Clinical Assessment - HominisTM Surgical System | NCT04109989

Studies
Clinical Assessment - HominisTM Surgical System

NCT04109989

Sponsor

Memic Innovative Surgery

Status

Unknown status

Last Update Posted

Feb 24, 2021Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Hysterectomy

Interventions

HominisTM Surgical System

Countries

Belgium
Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 8, 2018Actual

Primary Completion Date

Dec 1, 2021Estimated

Completion Date

Dec 30, 2021Estimated

First Submitted Date

Sep 26, 2019

First Submission Date that Met QC Criteria

Sep 27, 2019

First Posted Date

Oct 1, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 23, 2021

Last Update Posted Date

Feb 24, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HominisTM Surgical System	Experimental	Gynecological surgical procedure will be performed with the HominisTM Surgical System	Device: HominisTM Surgical System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HominisTM Surgical System	Device	Trans-vaginal gynecological procedures	HominisTM Surgical System

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

The device is intended for Vaginal procedures

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided