Anemia (Diagnosis)AnemiAINCT07678762
Multicenter, Prospective Study Evaluating the Accuracy of an AI-based Smartphone Application for Non-invasive Anemia Detection
A study testing AnemIA App in people with Anemia (Diagnosis) and Anemia, run by Fabio Biscegli Jatene at 1 site in Brazil.
Trial summary
Title: Multicenter, prospective study evaluating the accuracy of an AI-based smartphone application for non-invasive anemia - AnemiAI trial Short Introduction: Anemia is a common clinical condition, often underdiagnosed, with significant impact on surgical, vulnerable, and underserved populations with limited access… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anemia (Diagnosis), Anemia
- What is being tested?
- AnemIA App
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Mar 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age >18 years old
- Any gender or ethnicity
- Hospitalized or outpatient
Who cannot join
- Juandice or other yelid discoloration
- Severe skin hyperpigmentation
- Dressings, injuries or deformities at the analysis site
- Infections, trauma, or scarring on or near the eye
- Hemoglobinopathies
- Hemolyzed or invalidez laboratory samples
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- Hemodynamically unstable or unconscious patients
- Participants with communication or comprehension difficulties
- Patients who received blood transfusion within the last 24 hours
- Use of a tropical eye medication
- Pregnant Women
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto do Coração do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, São Paulo, 05403900
About this study
Official title: Multicenter, Prospective Study Evaluating the Accuracy of an AI-based Smartphone Application for Non-invasive Anemia Detection - AnemiAI Trial
Title: Multicenter, prospective study evaluating the accuracy of an AI-based smartphone application for non-invasive anemia - AnemiAI trial Short Introduction: Anemia is a common clinical condition, often underdiagnosed, with significant impact on surgical, vulnerable, and underserved populations with limited access to laboratory testing. The NiADA technology uses artificial intelligence to estimate hemoglobin levels from images of the lower palpebral conjunctiva, offering a non-invasive, rapid, and accessible alternative to conventional diagnostics. Purpose: To evaluate the diagnostic accuracy of the NiADA application for non-invasive anemia detection, compared to the standard laboratory method (venous blood draw).
Study Design: Following informed consent, participants will undergo clinical data collection and non-invasive hemoglobin estimation using the NiADA application, operated by a trained healthcare professional. The lower palpebral conjunctiva will be imaged using a compatible smartphone camera, and the app result will be recorded immediately. Within four hours of the app assessment, a venous blood sample will be collected for laboratory hemoglobin analysis, following institutional protocols. Both results - from the app and laboratory - will be recorded on the REDCap platform. Additionally, patients will complete a brief acceptability questionnaire. Execution time, technical errors, and task completion rates will also be monitored. All centers will follow a standardized data collection protocol to ensure methodological consistency and data integrity. Study Population Sample Size (n) Adult patients (≥18 years), hospitalized or in outpatient care, with a clinical request for hemoglobin testing.
Inclusion Criteria Age ≥18 years Any gender or ethnicity Clinical indication for venous hemoglobin testing
- Conditions
- Anemia (Diagnosis), Anemia
- Being tested
- AnemIA App
- Keywords
- Anemia, Diagnosis, AI, Artificial Inteligence
- Medical subject headings
- Anemia, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnemIA AppDevice
Detection of Anemia using an AI App
| Study group | Role | What they receive |
|---|---|---|
| Hemoglobin detection | Active comparator | Patients will be tested both with the app and the gold standard test for anemia. Receives: Device: AnemIA App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity of the NiADA Smartphone Application for Detection of Anemia
Sensitivity and specificity of the NiADA smartphone application for detecting anemia compared with laboratory hemoglobin measurement (g/dL), used as the reference standard.
Measured: From enrollment to completion of anemia assessment (up to 1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start2 Mar 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia (Diagnosis)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fabio Biscegli Jatene
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fabio Biscegli Jatene, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07678762
- Sponsor's protocol ID
- SDC 6227/25/238
- Acronym
- AnemiAI
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Prospective Study Evaluating the Accuracy of an AI-based Smartphone Application for Non-invasive Anemia Detection - AnemiAI Trial
- ClinicalTrials.gov ID
- NCT07678762
- Acronym / sponsor ID
- AnemiAI / SDC 6227/25/238
- Conditions
- Anemia (Diagnosis), Anemia
- Keywords
- Anemia, Diagnosis, AI, Artificial Inteligence
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Fabio Biscegli JateneUniversity, hospital or other
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Jul 2026 (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.
Title: Multicenter, prospective study evaluating the accuracy of an AI-based smartphone application for non-invasive anemia - AnemiAI trial Short Introduction: Anemia is a common clinical condition, often underdiagnosed, with significant impact on surgical, vulnerable, and underserved populations with limited access to laboratory testing. The NiADA technology uses artificial intelligence to estimate hemoglobin levels from images of the lower palpebral conjunctiva, offering a non-invasive, rapid, and accessible alternative to conventional diagnostics. Purpose: To evaluate the diagnostic accuracy of the NiADA application for non-invasive anemia detection, compared to the standard laboratory method (venous blood draw).
Study Design: Following informed consent, participants will undergo clinical data collection and non-invasive hemoglobin estimation using the NiADA application, operated by a trained healthcare professional. The lower palpebral conjunctiva will be imaged using a compatible smartphone camera, and the app result will be recorded immediately. Within four hours of the app assessment, a venous blood sample will be collected for laboratory hemoglobin analysis, following institutional protocols. Both results - from the app and laboratory - will be recorded on the REDCap platform. Additionally, patients will complete a brief acceptability questionnaire. Execution time, technical errors, and task completion rates will also be monitored. All centers will follow a standardized data collection protocol to ensure methodological consistency and data integrity. Study Population Sample Size (n) Adult patients (≥18 years), hospitalized or in outpatient care, with a clinical request for hemoglobin testing.
Inclusion Criteria Age ≥18 years Any gender or ethnicity Clinical indication for venous hemoglobin testing
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemoglobin detection | Active comparator | Device: AnemIA AppPatients will be tested both with the app and the gold standard test for anemia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >18 years old
- Any gender or ethnicity
- Hospitalized or outpatient
Key exclusion criteria (11 listed)
- Juandice or other yelid discoloration
- Severe skin hyperpigmentation
- Dressings, injuries or deformities at the analysis site
- Infections, trauma, or scarring on or near the eye
- Hemoglobinopathies
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 |
|---|---|---|
| AnemIA AppDetection of Anemia using an AI App | Device | Hemoglobin detection |
Primary outcome
Sensitivity and Specificity of the NiADA Smartphone Application for Detection of Anemia
Time frame: From enrollment to completion of anemia assessment (up to 1 week)
Sensitivity and specificity of the NiADA smartphone application for detecting anemia compared with laboratory hemoglobin measurement (g/dL), used as the reference standard.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AnemIA App in people with Anemia (Diagnosis) and Anemia, run by Fabio Biscegli Jatene at 1 site in Brazil.
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 3 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2026. 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 Brazil. 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?
This study is still under way. Results are not available in the source record yet.
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?
Sensitivity and Specificity of the NiADA Smartphone Application for Detection of Anemia (time frame: From enrollment to completion of anemia assessment (up to 1 week)). 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 1 Jul 2026.