New Method for Real-time Detection of Tissue Ischemia
Launched by OSLO UNIVERSITY HOSPITAL · May 14, 2021
Trial Information
Current as of July 25, 2025
Withdrawn
Keywords
ClinConnect 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 with tourniquet.
50 number of patients will be enrolled to undergo the procedures detailed in this clinical investigational plan using 250 devices.
IscAlert is 0.8 mm in diameter and in vitro testing, shows stable and accurate measurements of tissue carbon dioxide . More than 100 animal experiments have been done with the sensor. The experiments have shown that the sensor detects ischemia (Incr...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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 Criteria:
- • Sign of inflammation/infection, hematoma, and traumatized tissue at insertion site
- • Chronic use of anticoagulants
About Oslo University Hospital
Oslo University Hospital is a leading academic medical center in Norway, renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical studies, the hospital integrates cutting-edge scientific inquiry with patient care, fostering an environment that promotes the development of new therapies and treatment strategies. With a multidisciplinary approach, Oslo University Hospital collaborates with various stakeholders, including researchers, healthcare professionals, and industry partners, to enhance clinical outcomes and contribute to the global medical community. Its dedication to ethical standards and patient safety ensures that all trials are conducted with the highest level of integrity and respect for participant welfare.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Oslo, Please Select, Norway
Patients applied
Trial Officials
Magne Røkkum, Md, Ph.d
Principal Investigator
Oslo University Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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