unwilling to have removed at the time of the operative visit
* Presence of an implanted contraceptive device (e.g. Essure or Adiana).
* Subject not currently on hormonal birth control therapy and unwilling to use a non-hormonal birth control post-ablation
* Subject wanting concomitant hysteroscopic sterilization
* Subject who is within 6-weeks post-partum
* Any general health condition which, in the opinion of the Investigator, could represent an increased risk for the subject
* Any subject who is currently participating in the primary endpoint phase of an on-going investigational drug or device study or intends future participation in any other research of an investigational drug or device during the primary endpoint phase of this study
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
25 Years
Maximum Age:
50 Years
Study:
NCT03725306
Study Brief:
Protocol Section:
NCT03725306