Clinical Assessment - HominisTM Surgical System

Hysterectomy Clinical Trial

Official title:

Clinical Assessment - HominisTM Surgical System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04109989
• Other study ID #: MEMIC-5083
• Status: Recruiting
• Phase: N/A
• Start date: November 8, 2018
• Est. completion date: December 30, 2021

Study information

• Verified date: February 2021
• Source: Memic Innovative Surgery
• Contact: Limor Kuznits, B.Sc
• Phone: +972-54-630-20-12
• Email: Limor[@]memicmed.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 30, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hysterectomy

Intervention

Device:
• HominisTM Surgical System
Trans-vaginal gynecological procedures

Locations

Country	Name	City	State
Belgium	Imelda Hospital	Bonheiden
Israel	Rambam Hospital	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Memic Innovative Surgery

Countries where clinical trial is conducted

Belgium,  Israel, 

Outcome

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