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 @ 2:07 AM
Ignite Modification Date:
2025-12-25 @ 2:07 AM
NCT ID:
NCT01971060
Eligibility Criteria:
Inclusion Criteria:
Premenopausal female ages 18-42 At least one fibroid 3 cm or greater requiring at least one uterine incision Preparing to undergo Laparoscopic myomectomy
Exclusion Criteria:
Post-menopausal or Pregnant
* Endometriosis involving the uterus
* Adhesions to the uterus found at the time of initial laparoscopy
* History of /Current cancer , except basal cell
* Surgery Contraindications, including cardiac or other major system issue
* Greater than 5 fibroids
* The patient has ever been treated with uterine artery embolization of the myoma or magnetic resonance imaging (MRI) or other guided ultrasonification of myoma(s).
* The patient has any medical condition that might interfere with the safety of surgery and the second look laparoscopy, such as active intra-abdominal infection or abscess
* BMI \> 34
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
42 Years
Study:
NCT01971060
Study Brief:
Protocol Section:
NCT01971060