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Completed

NCT Number: NCT05899400

A Study to Validate and Improve an Automated Image Analysis Algorithm to Detect Tuberculosis in Sputum Smear Slides

A Study to Validate and Improve an Automated Image Analysis Algorithm to Detect Tuberculosis in Sputum Smear Slides

Completed

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Key information

Conditions

Tuberculosis, Pulmonary Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Lung Diseases Mycobacterium Infections Respiratory Tract Diseases Respiratory Tract Infections Tuberculosis

Sex eligibility

All sexes

Study type

Observational

Primary location

Makerere University

Kampala, Uganda

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Samples sourced from Makerere University's Joint Clinical Research Clinic (JCRC) and Laboratory

Exclusion criteria

  • No samples from outside Makerere's Domain

Treatment and study plan

Diascopic iON Image Analysis System

Diagnostic Test

A scanning digital optical train that images sputum slides for automated analysis by a tuberculosis detecting algorithm

Primary outcomes

  1. Determined sensitivity and specificity of the iON device by comparing MTB slide results to their associated bacterial culture results from the same specimen(s).

    Time frame: Study completed over the grant period 2019 - 2022

    Sensitivity, specificity, and average analysis time were determined. An image database of >40,000 images was also created for internal use.

Sponsors and collaborators

Lead sponsor

Diascopic, LLC

Industry

Collaborators

  • National Institute for Biomedical Imaging and Bioengineering (NIBIB)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jun 12, 2023
Registry last updated
Jun 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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