Evaluation of AGM100 Pulmonary Gas Exchange Monitor in Clinical Use in Indian Population

Evaluation of AGM100 Pulmonary Gas Exchange Monitor in Clinical Use - nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2026/01/100508

Enrollment

Registered

2026-01-07

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

Health Condition 1: J060- Acute laryngopharyngitis Health Condition 2: J18- Pneumonia, unspecified organism

Interventions

Intervention1: Medipines AGM100: The MediPines AGM100 is the first non-invasive pulmonary gas exchange analyzer.By providing instantaneous gas exchange measurements, physicians can assess and manage c

Eligibility

Inclusion criteria

Inclusion criteria: Healthy volunteers and patients with specific conditions like Pneumonia and COPD patient Willingness to provide informed consent

Exclusion criteria

Exclusion criteria: Pregnant individuals Participants with implanted electronic medical devices Severe skin conditions interfering with sensor application

Design outcomes

Primary

Measure	Time frame
The sample size was calculated based on the primary outcome of agreement between non-invasive estimation of arterial oxygen partial pressure(PaO2) obtained using AGM100 and PO2 measures by Arterial Blood Gas(ABG) analysis.Assuming acceptable limits of agreement of +-10 mmHg,a 95% confidence level, and adequate precision for Bland-Altman analysis,the minimum required sample size was calculated to be 30 participants,accounting for measurement variabillity and technical exclusion.Timepoint: Single time point with simultaneous measurement of non-invasive PaO2 using AGM100 and PO2 measured by Arterial Blood Gas(ABG) during the same clinical encounter.	—

Measure

Time frame

The sample size was calculated based on the primary outcome of agreement between non-invasive estimation of arterial oxygen partial pressure(PaO2) obtained using AGM100 and PO2 measures by Arterial Blood Gas(ABG) analysis.Assuming acceptable limits of agreement of +-10 mmHg,a 95% confidence level, and adequate precision for Bland-Altman analysis,the minimum required sample size was calculated to be 30 participants,accounting for measurement variabillity and technical exclusion.Timepoint: Single time point with simultaneous measurement of non-invasive PaO2 using AGM100 and PO2 measured by Arterial Blood Gas(ABG) during the same clinical encounter.

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Secondary

Measure	Time frame
Secondary outcomes include assessment of correlation between non-invasive arterial oxygen partial pressure(PaO2) estimated using AGM100 & PO2 measured by Arterial Blood Gas (ABG) analysis,evaluation of measuremen bias across different levels of oxygenation,assessment of variability in PaO2 differences & feasibility of obtaining non-invasive measurements during routine clinical assessment.Timepoint: Single time point assessed concurrently with the primary outcome,with non invasive PaO2 measurement using AGM100 & Po2 measured by ABG during same clinical encounter	—

Measure

Time frame

Secondary outcomes include assessment of correlation between non-invasive arterial oxygen partial pressure(PaO2) estimated using AGM100 & PO2 measured by Arterial Blood Gas (ABG) analysis,evaluation of measuremen bias across different levels of oxygenation,assessment of variability in PaO2 differences & feasibility of obtaining non-invasive measurements during routine clinical assessment.Timepoint: Single time point assessed concurrently with the primary outcome,with non invasive PaO2 measurement using AGM100 & Po2 measured by ABG during same clinical encounter

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Countries

India

Contacts

Public ContactOjasavi Nirav

Stage021 Medical Device OPC PVT LTD

shailendram@stage021.com7387596665

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026