Spectroscopic Assessment of Myocardial Oxygenation Changes in Pediatric Heart Surgery
- Myocardial Ischemia
- Heart Defects, Congenital
- Reperfusion Injury, Myocardial
At a glance
- Phase
- Phase not stated
- Study type
- Observational
- Sponsor
- Spectrocor
- Enrolment target
- 30
- Started
- 17 September 2026
- Main results due
- 31 December 2027
- Study sites
- 1
- Registry updated
- 28 September 2026
Can you take part?
- Ages 1 year to 17 years.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria: * Scheduled for open-heart surgery. * Age \<18 * Signed informed consent Exclusion Criteria: • Inability to provide informed consent
What this study is about
In the sponsor’s own words, from the registry.
The goal of this observational study is to investigate the ability of the SpectroCor Tissue Oxygenation Monitor and its accessory SpectroCor Sensor to observe and monitor changes in cardiac oxygen availability in pediatric patients during open-heart surgery.
Patients of less than 18 years old who, and whose guardian(s), when applicable according to national legislation, have signed the informed consent, can participate in the study.
The primary hypothesis is that the SpectroCor Tissue Oxygenation Monitor and its accessory SpectroCor Sensor can detect myocardial oxygen availability in pediatric open-heart surgery patients. It is expected that the detected tissue oxygenation timely correlates with procedures affecting myocardial perfusion and other clinical parameters during the operation.
The secondary hypothesis is that the SpectroCor Tissue Oxygenation Monitor and its accessory, the SpectroCor Sensor, are safe to use, and their usability is acceptable.
No comparison group is included in the study.
The devices are used by the study investigators during open-heart surgery to collect myocardial tissue spectrometer data from the pediatric population to validate and potentially further develop the monitor and its accessory, the sterile sensor. The follow-up period for each participant ends with discharge from the hospital. No data (such as questionnaires) are obtained directly from the study participants.
Study sites(1)
HUS New Childrens Hospital
Helsinki, Uusimaa, Finland
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07785141. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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