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Search / Trial NCT04893473

New Method for Real-time Detection of Tissue Ischemia

Launched by OSLO UNIVERSITY HOSPITAL · May 14, 2021

Trial Information

Current as of July 23, 2025

Withdrawn

Keywords

Ischemia Carbon Dioxide Biosensor Musculature Subcutaneous Surgery Orthopedic Limb

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.

Locations

Oslo, Please Select, Norway

Patients applied

0 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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