Performance Evaluation Study

NCT ID: NCT04618848

Last Updated: 2020-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-30

Study Completion Date

2020-12-31

Brief Summary

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This study aims to establish OLO's performance accuracy of CBC results for finger prick samples across the OLO reportable range, and particularly around relevant medical decision points

Detailed Description

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This study aims to establish OLO's performance accuracy of CBC results for finger prick samples across the OLO reportable range, and particularly around relevant medical decision points.

The evaluation will include two studies:

1. A matrix study will compare a capillary sample collected via finger prick with a venous sample collected into a blood tube, both scanned on OLO.
2. A method comparison study will compare Sight OLO to the site reference analyzer using a venous sample collected into a blood tube.

Conditions

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Hematology

Keywords

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Hematology

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Adult Oncology Patients

Adult oncology patients

Fingerstick blood draw

Intervention Type DIAGNOSTIC_TEST

Each participant shall be pricked twice in order to perform CBC test

Interventions

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Fingerstick blood draw

Each participant shall be pricked twice in order to perform CBC test

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Blood samples will be collected from oncologic patients older than 18 years old arriving at the oncologic daily care center of Ichilov hospital, with predefined normal and abnormal blood counts

Exclusion Criteria

* Patient younger than 18 years old
* Visibly hemolyzed specimens (sample plasma should be checked for hemolysis by technician while selection of specimen from tube racks).
* Visibly clotted specimens (Reasonable to assume that samples processed with clinical reported results are not clotted).
* A sample that is not successfully scanned on OLO within 3 attempts (e.g. rejected due to irregular cell morphology, or microscopically visible hemolysis).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tel Aviv Medical Center

OTHER

Sponsor Role collaborator

Sight Diagnostics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yochay Eshel

Role: PRINCIPAL_INVESTIGATOR

Sponsor GmbH

Central Contacts

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Yochay Eshel

Role: CONTACT

Phone: +972-52-8505747

Email: [email protected]

Tahel Naveh

Role: CONTACT

Phone: +972-54-6412600

Email: [email protected]

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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PR0156

Identifier Type: -

Identifier Source: org_study_id