Validation of a Portable Medical Device for Diagnostic in... | NCT02843958

Studies
Validation of a Portable Medical Device for Diagnostic in Vitro

NCT02843958

Sponsor

University Hospital, Grenoble

Status

Completed

Last Update Posted

Sep 30, 2016Estimated

Enrollment

40Actual

Phase

Not Applicable

Conditions

Healthy Volunteer
Patients Under Vitamin K Antagonist (VKA)

Interventions

HEMOPTIC

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2013

Primary Completion Date

Feb 2014Actual

Completion Date

Feb 2014Actual

First Submitted Date

Jul 12, 2016

First Submission Date that Met QC Criteria

Jul 22, 2016

First Posted Date

Jul 26, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 29, 2016

Last Update Posted Date

Sep 30, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Label	Type	Description	Intervention Names
Healthy volunteers and patients under Vitamin K antagonist	Other		Device: HEMOPTIC

Name	Type	Description	Arm Group Labels	Other Names
HEMOPTIC	Device		Healthy volunteers and patients under Vitamin K antagonist

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
International Normalized Ratio measurement: comparison to the standard reference.		V2

Secondary Outcomes

Measure	Description	Time Frame
International Normalized Ratio measurement: repeatability		V2
International Normalized Ratio measurement:reproductibility		V2

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Jean-Luc Cracowski, Professor	Grenoble Hospital University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
UniversityHospitalGrenoble		La Tronche		38700	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16458764	Background	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.
21639579	Background	Faivre 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.