NCT04109989

Brief Summary

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

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 8, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 1, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

February 24, 2021

Status Verified

February 1, 2021

Enrollment Period

3.1 years

First QC Date

September 26, 2019

Last Update Submit

February 23, 2021

Conditions

Hysterectomy

Outcome Measures

Primary Outcomes (1)

  • Rate of conversion

    Rate of conversion to open or laparoscopic approach

    Intra Operative

Secondary Outcomes (12)

  • Intra-operative & post-operative procedural outcomes

    Intra-operative and six weeks post procedure

  • Intra-operative & post-operative procedural outcomes

    Intra-operative & six weeks post procedure

  • Intra-operative & post-operative procedural outcomes

    Intra-operative & six weeks post procedure

  • Intra-operative & post-operative procedural outcomes

    Intra-operative & six weeks post procedure

  • Intra-operative procedural outcomes

    Intra-operative

  • +7 more secondary outcomes

Study Arms (1)

HominisTM Surgical System

EXPERIMENTAL

Gynecological surgical procedure will be performed with the HominisTM Surgical System

Device: HominisTM Surgical System

Interventions

HominisTM Surgical SystemDEVICE

Trans-vaginal gynecological procedures

HominisTM Surgical System

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe device is intended for Vaginal procedures
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female above 18 years of age inclusive.
  • Able to provide written informed consent.
  • 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.
  • Willing to undergo laparoscopic transvaginal procedure by Memic HominisTM Surgical System.
  • Fit for robotic-assisted transvaginal surgery based on surgeon discretion.
  • Can undergo general anesthesia per anesthesiologist assessment.

You may not qualify if:

  • 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).
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Imelda Hospital

Bonheiden, Belgium

RECRUITING

Rambam Hospital

Haifa, 3109601, Israel

RECRUITING

Central Study Contacts

Limor Kuznits, B.Sc

CONTACT

+972-54-630-20-12Limor@memicmed.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2019

First Posted

October 1, 2019

Study Start

November 8, 2018

Primary Completion

December 1, 2021

Study Completion

December 30, 2021

Last Updated

February 24, 2021

Record last verified: 2021-02

Locations

IL(1)BE(1)