NCT05479968

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

September 10, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2022

Completed
6 months until next milestone

First Posted

Study publicly available on registry

July 29, 2022

Completed
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

5 months

First QC Date

September 7, 2021

Last Update Submit

October 5, 2023

Conditions

Coronary Artery DiseaseHeart Valve Diseases

Keywords

Monitoring, IntraoperativeHeart Surgery

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Tissue Spectrometry group

The experimental group is subjected to testing the Specrocor Investigational Device.

Device: Spectrocor device

Interventions

Spectrocor deviceDEVICE

This feasibility study is intended to document the feasibility, safety, and usability of the Investigational device.

Tissue Spectrometry group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients scheduled for open-heart operation

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart and Lung Center

Helsinki, Uusimaa, 00029, Finland

Location

MeSH Terms

Conditions

Coronary Artery DiseaseHeart Valve Diseases

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Peter Raivio

    Section Chief of Department, Head and Lung Center, Hospital District of Helsinki and Uusimaa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2021

First Posted

July 29, 2022

Study Start

September 10, 2021

Primary Completion

January 24, 2022

Study Completion

January 24, 2022

Last Updated

October 10, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)