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

Sponsor

Spectrocor (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05479968

Collaborator

Hospital District of Helsinki and Uusimaa (Other)

Enrollment

Location

Arm

15.7

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Heart Valve Diseases	Device: Spectrocor device	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

Sep 10, 2021

Anticipated Primary Completion Date :

Aug 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.

Arm

Intervention/Treatment

Experimental: 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.

Outcome Measures

Primary Outcome Measures

Number of participants with device-related adverse events as assessed by CTCAE v4.0 [Day 1-14 During hospitalization]
This traditional feasibility study aims to capture preliminary safety and effectiveness information on a near-final device design

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Heart and Lung Center	Helsinki	Uusimaa	Finland	00029

Sponsors and Collaborators

Spectrocor
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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Spectrocor

ClinicalTrials.gov Identifier:

NCT05479968

Other Study ID Numbers:

Safe-op 1.0

First Posted:

Jul 29, 2022

Last Update Posted:

Jul 29, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Spectrocor

Monitoring, Intraoperative

Heart Surgery

Additional relevant MeSH terms:

Coronary Artery Disease

Heart Valve Diseases

Study Results

No Results Posted as of Jul 29, 2022