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New Method for Real-time Detection of Tissue Ischemia (ISCALERT)

NCT04879875 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-04-05

No results posted yet for this study

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. IscAlert is measuring CO2 in muscular and subcutaneous tissue. IscAlert is inserted into normal muscle and subcutaneous tissue in ischemic (operated limb with a tourniquet) and non-ischemic limb (non-operated limb).After the tourniquet is inflated, ischemia develops in the muscles and subcutaneous tissue. This will result in an increase in CO2, which will be detected by the sensors on the operated extremity, while the sensors on the non-operated will show normal values. After releasing the tourniquet cuff, the muscle will be reperfused and the CO2 level is expected to decrease into normal levels. 50 number of patients will be enrolled to undergo the procedures. The IscAlert will be removed from the patient before the patient is discharged from the operating room, but in 25 of the patients, IscAlert™ will be inserted for 72 hours in the operated extremity after the end of surgery. After this, the sensors are removed. 250 Devices is planned to be used in this clinical study.

Conditions

  • Ischemia
  • Blood Circulation Disorder
  • Carbon Dioxide
  • Biosensing Techniques

Interventions

DEVICE

IscAlert

3 IscAlert sensors in the limb undergoing surgery and two control sensors in the opposite limb are inserted and CO2 is measured continously. IscAlert sensors are removed after end of surgery.

DEVICE

IscAlert 72h

3 IscAlert sensors in the limb undergoing surgery and two control sensors in the opposite limb are inserted and CO2 is measured continously. IscAlert sensors are removed 72 hours after end of surgery

Sponsors & Collaborators

Principal Investigators

  • Magne Røkkum, Ph.d. · Oslo University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2022-07-24
Completion
2022-07-24

Countries

  • Norway

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04879875 on ClinicalTrials.gov