Clinical Assessment - HominisTM Surgical System

Not Applicable

• Conditions: Hysterectomy
• Interventions: Device: HominisTM Surgical System

• Registration Number: NCT04109989
• Lead Sponsor: Memic Innovative Surgery

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-08
• Study First Submitted: 2019-09-26
• Study First Submitted QC: 2019-09-27
• Study First Posted: 2019-10-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-23
• Last Update Posted: 2021-02-24
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HominisTM Surgical System	HominisTM Surgical System	Gynecological surgical procedure will be performed with the HominisTM Surgical System

Primary Outcome Measures

Name	Time	Method
Rate of conversion	Intra Operative	Rate of conversion to open or laparoscopic approach

Secondary Outcome Measures

Name	Time	Method
Post-operative procedural outcomes	Six weeks post procedure	Re-operation rate
Intra-operative & post-operative procedural outcomes	Intra-operative & six weeks post procedure	Mortality
Intra-operative procedural outcomes	Intra-operative	Conversion rate (to laparotomy, laparoscopy, other ports used in addition to vaginal and umbilical port).
Vaginal tissue healing	Six weeks post procedure	Vaginal tissue healing will be assessed

Trial Locations

Locations (2)

Rambam Hospital; 🇮🇱 Haifa, Israel

Imelda Hospital; 🇧🇪 Bonheiden, Belgium