NCT04618848

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 2, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 6, 2020

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

November 6, 2020

Status Verified

November 1, 2020

Enrollment Period

1 month

First QC Date

November 2, 2020

Last Update Submit

November 2, 2020

Conditions

Hematology

Keywords

Hematology

Outcome Measures

Primary Outcomes (1)

  • CBC Comparison

    Comparison between CBC results obtained from the Sight OLO and the reference device in venous and capillary samples covering medical decision points relevant to onclology patient

    Immediately after sample collection is completed

Study Arms (1)

Adult Oncology Patients

Adult oncology patients

Diagnostic Test: Fingerstick blood draw

Interventions

Fingerstick blood drawDIAGNOSTIC_TEST

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

Adult Oncology Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Oncologic patient

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Yochay Eshel

    Sponsor GmbH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yochay Eshel

CONTACT

+972-52-8505747yochay@sightdx.com

Tahel Naveh

CONTACT

+972-54-6412600tahel@sightdx.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2020

First Posted

November 6, 2020

Study Start

November 1, 2020

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

November 6, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share