Spectroscopic Assessment of Intramyocardial Oxygen Saturation Feasibility During Open-heart Surgery

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Heart Valve Diseases
• Intervention / Treatment: Device: Spectrocor device

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 (Actual): 15

Contacts and Locations

• Study Contact: Name: Peter Raivio, MD, PhD; Phone Number: +358 50 4272283; Email: peter.raivio@hus.fi

Study Locations

• Finland
  • Uusimaa
    • Helsinki, Uusimaa, Finland, 00029
      • Heart and Lung Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (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 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.

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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Tissue Spectrometry group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 1-14 During hospitalization

Collaborators and Investigators

• Sponsor: Spectrocor
• Collaborators: Hospital District of Helsinki and Uusimaa
• Investigators: Principal Investigator: Peter Raivio, Section Chief of Department, Head and Lung Center, Hospital District of Helsinki and Uusimaa

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2021
• Primary Completion (Actual): January 24, 2022
• Study Completion (Actual): January 24, 2022

Study Registration Dates

• First Submitted: September 7, 2021
• First Submitted That Met QC Criteria: July 26, 2022
• First Posted (Actual): July 29, 2022

Study Record Updates

• Last Update Posted (Estimated): October 9, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Monitoring, Intraoperative; Heart Surgery
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Heart Valve Diseases
• Other Study ID Numbers: Safe-op 1.0

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
• product manufactured in and exported from the U.S.: No