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New device may help surgeons see blood flow during Kids' heart surgery

NCT ID NCT07361523

Knowledge-focused Sponsor: Boston Children's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study will test a handheld device called IntraOx that uses light to measure oxygen levels in heart and liver tissue during complex heart surgery in children. The goal is to see if it can give surgeons useful information about blood flow without interfering with the operation. Fifty children over age 1 having heart surgery at Boston Children's Hospital will take part.

What this could mean

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

Active substance
IntraOx tissue oximeter (device)
What this could lead to
If successful, this device could give surgeons real-time data on heart and organ blood flow during surgery, potentially improving decisions and outcomes.
What could go wrong
This is a small, early-stage study with only 50 participants. The device is not yet approved for children, and the readings won't change how surgery is done—so direct benefit is not guaranteed.

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 50 people

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

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

Patients over 1 year of age undergoing congenital heart surgery at Boston Children's Hospital identified by the PI and the study coordinator to have concern for decreased myocardial and peripheral perfusion for any reason. This may include, but will not be limited to, patients with history of myocardial ischemia, surgical procedures on the coronary arteries or operating near the coronary arteries that may impact myocardial perfusion, surgical procedures that may impact systemic perfusion, patients with history of coronary artery disease, patients with history of angina, patients with history of rheumatic disease that may impact perfusion, and patients with previous history of poor ventricular function, arrhythmia, or other complications following cardiopulmonary bypass.

Ages

1 year and older

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: * Patients over 1 year of age undergoing congenital heart surgery at Boston Children's Hospital are all eligible for participation in this study. * All subjects undergoing congenital heart surgery at Boston Children's Hospital will be screened for inclusion in this study. Screening will prioritize identifying patients with concern for decreased myocardial and peripheral perfusion for any reason, as designated by Dr. Sitaram Emani's clinical judgement. * Eligibility will be reviewed in advance by screening upcoming surgical procedures. All patients over 1 year of age will be eligible for participation in this study and screened for inclusion. Any patient at risk for malperfusion during bypass (e.g. Fontans, biventricular repair, long cross-clamp times, etc.) will be identified ahead of time and prioritized for inclusion in the study. Exclusion Criteria: * Any records flagged for "research opt out." * Neonates and children undergoing surgery less than 1 year of age

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Conditions

The condition(s) this trial relates to.

congenital heart disease

As listed by the trial registrant

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

Congenital heart disease

How to take part

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  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

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More trials for these conditions

Other studies related to the condition(s) this trial covers.