Spectroscopic Assessment of Intramyocardial Oxygen Saturation Feasibility During Open-heart Surgery
NCT05479968 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 15
Last updated 2023-10-10
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
- Coronary Artery Disease
- Heart Valve Diseases
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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