Coronary Artery DiseaseNCT05479968
Spectroscopic Assessment of Intramyocardial Oxygen Saturation Feasibility During Open-heart Surgery
An observational study of Coronary Artery Disease and Heart Valve Diseases, run by Spectrocor at 1 site in Finland.
Trial summary
This traditional feasibility study aims to capture preliminary safety and effectiveness information on a near-final Investigational Device design to adequately plan the forthcoming pivotal study. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Coronary Artery Disease, Heart Valve Diseases
- What is being tested?
- Spectrocor device
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteFinland
- Study dates
- 10 Sep 2021to 24 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for open-heart operation
Who may be able to join
- Any 18 to 90-year old patient scheduled for open-heart operation
- The ability to understand the objective of the study and the risks involved.
- Informed consent obtained, including the agreement to authorization to use the protected personal patient records according to privacy legislation.
Who cannot join
- Inability to obtain an informed consent form
- Patients included as vulnerable population according to Finnish Medical Research Act, including retarded, pregnant women, nursing mothers, prisoners, or forensic patients.
Trial locations and contacts
1 site in 1 country.
About this study
This traditional feasibility study aims to capture preliminary safety and effectiveness information on a near-final Investigational Device design to adequately plan the forthcoming pivotal study.
Read the detailed description
The study design is based on measuring the depth of ischemia during the operation, which is compared to the intraoperative and postoperative morbidity of the patient, especially to the dysfunction of the heart.
A qualified and experienced Monitor is assigned for the study to oversee and document the progress of the trial. The Monitor ensures the trial performance in accordance with the Protocol and Good Clinical Practice (GCP).
The trial team conforms to ISO 13485 quality standards and ISO 14155 GCP. Processes included in the monitoring activities are documented in the quality management system. Below are described the summaries of all these activities.
Source data will be collected and transferred into the electronic CRFs by site staff, and the collected data quality and the conformity to the Good Clinical Practice will be assessed by monitoring. Based on a risk assessment performed, a Data Monitoring Committee shall not be established.
Clinical Research Associate (CRA) is responsible for checking the accuracy and completeness of Case Report Form (CRF) entries, source documents, and other investigation-related records against each other. Other responsibilities of CRA, including detailed Source Data Verification (SDV), are documented by the clinical project manager (CPM) or head of clinical research (HCR)(both are sponsor's representatives). SDVs will be performed and documented during monitoring visits.
Monitoring planning, reporting, and visits are pre-defined and documented with pre-made templates per the sponsor's quality management system. Monitoring visits will be performed to cover data from all study participants, and according to QMS and the Standard Operation Procedures.
The monitoring shall ensure that all source documentation is precise and document control is exercised in all relevant documentation. The monitoring ensures, that the Adverse events are always reported and appropriate authorities or stakeholders are informed.
- Conditions
- Coronary Artery Disease, Heart Valve Diseases
- Being tested
- Spectrocor device
- Keywords
- Monitoring, Intraoperative, Heart Surgery
- Medical subject headings
- Coronary Artery Disease, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spectrocor deviceDevice
This feasibility study is intended to document the feasibility, safety, and usability of the Investigational device.
| Study group | Role | What they receive |
|---|---|---|
| Tissue Spectrometry group | The experimental group is subjected to testing the Specrocor Investigational Device. Receives: Device: Spectrocor device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with device-related adverse events as assessed by CTCAE v4.0
This traditional feasibility study aims to capture preliminary safety and effectiveness information on a near-final device design
Measured: Day 1-14 During hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start10 Sep 2021
- Primary completion24 Jan 2022
- Study completion24 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spectrocor
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital District of Helsinki and Uusimaa
- Responsible party
- Sponsor
- Investigators
- Peter Raivio, Principal investigator, Section Chief of Department, Head and Lung Center, Hospital District of Helsinki and Uusimaa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05479968
- Sponsor's protocol ID
- Safe-op 1.0
- Status last verified
- Oct 2023
- First submitted
- 7 Sep 2021
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Raivio P, Petaja L, Granvik A, Ojala T, Wilkman E, Jormalainen M, Haapanen H, Lax M, Soljanlahti S, Tuohinen S, Stark C, Haavisto E, Kankuri E, Kotilahti K, Meinberg M, Juvonen T, Patila T. Intraoperative monitoring of myocardial oxygenation during open-heart surgery: feasibility and initial performance. J Clin Monit Comput. 2026 Sep 24. doi: 10.1007/s10877-026-01504-1. Online ahead of print.
