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 @ 11:50 PM
Ignite Modification Date:
2025-12-24 @ 11:50 PM
NCT ID:
NCT05955651
Eligibility Criteria:
Inclusion Criteria:
1. Women undergoing minimally invasive Laparoscopic / Robotic hysterectomy for presumably benign conditions such as (fibroids, adenomyosis, endometriosis, pelvic organ prolapse, abnormal uterine bleeding)
2. Large size uterus measuring more than 10 cm on US requiring cold knife morcellation within the Alexis containment bag, surgery will be done by designated surgeon at UTMB from 08/01/2023 to 08/01/2024.
3. Women 18 years and older
4. Subjects must be able to provide consents.
5. Normal endometrial biopsy.
6. Normal cervical cancer screening
Exclusion Criteria:
1. Known Gynecological malignancy.
2. Endometrial biopsy with endometrial intraepithelial hyperplasia.
3. History of exposure to pelvic radiation
4. Post-menopausal patients
5. Emergency hysterectomy
6. TDC patients
7. Patient less than 18 years old
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05955651
Study Brief:
Protocol Section:
NCT05955651