Tuberculosis, PulmonaryNCT05899400
A Study to Validate and Improve an Automated Image Analysis Algorithm to Detect Tuberculosis in Sputum Smear Slides
An observational study of Tuberculosis, Pulmonary, run by Diascopic, LLC at 1 site in Uganda.
Trial summary
A Study to Validate and Improve an Automated Image Analysis Algorithm to Detect Tuberculosis in Sputum Smear Slides Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tuberculosis, Pulmonary
- What is being tested?
- Diascopic iON Image Analysis System
- How many people
- 400 participants
- Where
- 1 siteUganda
- Study dates
- 15 Sep 2019to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 400 Male and Female Ugandan Africans
Who may be able to join
- Samples sourced from Makerere University's Joint Clinical Research Clinic (JCRC) and Laboratory
Who cannot join
- No samples from outside Makerere's Domain
Trial locations and contacts
1 site in 1 country.
About this study
A Study to Validate and Improve an Automated Image Analysis Algorithm to Detect Tuberculosis in Sputum Smear Slides
- Conditions
- Tuberculosis, Pulmonary
- Being tested
- Diascopic iON Image Analysis System
- Medical subject headings
- Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diascopic iON Image Analysis SystemDiagnostic test
A scanning digital optical train that images sputum slides for automated analysis by a tuberculosis detecting algorithm
| Study group | Role | What they receive |
|---|---|---|
| Study Group | 400 Male and Female Ugandan Africans Receives: Diagnostic Test: Diascopic iON Image Analysis System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determined sensitivity and specificity of the iON device by comparing MTB slide results to their associated bacterial culture results from the same specimen(s).
Sensitivity, specificity, and average analysis time were determined. An image database of >40,000 images was also created for internal use.
Measured: Study completed over the grant period 2019 - 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start15 Sep 2019
- Primary completion31 Oct 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis, PulmonaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diascopic, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Responsible party
- Sponsor
- Investigators
- Moses Joloba, MD, PhD, Study director, Makerere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05899400
- Sponsor's protocol ID
- Diascopic
- Other IDs
- 1R43EB028736-01
- Status last verified
- Jun 2023
- First submitted
- 31 May 2023
- Last updated
- 12 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Validate and Improve an Automated Image Analysis Algorithm to Detect Tuberculosis in Sputum Smear Slides
- ClinicalTrials.gov ID
- NCT05899400
- Acronym / sponsor ID
- Diascopic
- Conditions
- Tuberculosis, Pulmonary
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Diascopic, LLCIndustry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Study start
- 15 Sep 2019 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Study to Validate and Improve an Automated Image Analysis Algorithm to Detect Tuberculosis in Sputum Smear Slides
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Diagnostic Test: Diascopic iON Image Analysis System400 Male and Female Ugandan Africans |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 400 Male and Female Ugandan Africans
Key inclusion criteria (1 listed)
- Samples sourced from Makerere University's Joint Clinical Research Clinic (JCRC) and Laboratory
Key exclusion criteria (1 listed)
- No samples from outside Makerere's Domain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diascopic iON Image Analysis SystemA scanning digital optical train that images sputum slides for automated analysis by a tuberculosis detecting algorithm | Diagnostic test | Study Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moses Joloba, MD, PhD study director
Makerere University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, Pulmonary, run by Diascopic, LLC at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2023.