Status:
UNKNOWN
Clinical Assessment - HominisTM Surgical System
Lead Sponsor:
Memic Innovative Surgery
Conditions:
Hysterectomy
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
A clinical research study designed to assess the HominisTM Surgical System in gynecological procedures.
Eligibility Criteria
Inclusion
- Female above 18 years of age inclusive.
- Able to provide written informed consent.
- 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.
- Willing to undergo laparoscopic transvaginal procedure by Memic HominisTM Surgical System.
- Fit for robotic-assisted transvaginal surgery based on surgeon discretion.
- Can undergo general anesthesia per anesthesiologist assessment.
Exclusion
- 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).
- Women after pelvic radiation.
- Women diagnosed with active intra-abdominal malignancy.
- Women with general condition or illness incompatible for surgery.
- Women who are pregnant.
- Unwillingness or inability to follow the procedures outlined in the protocol.
Key Trial Info
Start Date :
November 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04109989
Start Date
November 8 2018
End Date
December 30 2021
Last Update
February 24 2021
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Imelda Hospital
Bonheiden, Belgium
2
Rambam Hospital
Haifa, Israel, 3109601