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CTRI Number  CTRI/2020/06/025595 [Registered on: 04/06/2020] Trial Registered Prospectively
Last Modified On: 29/02/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   prospective and non-randomized 
Study Design  Other 
Public Title of Study   A prospective, non-randomized, clinical study evaluating MR with volunteers  
Scientific Title of Study   Philips Magnetic Resonance Study Protocol — Human Volunteer Scanning for System Feasibility, Optimization, Demonstration and Education 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Ms. Alagammai Ramanathan 
Designation  Specialist II-Clinical Application 
Affiliation  Philips India Limited,  
Address  MRI Department, Room Number: MRBANTB01, MRBANTB02, MRBANTB03, MRBANTB04 & MRBANTB05 Embassy Business hub, Khata No.1368 25 2 25 3, Venkatala Village, Bangalore North Taluk, Bangalore -560064

Bangalore
KARNATAKA
560064
India 
Phone  08884722789  
Fax    
Email  alagammai.ramanathan@philips.com  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Ms. Alagammai Ramanathan 
Designation  Specialist II-Clinical Application 
Affiliation  Philips India Limited,  
Address  MRI Department, Room Number: MRBANTB01, MRBANTB02, MRBANTB03, MRBANTB04 & MRBANTB05 Embassy Business hub, Khata No.1368/25/2/25/3, Venkatala Village, Bangalore North Taluk, Bangalore -560064

Bangalore
KARNATAKA
560064
India 
Phone  08884722789  
Fax    
Email  alagammai.ramanathan@philips.com  
 
Details of Contact Person
Public Query  
Name  MrHasan Ali 
Designation  Director 
Affiliation  Xplora Clinical Research Services Private Ltd. 
Address  Xplora Clinical Research Services Private Ltd. Department of Clinical Operation #252, 13th Cross, Wilson Garden, Bangalore 560027
Xplora Clinical Research Services Private Ltd. Department of Clinical Operation #252, 13th Cross, Wilson Garden, Bangalore 560027
Bangalore
KARNATAKA
560027
India 
Phone  080-42115562  
Fax    
Email  hasan@xplorahealth.com  
 
Source of Monetary or Material Support  
Philips India Ltd Philips Innovation Campus, MFAR Manyata Tech Park,Nagawara, Bangalore -560045 Karnataka, India 
 
Primary Sponsor
Modification(s)  
Name  Philips India Limited 
Address  Philips Innovation Campus, Embassy Business hub, Khata No.1368/25/2/25/3, Venkatala Village, Bangalore North Taluk, Bangalore -560064  
Type of Sponsor  Other [Sponsor-Non Pharmaceutical company] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pradeep S Moghe  Dr Moghe Laboratory  Flat No.- 3, Motiram Complex, Survey No. 81, Opp. Kachara Depot, Paud Rd. Pune-411038, Maharashtra, India.
Pune
MAHARASHTRA 		 9423585661

pradeepmoghe@yahoo.co.in 
Mr Pankaj Dilip Jaiswal  Philips GBS LLP   Philips Healthcare Innovation Campus, Plot No. B-79, Chakan Phase 2, MIDC Industrial Area, Pune -410501, Maharashtra, India
Pune
MAHARASHTRA 		 9099060279

pankaj.jaiswal@philips.com 
Ms Alagammai Ramanathan  Philips India Ltd  Philips India Ltd Philips Innovation Campus, Embassy Business hub, Khata No.1368/25/2/25/3, Venkatala Village, Bangalore North Taluk, Bangalore -560064
Bangalore
KARNATAKA 		 8884722789

alagammai.ramanathan@philips.com 
Dr Dinesh S  Prima diagnostics  4/16, 9th Main, 3rd Block, Opp to Jos Alukkas & Next to Jain University, Jayanagar, Bangalore- 560011, Karnataka, India
Bangalore
KARNATAKA 		 9886125229

bhaktha.dinesh@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
ACE Independent Ethics Committee  Approved 
ACE Independent Ethics Committee  Approved 
Skinovate Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  MRI Imaging Study in Healthy Human Volunteer 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1) Volunteeris willing and capable of providing informed consent and physically capable of performing study related activities.
2) Volunteer age between 18 -65 years old including either sex.
3) Volunteer has passed a general medical health check which involves laboratory investigations like CBC, ESR,RBS, Serum Creatinine, HIV, HbsAg, HCV, Urine analysis, ECG and UPT( for child bearing potential female subjects only). 
 
ExclusionCriteria 
Details  1) Volunteers with any known contraindications for MR scanning
2) Volunteers with Pacemakers or other implanted electronic devices which are Non MR Compatible
3) Volunteers with metal implants which are not MR conditional or MR safe
4) Volunteers with small metal components in the body (vascular clips, metal splinters, stents, etc.) which are not MR conditional or MR safe
5) Volunteers with epilepsy
6) Volunteer with known severe cardiac disorders, Cerebrovascular, Respiratory, Hepatic, Renal, or Congenital anomaly or any other conditions as per the Physician opinion
7) Volunteers with uncontrolled hyper tension and diabetic Mellitus
8) Volunteers with dermal medicinal patches
9) Volunteers with mental illness or diseases, known claustrophobia, anxiety or panic disorders
10) Volunteers with Meniere’s disease or any previous history of tinnitis
11) Pregnant women
12) Volunteers with significant chronic illness 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
There is no formal endpoint, as the study is not being conducted to test for safety and efficacy.  There is no formal endpoint, as the study is not being conducted to test for safety and efficacy.  
 
Secondary Outcome  
Outcome  TimePoints 
There is no formal endpoint, as the study is not being conducted to test for safety and efficacy.  There is no formal endpoint, as the study is not being conducted to test for safety and efficacy. 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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   N/A 
Date of First Enrollment (India)   05/06/2020 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  		 This study is being conducted to generate data for product feasibility and development, product verification and validation, research and development, marketing purposes, image optimization, troubleshooting and demonstration of Philips MR devices, including the education of personnel.All scanning under this protocol is non-diagnostic and done on Philips controlled / owned (test) equipment and locations.

The data is used for optimize, verify and validate technical performance. The studies will not generate any data that can validate clinical/diagnostic -performance or -claims.

There is no formal endpoint, as the study is not being conducted to test for safety and efficacy. However this study protocol will be revised every 3 years.

This is prospective, non-randomized, clinical study evaluating MR with volunteers who provide written informed consent. Eligible volunteers participate in sessions within the MR environment which may include scanning using an investigational or regulatory cleared MR system by a Qualified MR operator. A session may also involve use of regulatory MR accessories with or without scanning. No follow up is conducted after a session.

Population: Up to 300 Healthy volunteers per year. 

Study Centers: 
All the Volunteers will be screened at Prima Diagnostic center by Co Investigator Dr Dinesh. S and MRI Imaging will be carried out at Philips India Limited by PI Mr Zainudeen Kallumpurath. 


Details of Amended Protocol version No. 2.0

Study Duration

Inclusion Criteria

Additional Site

Informed Consent Document

Summary of Changes

ü  In the previous version No. 1.1, it was mentioned as - It is recommended that the number of visits is limited to a maximum of 12 per year and with a minimum of 4 weeks gap between visits.

ü  In the current version No. 2.0, this section is updated as - The interval between visits should be at least 2 weeks.

ü  In the previous version No. 1.1, it was mentioned as – Volunteer has passed a general medical health check which involves laboratory investigations like CBC, ESR, RBS, Serum Creatinine, HIV, HbsAg, HCV, Urine analysis, ECG and UPT (for child bearing potential female subjects only.)

ü  In the current version No. 2.0, this section is updated as- Volunteer has passed a general medical health check.

ü  Additional Site details: Philips GBS LLP

Plot No. B 78 – 79, Chakan Phase-2, MIDC Industrial Area, Maharashtra, India

 

ü  Site specific Informed Consent Document added in amended protocol version no. 2.0, dated 28 Jul 2023.

ü  Summary of changes for protocol version no. 2.0, dated 28 Jul 2023 is updated.

ü  Also, received approval for the same form the Ethics Committee and uploaded in the CTRI portal.

 

Details of Amended Protocol version No. 2.1

Administrative Change

Change of Principal Investigator

Informed Consent Document

Summary of Changes

ü  In the previous version No. 2.0, it was reed as

- Philips India Ltd

Philips Innovation Campus, MFAR Manyata Tech Park, Nagawara, Bangalore-560045, India

ü  In the current version No. 2.1, in this it is added as –

-Philips Innovation Campus,

Embassy Business hub, Khata No.1368/25/2/25/3, Venkatala Village, Bangalore North Taluk, Bangalore -560064

ü  In the previous version No. 2.0, it was read as –

Principal Investigator Signature was signed by Mr. Zainudeen Kallumpurath

ü  In the current version No. 2.1, in this it is added as –

Principal Investigator Signature is signed by Ms. Alagammai Ramanathan

ü  Amended protocol Site Specific Informed Consent Document version no. 2.1, dated 01 Feb 2024 is updated.

ü  Summary of changes for protocol version no. 2.1, dated 15 Feb 2024 is updated.

 


 
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