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

NCT ID: NCT05899400

Last Updated: 2023-06-12

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-15

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tuberculosis, Pulmonary

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Study Group

400 Male and Female Ugandan Africans

Diascopic iON Image Analysis System

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Diascopic iON Image Analysis System

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* No samples from outside Makerere's Domain
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

NIH

Sponsor Role collaborator

Diascopic, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Moses Joloba, MD, PhD

Role: STUDY_DIRECTOR

Makerere University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Makerere University

Kampala, , Uganda

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Uganda

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1R43EB028736-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Diascopic

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.