Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Validation of a Portable Medical Device for Diagnostic in Vitro (HEMOPTIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02843958
Recruitment Status : Completed
First Posted : July 26, 2016
Last Update Posted : September 30, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Healthy Volunteer Patients Under Vitamin K Antagonist (VKA) Device: HEMOPTIC Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Validation of a Portable Medical Device for Diagnostic in Vitro, Designed to Measure Blood Coagulation's Biological Parameters
Study Start Date : June 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin K

Arm Intervention/treatment
Healthy volunteers and patients under Vitamin K antagonist Device: HEMOPTIC



Primary Outcome Measures :
  1. International Normalized Ratio measurement: comparison to the standard reference. [ Time Frame: V2 ]

Secondary Outcome Measures :
  1. International Normalized Ratio measurement: repeatability [ Time Frame: V2 ]
  2. International Normalized Ratio measurement:reproductibility [ Time Frame: V2 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria of healthy volunteers:

  • 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

Exclusion Criteria of healthy volunteers:

  • 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

Inclusion Criteria of patients:

  • 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

Exclusion Criteria of healthy patients:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02843958


Locations
Layout table for location information
France
UniversityHospitalGrenoble
La Tronche, France, 38700
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Layout table for investigator information
Principal Investigator: Jean-Luc Cracowski, Professor Grenoble Hospital University
Publications:
Layout table for additonal information
Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02843958    
Other Study ID Numbers: 38RC14.008
First Posted: July 26, 2016    Key Record Dates
Last Update Posted: September 30, 2016
Last Verified: September 2016
Keywords provided by University Hospital, Grenoble:
Medical device
Hemoptic
Vitamin K antagonist
Diagnostic in vitro