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The purpose of the MIRA Surgical System Registry is to accumulate and evaluate real world evidence experience as part of post-market surveillance using the MIRA Surgical System.
The studies primary goals are to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical | Patients undergoing surgery with the MIRA Surgical System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use of the MIRA Surgical System during surgery | Device | Use of the MIRA Surgical System to perform robotically assisted colorectal surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Performance of MIRA Surgical System | Successful completion of the surgical procedure using the MIRA Surgical System without conversion to open surgery (Yes/No). | From time of procedure through completion of the surgical procedure |
| Device Safety | Incidence of Device related adverse events and Unanticipated Device Effects | From time of surgery using the MIRA Surgical System through 30 days following surgical procedure |
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Inclusion Criteria:
Exclusion Criteria:
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Patients indicated for minimally invasive surgery using the MIRA Surgical System.
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| Name | Affiliation | Role |
|---|---|---|
| Piet Hinoul, M.D. | Virtual Incision Corporation | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bryan Medical Center | Lincoln | Nebraska | 68512 | United States |
Study design is to evaluate cumulative database of all patients who have undergone surgery using the MIRA Surgical System.
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