Enrolling by invitation NCT06856707
MIRA Registry Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Use of the MIRA Surgical System during surgery.
- Who it may be relevant to
- Registry conditions: Colon Procedures, Bowel Resection. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
MIRA Surgical System Registry Study (MIRA Registry)
Overview
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
- Device Use of the MIRA Surgical System during surgery
Use of the MIRA Surgical System to perform robotically assisted colorectal surgery.
Primary outcome measures
- Performance of MIRA Surgical System [Time frame: From time of procedure through completion of the surgical procedure]
- Device Safety [Time frame: From time of surgery using the MIRA Surgical System through 30 days following surgical procedure]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- Bryan Medical Center — Lincoln
Identifiers
NCT: NCT06856707 · 110-002103