| CTRI Number |
CTRI/2026/01/100508 [Registered on: 07/01/2026] Trial Registered Prospectively |
| Last Modified On: |
29/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Diagnostic
Other (Specify) [Validation Study] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Evaluation of AGM100 Pulmonary Gas Exchange Monitor in Clinical Use in Indian Population |
|
Scientific Title of Study
|
Evaluation of AGM100 Pulmonary Gas Exchange Monitor in Clinical Use |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vijay Kumar Chennamchetty |
| Designation |
MD (Pulmonology) IDCC (Critical Care) FSM (Sleep Medicine) FCCP | Pulmonology |
| Affiliation |
Apollo Hospitals Jubilee Hills Hyderabad |
| Address |
Apollo Hospitals Jubilee Hills Hyderabad Pulmonary Department Room no 2 City Apollo Health Street Jubilee Hills Hyderabad Telangana 500033
Hyderabad
TELANGANA
500033
India |
| Phone |
9701297721 |
| Fax |
|
| Email |
drvizae@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shailendra Mishra |
| Designation |
Director |
| Affiliation |
Stage021 Medical Device OPC PVT LTD |
| Address |
1153 4 Near Huda Market Sector 4Gurugram
Gurgaon
HARYANA
122001
India |
| Phone |
7387596665 |
| Fax |
|
| Email |
shailendram@stage021.com |
|
Details of Contact Person
Public Query
|
| Name |
Ojasavi Nirav |
| Designation |
Product Specialist |
| Affiliation |
Stage021 Medical Device OPC PVT LTD |
| Address |
Aashiyana Homes Tower no 8 flat no 401 Noida sec 70
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9718374998 |
| Fax |
|
| Email |
ojasavi.n@stage021.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Stage021 Medical Device OPC PVT LTD |
| Address |
Unit 264 2st Floor 19D Palm Beach Rd Juhu Nagar Phase 2 Sector 14 Vashi Navi Mumbai Maharashtra 400703 |
| Type of Sponsor |
Other [MEDICAL DEVICE ] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| MediPines Corporation |
MediPines Corporation, 22815 Savi Ranch Parkway, Suite E, Yorba Linda, CA 92887,
Country: United States Telephone No.: 949 398 4670 FAX: 949 398 4670 E-Mail :
contact@medipines.com |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vijay Kumar Chennamchetty |
Apollo Hospitals Jubilee Hills Hyderabad |
Apollo Hospitals Jubilee Hills Hyderabad Pulmonary Department Room no 2 City Apollo Health Street Jubilee Hills Hyderabad Telangana 500033
Hyderabad
TELANGANA |
9701297721
drvizae@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| InstitutionalEthicsCommitteeClinicalStudies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J060||Acute laryngopharyngitis, (2) ICD-10 Condition: J18||Pneumonia, unspecified organism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
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 cardiorespiratory function of their patients much more accurately. The AGM100 measures critical parameters, such as blood and alveolar oxygen levels, with accuracy comparable to arterial blood gas (ABG) measurements. |
| Comparator Agent |
Standard ABG |
Subject shall undergo the Standard ABG |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Healthy volunteers and patients with specific conditions like Pneumonia and COPD patient
Willingness to provide informed consent
|
|
| ExclusionCriteria |
| Details |
Pregnant individuals
Participants with implanted electronic medical devices
Severe skin conditions interfering with sensor application
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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. |
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. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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. |
Single time point assessed concurrently with the primary outcome,with non invasive PaO2 measurement using AGM100 & Po2 measured by ABG during same clinical encounter |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
15/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/01/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study evaluates the AGM100 Pulmonary Gas Exchange Monitor, a novel non-invasive device designed to assess gas exchange efficiency at the bedside The AGM100 estimates variables such as Oxygen Deficit and estimated arterial oxygen pressure PaO2 by analyzing end-tidal CO2 and oxygen saturation, providing real time insights into pulmonary function without the need for arterial blood gas sampling. This technology is particularly valuable in managing patients with non-ventilated respiratory conditions such as COVID 19, pneumonia, and chronic obstructive pulmonary disease COPD. These patients often experience impaired oxygenation due to ventilation-perfusion mismatch or diffusion abnormalities. The AGM100 enables clinicians to detect these gas exchange deficits early, helping guide oxygen therapy and escalation of care decisions. In COVID 19 and pneumonia, where patients may appear clinically stable despite underlying hypoxemia silent hypoxia the AGM100 offers a non-invasive method to track deterioration. In COPD patients, it assists in evaluating the effectiveness of bronchodilators, supplemental oxygen, or identifying exacerbations without invasive monitoring. Clinicians reported that the AGM100 is easy to use and integrates well into clinical workflows, offering a promising tool for enhancing patient care in both acute and chronic respiratory conditions.
|