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 @ 3:55 AM
Ignite Modification Date:
2025-12-25 @ 3:55 AM
NCT ID:
NCT01632202
Eligibility Criteria:
Inclusion Criteria:
* Reproductive aged women: Age 18-48 years old
* Non-pregnant
* Otherwise healthy
* Regular menstrual cycle
* Documented submucosal myomas (one or more)
* Undergoing hysteroscopic myomectomy
* Patients must have signed an informed consent.
Exclusion Criteria:
* Age \< 18 or in menopause
* Undergoing a second uterine surgical procedure
* Other significant uterine pathology (including but not limited to adhesions, septae, or cancerous lesions)
* Hysteroscopic evidence of synechiae at the time of the procedure
* Surgeries complicated by excessive bleeding; defined by estimated blood loss \> 100cc given that the presence of excessive bleeding may predispose a patient to the formation of intrauterine adhesions
* Surgeries complicated by uterine perforation
* Surgeries complicated by postoperative intrauterine infection given that infection may predispose a patient to the formation of intrauterine adhesions (If these patients received Seprafilm Slurry, they will continue to be followed for safety monitoring)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
48 Years
Study:
NCT01632202
Study Brief:
Protocol Section:
NCT01632202