Healthy VolunteerHEMOPTICNCT02843958
Validation of a Portable Medical Device for Diagnostic in Vitro
A study testing HEMOPTIC in people with Healthy Volunteer and Patients Under Vitamin K Antagonist (VKA), run by University Hospital, Grenoble at 1 site in France.
Trial summary
This clinical trial is about a new technology, named HEMOPTIC. It enables to mesure time of blood coagulation for monitoring of patients under Vitamin K antagonist (VKA). This device was created as an alternative to blood sample, that have to be done in a medical laboratory. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer, Patients Under Vitamin K Antagonist (VKA)
- What is being tested?
- HEMOPTIC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2013to Feb 2014
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Man or woman between 18 and 70 years
- Body Mass Index >18 and <29
- Absence of any acute pathology in the month preceding the study
- To be affiliated or beneficiary of social security
- Man or woman between 18 and 80 years
- Patient treated by oral anti vitamin K anticoagulants (coumadine, warfarine, fluidione)
- Absence of any acute pathology in the month preceding the study
- To be affiliated or beneficiary of social security
Who cannot join
- Pregnant, partutient or breastfeeding woman
- Patient with Raynaud's syndrome
- Person deprived of liberty by legal or administrative decision, person to a legal protection order
- Deferral periods for other clinical studies
- Annual threshold compensation attain for biomedical search participations
- Pregnant, partutient or breastfeeding woman
Show all 10Show fewer
- Patient with Raynaud's syndrome
- Person deprived of liberty by legal or administrative decision, person to a legal protection order
- Deferral periods for other clinical studies
- Annual threshold compensation attain for biomedical search participations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of a Portable Medical Device for Diagnostic in Vitro, Designed to Measure Blood Coagulation's Biological Parameters
This clinical trial is about a new technology, named HEMOPTIC. It enables to mesure time of blood coagulation for monitoring of patients under Vitamin K antagonist (VKA).
This device was created as an alternative to blood sample, that have to be done in a medical laboratory.
The main goal is to evaluate the accuracy of the International Normalized Ratio (INR) measurement of this new portable device for diagnostic in vitro, among healthy patients and patients under anti-vitamin K treatment.
- Being tested
- HEMOPTIC
- Keywords
- Medical device, Hemoptic, Vitamin K antagonist, Diagnostic in vitro
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEMOPTICDevice
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers and patients under Vitamin K antagonist | Other | Not described Receives: Device: HEMOPTIC |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Normalized Ratio measurement: comparison to the standard reference.
Measured: V2
Secondary outcomes (2)
International Normalized Ratio measurement: repeatability
Measured: V2
International Normalized Ratio measurement:reproductibility
Measured: V2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study startJun 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteerStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Luc Cracowski, Professor, Principal investigator, Grenoble Hospital University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02843958
- Sponsor's protocol ID
- 38RC14.008
- Acronym
- HEMOPTIC
- Status last verified
- Sep 2016
- First submitted
- 12 Jul 2016
- Last updated
- 30 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Heneghan C, Alonso-Coello P, Garcia-Alamino JM, Perera R, Meats E, Glasziou P. Self-monitoring of oral anticoagulation: a systematic review and meta-analysis. Lancet. 2006 Feb 4;367(9508):404-11. doi: 10.1016/S0140-6736(06)68139-7.
PubMed 16458764Faivre M, Peltie P, Planat-Chretien A, Cosnier ML, Cubizolles M, Nougier C, Negrier C, Pouteau P. Coagulation dynamics of a blood sample by multiple scattering analysis. J Biomed Opt. 2011 May;16(5):057001. doi: 10.1117/1.3573813.
PubMed 21639579Matchar DB, Jacobson A, Dolor R, Edson R, Uyeda L, Phibbs CS, Vertrees JE, Shih MC, Holodniy M, Lavori P; THINRS Executive Committee and Site Investigators. Effect of home testing of international normalized ratio on clinical events. N Engl J Med. 2010 Oct 21;363(17):1608-20. doi: 10.1056/NEJMoa1002617.
