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 @ 4:01 PM
Ignite Modification Date:
2025-12-24 @ 4:01 PM
NCT ID:
NCT04434066
Eligibility Criteria:
Inclusion Criteria:
* All benign total laparoscopic hysterectomy and/or robotic-assisted hysterectomy, +/- unilateral salpingo-oophorectomy or bilateral salpingo-oophorectomy
* Adnexectomy, cystectomy, tubal procedures at time of hysterectomy
* Age \>18 years old
* Uterus \>12 weeks, or \>250 grams (based on imaging), or requiring morcellation based on clinical judgment at time of pre-operative enrollment
* English and Spanish speaking
Exclusion Criteria:
* Pre-malignant conditions (i.e. endometrial intraepithelial neoplasia, high-grade cervical intraepithelial neoplasia), known gynecologic malignancy, and any contraindications to abdominal or vaginal morcellation
* Planned concurrent procedures (i.e. hernia repair, bowel resections, anti-incontinence procedures, prolapse repair, and mastectomy)
* Appendectomy for endometriosis is not excluded
* No chronic pain disorders requiring medical management (endometriosis can be included)
* Planned abdominal hysterectomy or vaginal hysterectomy candidates
* Conversion to laparotomy or inability to complete morcellation
* Contraindications to laparoscopy
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT04434066
Study Brief:
Protocol Section:
NCT04434066