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:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 12:00 AM
NCT ID:
NCT02879058
Eligibility Criteria:
Inclusion Criteria:
1. Premenopausal and nonpregnant
2. Advised to undergo laparoscopic or robotic myomectomy by their provider
3. Documented imaging with transvaginal ultrasound or pelvic MRI within the past year, which accurately and within reason documents the location and number of leiomyomas present within the uterus
4. If deemed necessary by the provider, must have a pelvic MRI prior to surgery that states there are no concerning findings for malignancy
5. Must be eligible to undergo laparoscopic surgery and willing to present for clinic and imaging follow up during the 6 months following myomectomy
6. Must understand and voluntarily sign an informed consent form.
Exclusion Criteria:
1. Appearance of uterus concerning for malignancy on pelvic MRI
2. Current pregnancy
3. Any contraindication to laparoscopic or robotic surgery
4. Treatment with gonadotropin-releasing hormone (GnRH) analogs in the past 36 months
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
21 Years
Maximum Age:
45 Years
Study:
NCT02879058
Study Brief:
Protocol Section:
NCT02879058