Bowel Resection, Colon Procedures
Conditions
Brief summary
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: * To evaluate the performance of the MIRA Surgical System * To evaluate the Device Safety profile
Interventions
DEVICEUse of the MIRA Surgical System during surgery
Use of the MIRA Surgical System to perform robotically assisted colorectal surgery.
Sponsors
Virtual Incision Corporation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients undergoing surgery using the MIRA Surgical System * Subject is able to provide informed consent * Subject is available for post operative follow up visit through 30 days
Exclusion criteria
* Has or is participating in another clinical trial which may confound study results * In the opinion of the investigator, patient is not likely to complete post-operative care and/or return for standard follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance of MIRA Surgical System | From time of procedure through completion of the surgical procedure | Successful completion of the surgical procedure using the MIRA Surgical System without conversion to open surgery (Yes/No). |
| Device Safety | From time of surgery using the MIRA Surgical System through 30 days following surgical procedure | Incidence of Device related adverse events and Unanticipated Device Effects |
Countries
United States
Outcome results
None listed