MIRA Registry Study

NCT06856707 | Enrolling By Invitation FDA Device

• 1 other identifier: 110-002103
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Colon Procedures; Bowel Resection

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Surgical

Patients undergoing surgery with the MIRA Surgical System

Device: Use of the MIRA Surgical System during surgery

Interventions

Use of the MIRA Surgical System during surgery DEVICE

Use of the MIRA Surgical System to perform robotically assisted colorectal surgery.

Also known as: Robotically Assisted Surgery

Surgical

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Virtual Incision Corporation: lead

Study Sites (1)

Bryan Medical Center

Lincoln, Nebraska, 68512, United States

Location

Study Officials

• Piet Hinoul, M.D.

  Virtual Incision Corporation

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 4, 2025
• Study Start: April 30, 2025
• Primary Completion (Estimated): May 28, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)