MIRA Registry Study

May 2, 2025 updated by: Virtual Incision Corporation

MIRA Surgical System Registry Study (MIRA Registry)

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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Lincoln, Nebraska, United States, 68512
        • Bryan Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients indicated for minimally invasive surgery using the MIRA Surgical System.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Surgical
Patients undergoing surgery with the MIRA Surgical System
Device: Use of the MIRA Surgical System during surgery
Use of the MIRA Surgical System to perform robotically assisted colorectal surgery.
Other Names:
  • Robotically Assisted Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance of MIRA Surgical System
Time Frame: 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).
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virtual Incision Corporation

Investigators

  • Study Chair: Piet Hinoul, M.D., Virtual Incision Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2025

Primary Completion (Estimated)

May 28, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

February 26, 2025

First Submitted That Met QC Criteria

February 26, 2025

First Posted (Actual)

March 4, 2025

Study Record Updates

Last Update Posted (Actual)

May 7, 2025

Last Update Submitted That Met QC Criteria

May 2, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 110-002103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Study design is to evaluate cumulative database of all patients who have undergone surgery using the MIRA Surgical System.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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