Colon ProceduresNCT06856707
MIRA Registry Study: Post Market Surveillance Using the MIRA Surgical System
An observational study of Colon Procedures and Bowel Resection, run by Virtual Incision Corporation at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colon Procedures, Bowel Resection
- What is being tested?
- Use of the MIRA Surgical System during surgery
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2025to Jun 2028
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients indicated for minimally invasive surgery using the MIRA Surgical System.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
- Conditions
- Colon Procedures, Bowel Resection
- Being tested
- Use of the MIRA Surgical System during surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of the MIRA Surgical System during surgeryDevice
Also called Robotically Assisted Surgery
Use of the MIRA Surgical System to perform robotically assisted colorectal surgery.
| Study group | Role | What they receive |
|---|---|---|
| Surgical | Patients undergoing surgery with the MIRA Surgical System Receives: Device: Use of the MIRA Surgical System during surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of MIRA Surgical System
Successful completion of the surgical procedure using the MIRA Surgical System without conversion to open surgery (Yes/No).
Measured: From time of procedure through completion of the surgical procedure
Device Safety
Incidence of Device related adverse events and Unanticipated Device Effects
Measured: From time of surgery using the MIRA Surgical System through 30 days following surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start30 Apr 2025
- Primary completion28 May 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Virtual Incision Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Piet Hinoul, M.D., Study chair, Virtual Incision Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06856707
- Sponsor's protocol ID
- 110-002103
- Status last verified
- Sep 2026
- First submitted
- 26 Feb 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Study design is to evaluate cumulative database of all patients who have undergone surgery using the MIRA Surgical System.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MIRA Surgical System Registry Study (MIRA Registry)
- ClinicalTrials.gov ID
- NCT06856707
- Acronym / sponsor ID
- 110-002103
- Conditions
- Colon Procedures, Bowel Resection
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Virtual Incision CorporationIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 28 May 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical | – | Device: Use of the MIRA Surgical System during surgeryPatients undergoing surgery with the MIRA Surgical System |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients indicated for minimally invasive surgery using the MIRA Surgical System.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of the MIRA Surgical System during surgeryAlso: Robotically Assisted SurgeryUse of the MIRA Surgical System to perform robotically assisted colorectal surgery. | Device | Surgical |
Primary outcome
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).
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No. Study design is to evaluate cumulative database of all patients who have undergone surgery using the MIRA Surgical System.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Piet Hinoul, M.D. study chair
Virtual Incision Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Procedures and Bowel Resection, run by Virtual Incision Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of MIRA Surgical System (time frame: From time of procedure through completion of the surgical procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.