Clinical Assessment - HominisTM Surgical System

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

Study Overview

• Status: Recruiting
• Conditions: Hysterectomy
• Intervention / Treatment: Device: HominisTM Surgical System

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Limor Kuznits, B.Sc; Phone Number: +972-54-630-20-12; Email: Limor@memicmed.com

Study Locations

• Belgium
  • Bonheiden, Belgium
    • Recruiting
    • Imelda Hospital
    • Contact: Jan Baekelandt, Dr; Phone Number: +32 499 47 1371; Email: Jan.Baekelandt@imelda.be
• Israel
  • Haifa, Israel, 3109601
    • Recruiting
    • Rambam Hospital
    • Contact: Omer Mor, Dr.; Phone Number: 054-648-6414; Email: omermor23@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HominisTM Surgical System; Gynecological surgical procedure will be performed with the HominisTM Surgical System	Device: HominisTM Surgical System; Trans-vaginal gynecological procedures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of conversion	Rate of conversion to open or laparoscopic approach	Intra Operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intra-operative & post-operative procedural outcomes	Intra-operative & post-operative complications	Intra-operative and six weeks post procedure
Intra-operative & post-operative procedural outcomes	adverse events (AE and SAE)	Intra-operative & six weeks post procedure
Intra-operative & post-operative procedural outcomes	Bladder injury rate	Intra-operative & six weeks post procedure
Intra-operative & post-operative procedural outcomes	Rectal injury rate	Intra-operative & six weeks post procedure
Intra-operative procedural outcomes	Operative time	Intra-operative
Intra-operative & post-operative procedural outcomes	Transfusion rate	Intra-operative & six weeks post procedure
Intra-operative procedural outcomes	Conversion rate (to laparotomy, laparoscopy, other ports used in addition to vaginal and umbilical port).	Intra-operative
Intra-operative & post-operative procedural outcomes	Mortality	Intra-operative & six weeks post procedure
Post-operative procedural outcomes	Length of hospital stay	Six weeks post procedure
Post-operative procedural outcomes	Re-admission rate	Six weeks post procedure
Post-operative procedural outcomes	Re-operation rate	Six weeks post procedure
Vaginal tissue healing	Vaginal tissue healing will be assessed	Six weeks post procedure

Collaborators and Investigators

• Sponsor: Memic Innovative Surgery

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2018
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 30, 2021

Study Registration Dates

• First Submitted: September 26, 2019
• First Submitted That Met QC Criteria: September 27, 2019
• First Posted (Actual): October 1, 2019

Study Record Updates

• Last Update Posted (Actual): February 24, 2021
• Last Update Submitted That Met QC Criteria: February 23, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: MEMIC-5083

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No