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 @ 1:50 PM
Ignite Modification Date:
2025-12-24 @ 1:50 PM
NCT ID:
NCT07289295
Eligibility Criteria:
Inclusion Criteria:
1. Female, aged 22 years or above, who provided written informed consent to participate in the study.
2. Patient deemed suitable for minimally invasive total hysterectomy and/or Salpingo-Oophorectomy, for benign condition.
3. Patient with BMI ≤40.
Exclusion Criteria:
1. Patient unwilling to provide informed consent.
2. Medical contraindication for general anaesthesia or minimally invasive procedure.
3. Oncological cases, patient undergoing surgery or treatment for malignant disease.
4. Clinically assessed Uterus size of \> 14 pregnancy weeks (Estimated as \> 14-15 cm longitudinal diameter).
5. Patient participation in an interventional clinical study that could impact primary outcomes results.
6. Patient who falls into American Society of Anaesthesiologists (ASA) Class IV or above (Appendix A).
7. Uncontrolled hypertension, uncontrolled diabetes mellitus, or kidney failure.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
22 Years
Study:
NCT07289295
Study Brief:
Protocol Section:
NCT07289295