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A window into the heart: new monitor may track oxygen in real time during pediatric surgery

NCT ID NCT07785141

Knowledge-focused Sponsor: Spectrocor Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 25, 2026 · Last updated Aug 28, 2026 · Updated 3 times

Summary

This observational study tests whether a new device, the SpectroCor Tissue Oxygenation Monitor, can accurately track oxygen levels in the heart muscle of children undergoing open-heart surgery. The device uses a sensor placed on the heart to measure oxygen availability during key surgical steps, such as when blood flow is temporarily stopped. The study aims to see if the device's readings correlate with surgical procedures and clinical parameters, and to assess its safety and usability. No comparison group is included, and participants are followed until hospital discharge.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SpectroCor Tissue Oxygenation Monitor and SpectroCor Sensor (a device that measures oxygen levels in heart tissue during surgery)
What this could lead to
If successful, this could provide a real-time tool for surgeons to monitor heart oxygenation during pediatric heart surgery, potentially improving surgical safety and outcomes.
What could go wrong
This is a small, early observational study, so the device may not reliably detect oxygenation changes in all cases. There is also a risk of device-related adverse events, though the study will monitor for these.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Feb 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Pediatric patient scheduled for an open-heart operation.

Ages

1 year to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Scheduled for open-heart surgery. * Age \<18 * Signed informed consent Exclusion Criteria: • Inability to provide informed consent

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Conditions

The condition(s) this trial relates to.

congenital heart disease ischemia reperfusion injury myocardial ischemia Myocardial Reperfusion Injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart defects, congenital Myocardial ischemia Reperfusion injury, myocardial

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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