PubMed 20961244McBride GB (2005) A proposal for strength-of-agreement criteria for Lin's Concordance Correlation Coefficient. NIWA Client Report: HAM2005-062.
Riberolles, C. (2009). Résultats du PHRC autocontôle de l'anticoagulation. Conférence. XIXes Journées européennes de la Société française de cardiologie, Paris.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Portable Medical Device for Diagnostic in Vitro, Designed to Measure Blood Coagulation's Biological Parameters
- ClinicalTrials.gov ID
- NCT02843958
- Acronym / sponsor ID
- HEMOPTIC / 38RC14.008
- Keywords
- Medical device, Hemoptic, Vitamin K antagonist, Diagnostic in vitro
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 26 Jul 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.
This clinical trial is about a new technology, named HEMOPTIC. It enables to mesure time of blood coagulation for monitoring of patients under Vitamin K antagonist (VKA).
This device was created as an alternative to blood sample, that have to be done in a medical laboratory.
The main goal is to evaluate the accuracy of the International Normalized Ratio (INR) measurement of this new portable device for diagnostic in vitro, among healthy patients and patients under anti-vitamin K treatment.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers and patients under Vitamin K antagonist | Other | Device: HEMOPTIC |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Man or woman between 18 and 70 years
- Body Mass Index >18 and <29
- Absence of any acute pathology in the month preceding the study
- To be affiliated or beneficiary of social security
- Man or woman between 18 and 80 years
Key exclusion criteria (10 listed)
- Pregnant, partutient or breastfeeding woman
- Patient with Raynaud's syndrome
- Person deprived of liberty by legal or administrative decision, person to a legal protection order
- Deferral periods for other clinical studies
- Annual threshold compensation attain for biomedical search participations
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 |
|---|---|---|
| HEMOPTIC | Device | Healthy volunteers and patients under Vitamin K antagonist |
Primary outcome
International Normalized Ratio measurement: comparison to the standard reference.
Time frame: V2
2 secondary outcomes
International Normalized Ratio measurement: repeatability
Time frame: V2
International Normalized Ratio measurement:reproductibility
Time frame: V2
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 30 Sep 2016.
- Background: PubMed 16458764Heneghan C, Alonso-Coello P, Garcia-Alamino JM, Perera R, Meats E, Glasziou P. Self-monitoring of oral anticoagulation: a systematic review and meta-analysis. Lancet. 2006 Feb 4;367(9508):404-11. doi: 10.1016/S0140-6736(06)68139-7.
- Background: PubMed 21639579Faivre M, Peltie P, Planat-Chretien A, Cosnier ML, Cubizolles M, Nougier C, Negrier C, Pouteau P. Coagulation dynamics of a blood sample by multiple scattering analysis. J Biomed Opt. 2011 May;16(5):057001. doi: 10.1117/1.3573813.
- Background: PubMed 20961244Matchar DB, Jacobson A, Dolor R, Edson R, Uyeda L, Phibbs CS, Vertrees JE, Shih MC, Holodniy M, Lavori P; THINRS Executive Committee and Site Investigators. Effect of home testing of international normalized ratio on clinical events. N Engl J Med. 2010 Oct 21;363(17):1608-20. doi: 10.1056/NEJMoa1002617.
- BackgroundMcBride GB (2005) A proposal for strength-of-agreement criteria for Lin's Concordance Correlation Coefficient. NIWA Client Report: HAM2005-062.
- BackgroundRiberolles, C. (2009). Résultats du PHRC autocontôle de l'anticoagulation. Conférence. XIXes Journées européennes de la Société française de cardiologie, Paris.
Related trials for Healthy Volunteer
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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.
Jean-Luc Cracowski, Professor principal investigator
Grenoble Hospital University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HEMOPTIC in people with Healthy Volunteer and Patients Under Vitamin K Antagonist (VKA), 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 8 inclusion and 10 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 30 Sep 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 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?
International Normalized Ratio measurement: comparison to the standard reference. (time frame: V2). 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 NCT02843958, which also lists 5 linked publications.
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 30 Sep 2016.