Clinical Assessment - HominisTM Surgical System

Study Overview
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Brief Summary
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A clinical research study designed to assess the HominisTM Surgical System in gynecological procedures.

Official Title
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Clinical Assessment - HominisTM Surgical System

Conditions
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Hysterectomy

Intervention / Treatment
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* Device: HominisTM Surgical System


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |