| CTRI Number |
CTRI/2025/11/097616 [Registered on: 18/11/2025] Trial Registered Prospectively |
| Last Modified On: |
18/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
|
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
A multicenter, double arm clinical study to assess the safety & efficacy of “Kardiago” a handheld portable digital 10 lead simultaneous 12 channel resting ECG device against the conventional 10 lead simultaneous 12 channel resting ECG device |
|
Scientific Title of Study
|
A multicenter, double arm clinical study to assess the safety & efficacy of “Kardiago” a handheld portable digital 10 lead simultaneous 12 channel resting ECG device against the conventional 10 lead simultaneous 12 channel resting ECG device |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NLS-01 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jenny Madhuri Gudivada |
| Designation |
Professor of Cardiology |
| Affiliation |
King George Hospital |
| Address |
Department of Cardiology, King George Hospital, Maharanipeta, Visakhapatnam, Andhra Pradesh, India
Visakhapatnam
ANDHRA PRADESH
530002
India |
| Phone |
9573472413 |
| Fax |
|
| Email |
drpjennymadhuriresearch@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Suresh Jeevarathinam |
| Designation |
CEO |
| Affiliation |
Nanites Life Sciences Pvt ltd |
| Address |
Sai Ram Nivas Appartment
No.11, 17th East Street
2nd Floor, Kamaraj Nagar, Thiruvanmiyur, Chennai
Chennai
TAMIL NADU
600041
India |
| Phone |
9789606864 |
| Fax |
|
| Email |
suresh@naniteslifesciences.com |
|
Details of Contact Person
Public Query
|
| Name |
Prathap Vasu C |
| Designation |
Managing Director |
| Affiliation |
Clinexiz |
| Address |
Door No-2211,2/1149,,I 100
Hilite Business Park,Kozhikode,Kerala
Kozhikode
KERALA
673017
India |
| Phone |
9207603026 |
| Fax |
|
| Email |
clinexiz.india@gmail.com |
|
|
Source of Monetary or Material Support
|
| NANITES LIFE SCIENCES PVT LTD |
|
|
Primary Sponsor
|
| Name |
NANITES LIFE SCIENCES PVT LTD |
| Address |
IInd Floor, D.No 11 17TH East Street, Sri Ramnivas Apartments, Flat No.S-1, Kamaraj Nagar, Thiruvanmiyur, Chennai, Tamil Nadu 600041 |
| Type of Sponsor |
Other [DEVICE MANUFATCURER] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Paidi Suresh Kumar |
Visakha Institute of Medical Sciences |
Department of Cardiology, Visakha Institute of Medical Sciences,Hanumanthavaka, Chinnagadhili,Visakhapatnam-530040
Visakhapatnam
ANDHRA PRADESH |
9866311341
drpsureshkumarresearch@gmail.com |
| Dr Jenny Madhuri Gudivada |
King George Hospital |
Department of Cardiology, King George Hospital, Maharanipeta, Visakhapatnam, Andhra Pradesh, India-530002
Visakhapatnam
ANDHRA PRADESH |
9573472413
drjennymadhuriresearch@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| IEC KING GEORGE HOSPITAL |
Submittted/Under Review |
| IEC Visakha Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Subjects of age between 18 to 60. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
12 CHANNEL ECG |
APPROVED BY ANY STANDARD USFDA APPROVED DEVICE MANUFACTURER |
| Intervention |
KARDIAGO |
Handheld portable 10 lead Simultaneous 12 Channel Resting Digital ECG |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects of age between 18 to 60.
2.For whom the Investigator considers that the compliance will be correct.
3.Cooperating, informed of the need and duration of the study, and ready to comply with protocol procedures.
4.Having signed a Consent Form and will be once informed orally and in writing of all information concerning the study procedures and study objectives.
5. Volunteers with any cardiac abnormalities or ailments or abnormal blood pressure, with pacemaker implants can be included.
|
|
| ExclusionCriteria |
| Details |
1.Known sensitivity to the investigational product. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary endpoint of the study would be the efficacy of the IP which will be assessed by assessing the ECG results from Investigational Product and comparative product |
VISIT 2 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The Secondary end-points of this study would be safety and adverse events |
VISIT 2 |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
10/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
main purpose of the study is to prove efficacy of Kardiago ECG Machine. Subjects
recruited are screened and recruited to participate in the study. Informed
consent will be obtained before undertaking any study related procedures. The subjects will visit their designated
study site on following 2 different occasions. The screening includes general
check for inclusion and exclusion criteria.
If
the subject satisfies the screening tests and other inclusion/ exclusion
criteria, he/she is recruited into the trial. On visit two ECG test will be
done in subjects using Investigational Product and then with comparative product
- Visit
1 (Screening & Randomisation/Day)
- Visit
2 (Baseline/Day 1)
PRIMARY
OBJECTIVE
Primary
objective of the study is to evaluate the efficacy of Kardiago ECG machine when
compared with the comparative product.
SECONDARY
OBJECTIVE: Secondary objective is to assess the safety of Kardiago ECG machine,
when used in human. |