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

NCT05479968 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2023-10-10

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Spectrocor device

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

Sponsors & Collaborators

  • Hospital District of Helsinki and Uusimaa

    collaborator OTHER
  • Spectrocor

    lead INDUSTRY

Principal Investigators

  • Peter Raivio · Section Chief of Department, Head and Lung Center, Hospital District of Helsinki and Uusimaa

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-10
Primary Completion
2022-01-24
Completion
2022-01-24

Countries

  • Finland

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05479968 on ClinicalTrials.gov