HealthyHEMOPTICS2NCT02779400
Assessment of a Diagnostic Medical Device for the INR (International Normalized Ratio) Measurement
A study testing Self testing INR device in people with Healthy and Heart Valves, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The purpose of this study is to assess the measurement conformity of an in vitro diagnostic device measuring the INR (International harmonized Ratio). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, Heart Valves, Arrhythmias, Cardiac
- What is being tested?
- Self testing INR device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteFrance
- Study dates
- 23 May 2016to 1 Jun 2018
- Phase
- Interventional
- 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
Who may be able to join
- Patients treated with vitamin K agonist or healthy volunteers
- For healthy volunteers : Body Mass index between 18 ans 29 kg/m²
- No acute disease in the previous month
Who cannot join
- Pregnant woman
Trial locations and contacts
1 site in 1 country.
France1 site
Clinical research center of Grenoble university hospital
Grenoble, Auvergne-Rhône-Alpes, 38043
About this study
Official title: Conformity Measurement Assessment of a Diagnostic Medical Device Used for the Measurement of the INR (International Normalized Ratio)
The purpose of this study is to assess the measurement conformity of an in vitro diagnostic device measuring the INR (International harmonized Ratio).
Read the detailed description
The investigators will assess the performance of an in vitro diagnostic device for assessing the INR.
The evaluation will consist of make several INR measurements using the device and compare these measures to the reference value.
The INR will be measured using the study device on capillary blood drops taken from the fingertip. In the same way a venous blood sampling will be carried out to measure a reference INR.
A total of 20 healthy subjects and 180 patients treated with vitamin K agonist will be enrolled in the study.
- Conditions
- Healthy, Heart Valves, Arrhythmias, Cardiac, Thromboembolism
- Being tested
- Self testing INR device
- Keywords
- INR, coagulation, vitamin K antagonist
- Medical subject headings
- Arrhythmias, Cardiac, Thromboembolism, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self testing INR deviceDevice
Also called In vitro diagnostic device measuring INR
the procedure involves a series of repeated measurements of INR with the studied device
| Study group | Role | What they receive |
|---|---|---|
| Evaluation of the device perfomance | Experimental | Not described Receives: Device: Self testing INR device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of measurement of the INR with the study device
The INR value of each measure with the study device will be compared to the reference INR measured by a central laboratory on a concomitant venous blood sample.
Measured: Just after the blood taken at day 1
Secondary outcomes (2)
Repeatability of measurement of the INR with the study device
Comparison of 8 INR measurements performed with the device in a range of 15 minutes.
Measured: Just after the blood taken at day 1
Reproductibility of measurement of the INR with the study device
Comparison of 8 INR measurements performed with the device in a range of 15 minutes. The modified parameters between measurements will be the lot of consumables and the study device
Measured: Just after the blood taken at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study start23 May 2016
- Primary completion14 Apr 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02779400
- Sponsor's protocol ID
- DCIC/14/54
- Acronym
- HEMOPTICS2
- Status last verified
- Oct 2018
- First submitted
- 27 Aug 2015
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conformity Measurement Assessment of a Diagnostic Medical Device Used for the Measurement of the INR (International Normalized Ratio)
- ClinicalTrials.gov ID
- NCT02779400
- Acronym / sponsor ID
- HEMOPTICS2 / DCIC/14/54
- Conditions
- Healthy, Heart Valves, Arrhythmias, Cardiac, Thromboembolism
- Keywords
- INR, coagulation, vitamin K antagonist
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 23 May 2016 (actual)
- Primary completion
- 14 Apr 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 20 May 2016 (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 purpose of this study is to assess the measurement conformity of an in vitro diagnostic device measuring the INR (International harmonized Ratio).
Detailed description
The investigators will assess the performance of an in vitro diagnostic device for assessing the INR.
The evaluation will consist of make several INR measurements using the device and compare these measures to the reference value.
The INR will be measured using the study device on capillary blood drops taken from the fingertip. In the same way a venous blood sampling will be carried out to measure a reference INR.
A total of 20 healthy subjects and 180 patients treated with vitamin K agonist will be enrolled in the study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluation of the device perfomance | Experimental | Device: Self testing INR device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients treated with vitamin K agonist or healthy volunteers
- For healthy volunteers : Body Mass index between 18 ans 29 kg/m²
- No acute disease in the previous month
Key exclusion criteria (1 listed)
- Pregnant woman
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 |
|---|---|---|
| Self testing INR deviceAlso: In vitro diagnostic device measuring INRthe procedure involves a series of repeated measurements of INR with the studied device | Device | Evaluation of the device perfomance |
Primary outcome
Accuracy of measurement of the INR with the study device
Time frame: Just after the blood taken at day 1
The INR value of each measure with the study device will be compared to the reference INR measured by a central laboratory on a concomitant venous blood sample.
2 secondary outcomes
Repeatability of measurement of the INR with the study device
Time frame: Just after the blood taken at day 1
Reproductibility of measurement of the INR with the study device
Time frame: Just after the blood taken at day 1
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 15 Oct 2018.
- Individual participant dataSharing planned: No
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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.
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?
A study testing Self testing INR device in people with Healthy and Heart Valves, run by University Hospital, Grenoble at 1 site in France.
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 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 15 Oct 2018. 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 France. 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?
Accuracy of measurement of the INR with the study device (time frame: Just after the blood taken at day 1). 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 15 Oct 2018.