Status:
COMPLETED
New Method for Real-time Detection of Tissue Ischemia (ISCALERT)
Lead Sponsor:
Oslo University Hospital
Collaborating Sponsors:
European Commission
Conditions:
Ischemia
Blood Circulation Disorder
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a prospective, single arm, open, single centre clinical investigation designed to examine the feasibility and safety of the IscAlert™ device in patients scheduled for limb (arm/leg) surgery wi...
Detailed Description
This is a prospective, single arm, open, single centre clinical investigation designed to examine the feasibility and safety of the IscAlert™ device in patients scheduled for limb (arm/leg) surgery wi...
Eligibility Criteria
Inclusion
- Patients must be scheduled for orthopedic limb surgery with planned use of tourniquet.
- Subject must be ≥ 18 years
- Able to give written signed informed consent
- Tourniquet planned to be used \> 30 minutes
Exclusion
- Sign of inflammation/infection, hematoma, and traumatized tissue at insertion site
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 24 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04879875
Start Date
September 1 2021
End Date
July 24 2022
Last Update
April 5 2024
Active Locations (1)
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1
Oslo University Hospital
Oslo, Norway, 0424