Status:
RECRUITING
Early Discovery of Ischemia After Replantation Surgery of the Extremities
Lead Sponsor:
Oslo University Hospital
Collaborating Sponsors:
Sensocure AS
Conditions:
Ischemia
Blood Circulation Disorder
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
Investigators will test if changes in CO2 is detected postoperatively in ischemic tissue in a replanted extremity of a traumatically amputated upper or lower extremity. IscAlert is measuring continuou...
Detailed Description
This is an open, prospective, interventional, single-center clinical investigation designed to examine the feasibility and safety of the IscAlert™ device in patients scheduled for extremity replant su...
Eligibility Criteria
Inclusion
- Patients must be in need of extremity replantation surgery
- Subject must be ≥ 18 years
- Able to give written signed informed consent
Exclusion
- None
Key Trial Info
Start Date :
November 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05297266
Start Date
November 15 2022
End Date
November 30 2025
Last Update
March 25 2025
Active Locations (1)
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1
Oslo University Hospital
Oslo, Norway, 0424