Last updated: February 23, 2021
Sponsor: Memic Innovative Surgery
Overall Status: Active - Recruiting
Phase
N/A
Condition
N/ATreatment
N/AClinical Study ID
NCT04109989
MEMIC-5083
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Female above 18 years of age inclusive.
- Able to provide written informed consent.
- Eligible for Total Transvaginal Laparoscopic Hysterectomy with Salpingo-Oophorectomyor Transvaginal Laparoscopic Hysterectomy with Salpingectomy and have an appropriateindication to go through this surgery.
- Willing to undergo laparoscopic transvaginal procedure by Memic HominisTM SurgicalSystem.
- Fit for robotic-assisted transvaginal surgery based on surgeon discretion.
- Can undergo general anesthesia per anesthesiologist assessment.
Exclusion
Exclusion Criteria:
- Women with anatomical hazard for laparoscopy and/or vaginal and/or pouch of Douglasaccess (such as diagnosis of Crohn's disease, active Pelvic inflammatory disease (PID), active diverticulitis, sever peritoneal adhesions, frozen pelvis, obliteratedvagina 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.
Study Design
Total Participants: 50
Study Start date:
November 08, 2018
Estimated Completion Date:
December 30, 2021
Connect with a study center
Imelda Hospital
Bonheiden,
BelgiumActive - Recruiting
Rambam Hospital
Haifa, 3109601
IsraelActive - Recruiting
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