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:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
NCT ID:
NCT04231812
Eligibility Criteria:
Inclusion Criteria:
1. Female patients indicated for elective surgery requiring laparoscopic hysterectomy, myomectomy where either manual morcellation or power morcellation is needed for tissue removal at which a morcellator for cutting and extraction of tissue is required.
2. Pre- menopausal woman patient age 18-50 years
3. Mass measured with diameter up to 10 cm to be removed
4. Normal Pap test result within the last 24 months prior to enrollment
5. Normal and /or Non-Clinically Significant as per investigator discretion CBC and Blood chemistry test within at least 6 months prior to surgery.
6. Signed an informed consent
Exclusion Criteria:
1. Emergency cases
2. Abdominal wall thickness is greater than 10 cm according to US measurements.
3. Patient requires procedure involving the ovaries (e.g., Oophorectomy, Salpingo)
4. Patient is defined as a "high risk" patient for developing cancer (per standard assessment, including but not limited to imaging)
5. Suspicion of malignant or pre-malignant tissue according to preoperative assessment including US exam within 30 days prior to surgery
6. Known or suspected gynecologic malignancy within the past five years
7. Pacemaker, internal defibrillator/cardio converter
8. Previous extensive pelvic surgery or any other medical procedure which in the investigator's judgment contraindicates the patient's participation
9. Contraindications to anesthesia or abdominal surgery. ASA score above 3
10. Concurrent participation in any other clinical study
11. Active infection at the time of the procedure.
12. BMI\<20 or BMI\>40
13. Known history or presence of any medical disorder, which in the investigator's judgment contraindicates the patient's participation (e.g., Known and documented active liver disease, renal failure, cognitive disorder, cardiopulmonary disease, impaired coagulation parameters, etc.)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT04231812
Study Brief:
Protocol Section:
NCT04231812