PubMed 42782490
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spectroscopic Assessment of Intramyocardial Oxygen Saturation Feasibility During Open-heart Surgery
- ClinicalTrials.gov ID
- NCT05479968
- Acronym / sponsor ID
- Safe-op 1.0
- Conditions
- Coronary Artery Disease, Heart Valve Diseases
- Keywords
- Monitoring, Intraoperative, Heart Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- SpectrocorIndustry (pharma, biotech, devices)
- Collaborators
- Hospital District of Helsinki and Uusimaa
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 24 Jan 2022 (actual)
- Study completion
- 24 Jan 2022 (actual)
- First posted
- 29 Jul 2022 (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.
This traditional feasibility study aims to capture preliminary safety and effectiveness information on a near-final Investigational Device design to adequately plan the forthcoming pivotal study.
Detailed description
The study design is based on measuring the depth of ischemia during the operation, which is compared to the intraoperative and postoperative morbidity of the patient, especially to the dysfunction of the heart.
A qualified and experienced Monitor is assigned for the study to oversee and document the progress of the trial. The Monitor ensures the trial performance in accordance with the Protocol and Good Clinical Practice (GCP).
The trial team conforms to ISO 13485 quality standards and ISO 14155 GCP. Processes included in the monitoring activities are documented in the quality management system. Below are described the summaries of all these activities.
Source data will be collected and transferred into the electronic CRFs by site staff, and the collected data quality and the conformity to the Good Clinical Practice will be assessed by monitoring. Based on a risk assessment performed, a Data Monitoring Committee shall not be established.
Clinical Research Associate (CRA) is responsible for checking the accuracy and completeness of Case Report Form (CRF) entries, source documents, and other investigation-related records against each other. Other responsibilities of CRA, including detailed Source Data Verification (SDV), are documented by the clinical project manager (CPM) or head of clinical research (HCR)(both are sponsor's representatives). SDVs will be performed and documented during monitoring visits.
Monitoring planning, reporting, and visits are pre-defined and documented with pre-made templates per the sponsor's quality management system. Monitoring visits will be performed to cover data from all study participants, and according to QMS and the Standard Operation Procedures.
The monitoring shall ensure that all source documentation is precise and document control is exercised in all relevant documentation. The monitoring ensures, that the Adverse events are always reported and appropriate authorities or stakeholders are informed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tissue Spectrometry group | – | Device: Spectrocor deviceThe experimental group is subjected to testing the Specrocor Investigational Device. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for open-heart operation
Key inclusion criteria (3 listed)
- Any 18 to 90-year old patient scheduled for open-heart operation
- The ability to understand the objective of the study and the risks involved.
- Informed consent obtained, including the agreement to authorization to use the protected personal patient records according to privacy legislation.
Key exclusion criteria (2 listed)
- Inability to obtain an informed consent form
- Patients included as vulnerable population according to Finnish Medical Research Act, including retarded, pregnant women, nursing mothers, prisoners, or forensic patients.
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 |
|---|---|---|
| Spectrocor deviceThis feasibility study is intended to document the feasibility, safety, and usability of the Investigational device. | Device | Tissue Spectrometry group |
Primary outcome
Number of participants with device-related adverse events as assessed by CTCAE v4.0
Time frame: Day 1-14 During hospitalization
This traditional feasibility study aims to capture preliminary safety and effectiveness information on a near-final device design
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Derived from this study: PubMed 42782490Raivio P, Petaja L, Granvik A, Ojala T, Wilkman E, Jormalainen M, Haapanen H, Lax M, Soljanlahti S, Tuohinen S, Stark C, Haavisto E, Kankuri E, Kotilahti K, Meinberg M, Juvonen T, Patila T. Intraoperative monitoring of myocardial oxygenation during open-heart surgery: feasibility and initial performance. J Clin Monit Comput. 2026 Sep 24. doi: 10.1007/s10877-026-01504-1. Online ahead of print.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Peter Raivio principal investigator
Section Chief of Department, Head and Lung Center, Hospital District of Helsinki and Uusimaa
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 Coronary Artery Disease and Heart Valve Diseases, run by Spectrocor at 1 site in Finland.
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: finished, as of the sponsor's last update on 10 Oct 2023. 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 Finland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with device-related adverse events as assessed by CTCAE v4.0 (time frame: Day 1-14 During hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05479968, which also lists 1 linked publication.
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 10 Oct 2023.