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Comparing a New Blood Monitoring Device with Standard Laboratory Tests

Validation Study Comparing A Novel Non-Invasive Spectroscopic Device with Laboratory Methods for Measuring RBC, WBC, Platelets and Hemoglobin in Adult and Pediatric Patients A Prospective Observational study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/12/098493
Enrollment
142
Registered
2025-12-04
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Z00-Z99- Factors influencing health status and contact with health services

Interventions

Intervention1: Nil: Nil

Sponsors

Sriram R
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Paediatric patients aged 24 months to 17 years and adult patients aged 18 to 75 years. Undergoing treatment that requires routine monitoring of blood parameters (e.g., chemotherapy, hematologic conditions). Receiving care at participating hospital sites (inpatient or outpatient). Able to provide informed consent (or assent with guardian consent for minors). Willing to undergo non-invasive device based measurements during scheduled clinical visits

Exclusion criteria

Exclusion criteria: Severe cognitive or behavioural impairments that prevent cooperation during brief non invasive assessments. Enrolment in another clinical study that may confound blood monitoring outcomes. Individuals (or guardians, in case of minors) who decline to provide informed consent

Design outcomes

Primary

MeasureTime frame
Concordance between device readings and laboratory CBC values Accuracy across paediatric and adult groups Usability and patient comfort (end of study questionnaire) Timepoint: 0th, 1st and 2nd hour

Secondary

MeasureTime frame
Feasibility of device for point-of-care monitoring Suitability of data for AI-based trend prediction Rate of successful usable readings Completeness & consistency of collected data Timepoint: 0th, 1st, 2nd hour

Countries

India

Contacts

Public ContactDr Vasudeva Bhat K

Kasturba Medical College, Manipal

vasudev.bhat@manipal.edu9619114703

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026