Clinical Assessment - HominisTM Surgical System

Last updated: February 23, 2021
Sponsor: Memic Innovative Surgery
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04109989
MEMIC-5083
  • Ages > 18
  • Female

Study Summary

A clinical research study designed to assess the HominisTM Surgical System in gynecological procedures.

Eligibility Criteria

Inclusion

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-Oophorectomyor Transvaginal Laparoscopic Hysterectomy with Salpingectomy and have an appropriateindication to go through this surgery.
  4. Willing to undergo laparoscopic transvaginal procedure by Memic HominisTM SurgicalSystem.
  5. Fit for robotic-assisted transvaginal surgery based on surgeon discretion.
  6. Can undergo general anesthesia per anesthesiologist assessment.

Exclusion

Exclusion Criteria:

  1. 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).
  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.

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,
    Belgium

    Active - Recruiting

  • Rambam Hospital

    Haifa, 3109601
    Israel

    Active - Recruiting

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