An observational study in Coronary Artery Disease and Heart Valve Diseases, sponsored by Spectrocor. Completed at 1 site in Finland. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-10-10.
Sponsored by Spectrocor · Observational
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.
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.
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's enrollment of 15 is below the median of 320 across 1,687 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Spectrocor is the lead sponsor of 5 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients scheduled for open-heart operation
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The experimental group is subjected to testing the Specrocor Investigational Device.
Device: Spectrocor device
This feasibility study is intended to document the feasibility, safety, and usability of the Investigational device.
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
Time frame: Day 1-14 During hospitalization
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2021 to primary completion in Jan 2022, 4 months.
Of 125 industry-sponsored observational studies under Coronary Artery Disease, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 40. This study's 4 months is below that.
Counting every sponsor, half of 759 studies reached it within 40 months; a quarter within 21 and three quarters within 87.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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