Colon CarcinimaNCT02628431
The Application of the ELFI-TECH Monitor for Perioperative Hemodynamic Measurements
An observational study of Colon Carcinima, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
The elfitor device is a small non invasive device that uses dynamic light scattering to measure skin bloodflow, blood velocity, coagulation and hemodynamic parameters. In this study, the investigators will investigate whether the elfitor device is able to detect changes in bloodpressure, cardiac output during general… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Carcinima
- What is being tested?
- Elfi tech monitor
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2015to 1 Jan 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
- No healthy volunteers
- Adult, Older adult
Study population: ASA 1-3 patients presenting for elective surgery under general or neuraxial anesthesia
Who may be able to join
- any elective surgery under general or neuraxial anesthesia
Who cannot join
- non elective procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Application of the ELFI-TECH Monitor for Measurement of Blood Pressure, Cardiac Output and Extend of Regional and Neuraxial Anesthesia: The Elfitor Study
The elfitor device is a small non invasive device that uses dynamic light scattering to measure skin bloodflow, blood velocity, coagulation and hemodynamic parameters. In this study, the investigators will investigate whether the elfitor device is able to detect changes in bloodpressure, cardiac output during general anesthesia. Furthermore, the investigators will investigate changes in cutanuous blood flow in different parts of the body during peripheral nerve or neuraxial block.Being able to monitor these entities, under- and overdosing of general and local anesthetics may be prevented, resulting in favorable hemodynamics and better intra and postoperative pain relieve.
- Conditions
- Colon Carcinima
- Being tested
- Elfi tech monitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elfi tech monitorDevice
Also called Elfitor
| Study group | Role | What they receive |
|---|---|---|
| General anesthesia | Patients that will recieve general anesthesia for elective surgery Receives: Device: Elfi tech monitor | |
| Regional or neuraxial anesthesia | Patients that will revieve regional or neuraxial anesthesia for elective surgery Receives: Device: Elfi tech monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
bloodpressure will be compared using conventional techniques and elfitor
Measured: up to 1 day
Neuraxial block
neuraxial block will be compared using conventional techniques and elfitor
Measured: up to 1 day
Secondary outcomes (1)
Cardiac output
during induction of anesthesia the effect of anesthetics or neuraxial blok on cardiac output will be recorded
Measured: up to 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study startOct 2015
- Primary completion1 Sep 2016
- Study completion1 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CarcinimaStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Albert Dahan, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02628431
- Sponsor's protocol ID
- P14.173
- Status last verified
- Sep 2019
- First submitted
- 6 Dec 2015
- Last updated
- 17 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of the ELFI-TECH Monitor for Measurement of Blood Pressure, Cardiac Output and Extend of Regional and Neuraxial Anesthesia: The Elfitor Study
- ClinicalTrials.gov ID
- NCT02628431
- Acronym / sponsor ID
- P14.173
- Conditions
- Colon Carcinima
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- 1 Sep 2016 (actual)
- Study completion
- 1 Jan 2017 (actual)
- First posted
- 11 Dec 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.
The elfitor device is a small non invasive device that uses dynamic light scattering to measure skin bloodflow, blood velocity, coagulation and hemodynamic parameters. In this study, the investigators will investigate whether the elfitor device is able to detect changes in bloodpressure, cardiac output during general anesthesia. Furthermore, the investigators will investigate changes in cutanuous blood flow in different parts of the body during peripheral nerve or neuraxial block.Being able to monitor these entities, under- and overdosing of general and local anesthetics may be prevented, resulting in favorable hemodynamics and better intra and postoperative pain relieve.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General anesthesia | – | Device: Elfi tech monitorPatients that will recieve general anesthesia for elective surgery |
| Regional or neuraxial anesthesia | – | Device: Elfi tech monitorPatients that will revieve regional or neuraxial anesthesia for elective surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ASA 1-3 patients presenting for elective surgery under general or neuraxial anesthesia
Key inclusion criteria (1 listed)
- any elective surgery under general or neuraxial anesthesia
Key exclusion criteria (1 listed)
- non elective procedures
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 |
|---|---|---|
| Elfi tech monitorAlso: Elfitor | Device | General anesthesia, Regional or neuraxial anesthesia |
Primary outcome
Blood pressure
Time frame: up to 1 day
bloodpressure will be compared using conventional techniques and elfitor
Neuraxial block
Time frame: up to 1 day
neuraxial block will be compared using conventional techniques and elfitor
1 secondary outcome
Cardiac output
Time frame: up to 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Colon Carcinima, run by Leiden University Medical Center at 1 site in Netherlands.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 17 Sep 2019. 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: up to 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Sep 2019.