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Active Not Recruiting
NCT04109989
Clinical Assessment - HominisTM Surgical System
Conditions: Hysterectomy
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 50
Sponsor: Memic Innovative Surgery
Location: Imelda Hospital Bonheiden
Summary
A clinical research study designed to assess the HominisTM Surgical System in gynecological procedures.
Eligibility Criteria
Inclusion Criteria:
1. Female above 18 years of age inclusive.
2. Able to provide written informed consent.
3. Eligible for Total Transvaginal Laparoscopic Hysterectomy with Salpingo-Oophorectomy or Transvaginal Laparoscopic Hysterectomy with Salpingectomy and have an appropriate indication to go through this surgery.
4. Willing to undergo laparoscopic transvaginal procedure by Memic HominisTM Surgical System.
5. Fit for robotic-assisted transvaginal surgery based on surgeon discretion.
6. Can undergo general anesthesia per anesthesiologist assessment.
Exclusion Criteria:
1. Women with anatomical hazard for laparoscopy and/or vaginal and/or pouch of Douglas access (such as diagnosis of Crohn's disease, active Pelvic inflammatory disease (PID), active diverticulitis, sever peritoneal adhesions, frozen pelvis, obliterated vagina or sever recto-vaginal endometriosis).
2. Women after pelvic radiation.
3. Women diagnosed with active intra-abdominal malignancy.
4. Women with general condition or illness incompatible for surgery.
5. Women who are pregnant.
6. Unwillingness or inability to follow the procedures outlined in the protocol.
Source: ClinicalTrials.gov (NCT04109989). StuddyBuddy aggregates publicly available trial information.