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| Name | Class |
|---|---|
| Division of General Oncologic and Minimally Invasive Surgery, Niguarda Hospital Milan | UNKNOWN |
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The objective of this clinical trial is to evaluate the safety and efficacy of Versius in Inguinal Hernia repair surgery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery with Versius | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Versius Surgical System | Device | Modular robotic system intended to assist in the accurate control of its surgical endoscopic instruments across a range of surgical procedures. |
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| Measure | Description | Time Frame |
|---|---|---|
| Success rate | Rate of successful completion of robotic assisted surgery as planned without unplanned conversion to other laparoscopic or open surgery | Up to completion of surgery |
| Serious Adverse Event rate | Rate of total procedure related serious adverse events | Up to 30 days post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Operative time | Surgical time from skin incision to skin closure | Up to completion of surgery |
| Estimated blood loss | Amount of blood estimated to be lost during surgery (in mL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mark Slack, MD | Contact | +44 7766 024389 | mark.slack@cmrsurgical.com | |
| Chad Schaber, PhD | Contact | chad.schaber@cmrsurgical.com |
| Name | Affiliation | Role |
|---|---|---|
| Bruno Domenico Antonio Alampi, MD | Division of General Oncologic and Minimally Invasive Surgery, Niguarda Hospital Milan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of General Oncologic and Minimally Invasive Surgery, Niguarda Hospital Milan | Milan | Italy |
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| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Up to completion of surgery |
| Intra-operative adverse events | Adverse events that occur during surgery | Up to completion of surgery |
| Blood transfusion | Need for blood transfusion during surgery as well as amount transfused | Up to completion of surgery |
| Device deficiencies | Any device deficiencies of Versius during surgery | Up to completion of surgery |
| Reoperation within 24 hours | Need for reoperation after initial surgery | 24 hours post-surgery |
| Length of hospital stay | Hospital stay in days from day of surgery until discharge | Up to post-surgical discharge, i.e. the date when patient is considered sufficiently recovered from surgery to leave hospital, expected to be at most up to 1 month after date of surgery, typically within a few days |
| Adverse events | Rate of adverse events | Up to 30 days post-surgery |
| Readmission | Hospital readmission after post-surgical discharge | Up to 30 days post-surgery |
| Reoperation within 30 days | Need for reoperation as a result of interventional surgery itself or the indication for surgery | Up to 30 days post-surgery |
| Mortality rate | Up to 30 days post-surgery |