- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06084091
Spectroscopic Assessment of Intramyocardial Oxygen Saturation During Open-Heart Surgery (ECS)
October 24, 2023 updated by: Spectrocor
The goal of this observational study is to test in the safety and performance of intraoperative myocardial spectroscopic measurement in open-heart surgery patients
The main questions it aims to answer are:
- The Devices can record myocardial spectrometric data for analysis, and
- How these measures correlate with the occurring events, procedures, and clinical parameters during the operation.
- Number of participants with device-related adverse events as assessed by CTCAE v4.0
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Estimated)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Tatu Juvonen, Professor
- Phone Number: +358 50 4080562
- Email: tatu.juvonen@hus.fi
Study Contact Backup
- Name: Peter Raivio, PhD
- Phone Number: +358 50 4272283
- Email: peter.raivio@hus.fi
Study Locations
-
-
Uusimaa
-
Helsinki, Uusimaa, Finland, 00029
- Recruiting
- Heart and Lung Center
-
Contact:
- Peter Raivio, MD, PhD
- Phone Number: +358 50 4272283
- Email: peter.raivio@hus.fi
-
Contact:
- Tatu Juvonen, Professor
- Phone Number: +358 50 4080562
- Email: tatu.juvonen@hus.fi
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients scheduled for open-heart operation
Description
Inclusion Criteria:
- Any 18 to 90-year-old patient scheduled for an open-heart operation
- The ability to understand the study's objective and the risks involved.
- Informed consent obtained, including the agreement to authorization to use the protected personal patient records according to privacy legislation.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Myocardial spectrometric recording
Time Frame: During operation
|
Can the device record myocardial spectrometric data during open-heart surgery
|
During operation
|
Measurement correlation
Time Frame: During operation
|
How the measurements correlate with the occurring events, procedures, and clinical parameters during the operation.
|
During operation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse event assessment
Time Frame: From admission to discharge, up to 2 weeks
|
Assessment of the adverse events of the device.
|
From admission to discharge, up to 2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Peter Raivio, PhD, Chief of Department, Head and Lung Center, Hospital District of Helsinki and Uusimaa
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 6, 2023
Primary Completion (Estimated)
November 30, 2025
Study Completion (Estimated)
November 30, 2025
Study Registration Dates
First Submitted
October 5, 2023
First Submitted That Met QC Criteria
October 11, 2023
First Posted (Actual)
October 16, 2023
Study Record Updates
Last Update Posted (Actual)
October 25, 2023
Last Update Submitted That Met QC Criteria
October 24, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Safe-op 1.0 ECS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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