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Monitoring of Needle-placement With Multiple Frequency Bioimpedance Monitoring

Monitoring of Needle-placement With Multiple Frequency Bioimpedance Monitoring

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02589899
Enrollment
32
Registered
2015-10-28
Start date
2015-10-31
Completion date
2017-12-31
Last updated
2016-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Electric Impedance, Human, Hypodermic Needles, Nerve, Tissues

Brief summary

A novel algorithm for bioimpedance measurements to detect nerve tissue, and discriminate it from other tissue types has been developed in a porcine model, by analysing a complex impedance dataset based on multiple measurement frequencies. It must now be confirm that the previous results are applicable in humans. Measurements from 24 predefined needle positions will be obtained in 16 of the 32 volunteers that are included in the study (part A). A new algorithm to detect nerve tissue will be developed based on these measurement results. Further impedance algorithms will be developed for other tissue type. The efficacy of the algorithms (sensitivity and specificity) will be evaluated in the 16 following volunteers (part B).

Interventions

OTHERNeedle placement in different tissue types

Bioimpedance will be measured for needle positions in different tissue types

Sponsors

Oslo University Hospital
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Age ≥ 18 years * American society of anaesthesiologists score (ASA) 1 or 2 * Volunteers that have given informed written consent

Exclusion criteria

* Volunteers that cannot cooperate for the examination * Volunteers with neurologic disease, nerve- or vascular impairment * ASA \> 2

Design outcomes

Primary

MeasureTime frame
Success in the identification of nerve tissue by the use of an algorithm based on a multiple frequency impedance measurement (MFIM) algorithm. The outcome is binary (success vs failure).From day 1 up to 12 months

Countries

Norway

Contacts

Primary ContactAxel R Sauter, PhD
sauter@start.no23073700

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026