Electric ImpedanceNCT02589899
Monitoring of Needle-placement With Multiple Frequency Bioimpedance Monitoring
An observational study of Electric Impedance and Human, run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Electric Impedance, Human, Hypodermic Needles
- What is being tested?
- Needle placement in different tissue types
- How many people
- 32 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2015to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers
Who may be able to join
- Age ≥ 18 years
- American society of anaesthesiologists score (ASA) 1 or 2
- Volunteers that have given informed written consent
Who cannot join
- Volunteers that cannot cooperate for the examination
- Volunteers with neurologic disease, nerve- or vascular impairment
- ASA > 2
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Oslo University Hospital
Oslo, Oslo, 0424
Leiv Arne Rosseland, PhD, Professor, 23070000 ext. +41, l.a.rosseland@medisin.uio.no
About this study
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).
- Conditions
- Electric Impedance, Human, Hypodermic Needles, Tissues, Nerve
- Being tested
- Needle placement in different tissue types
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Needle placement in different tissue typesOther
Bioimpedance will be measured for needle positions in different tissue types
| Study group | Role | What they receive |
|---|---|---|
| Needle placement in different tissue types | Needle placement and impedance measurements in different tissue types Receives: Other: Needle placement in different tissue types |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From day 1 up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Electric ImpedanceStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Axel Rudolf Sauter, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02589899
- Sponsor's protocol ID
- impedance monitoring 1/2015
- Status last verified
- Jun 2016
- First submitted
- 22 Oct 2015
- Last updated
- 8 Jun 2016
- Results posted
- No
Publications
Kalvoy H, Sauter AR. Detection of intraneural needle-placement with multiple frequency bioimpedance monitoring: a novel method. J Clin Monit Comput. 2016 Apr;30(2):185-92. doi: 10.1007/s10877-015-9698-3. Epub 2015 Apr 23.
PubMed 25902898
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of Needle-placement With Multiple Frequency Bioimpedance Monitoring
- ClinicalTrials.gov ID
- NCT02589899
- Acronym / sponsor ID
- impedance monitoring 1/2015
- Conditions
- Electric Impedance, Human, Hypodermic Needles, Tissues, Nerve
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 28 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Needle placement in different tissue types | – | Other: Needle placement in different tissue typesNeedle placement and impedance measurements in different tissue types |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- American society of anaesthesiologists score (ASA) 1 or 2
- Volunteers that have given informed written consent
Key exclusion criteria (3 listed)
- Volunteers that cannot cooperate for the examination
- Volunteers with neurologic disease, nerve- or vascular impairment
- ASA > 2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Needle placement in different tissue typesBioimpedance will be measured for needle positions in different tissue types | Other | Needle placement in different tissue types |
Primary outcome
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).
Time frame: From day 1 up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2016.
- Background: PubMed 25902898Kalvoy H, Sauter AR. Detection of intraneural needle-placement with multiple frequency bioimpedance monitoring: a novel method. J Clin Monit Comput. 2016 Apr;30(2):185-92. doi: 10.1007/s10877-015-9698-3. Epub 2015 Apr 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Electric Impedance and Human, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Axel R Sauter, PhD (23073700 ext. +47, sauter@start.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: From day 1 up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02589899, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2016.