| CTRI Number |
CTRI/2018/07/014750 [Registered on: 05/07/2018] Trial Registered Prospectively |
| Last Modified On: |
15/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [open label] |
| Study Design |
Other |
|
Public Title of Study
|
MRI scanning for design and development activities |
|
Scientific Title of Study
|
Scanning of subjects on in-house MRI systems ≤ 3.0T for the inspection of Image quality and validation of new software enhancements and features. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Zainudeen Kallumpurath |
| Designation |
Senior Specialist Clinical Applications |
| Affiliation |
Philips India Limited |
| Address |
Philips Innovation Campus,
Manyata Tech Park,
Nagawara.
Bangalore
KARNATAKA
560045
India |
| Phone |
|
| Fax |
|
| Email |
zainudeen.kp@philips.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jaladhar Neelavalli |
| Designation |
Senior Specialist Clinical Science |
| Affiliation |
Philips India Limited |
| Address |
Philips Innovation Campus,
Manyata Tech Park,
Nagawara.
Bangalore
KARNATAKA
560045
India |
| Phone |
|
| Fax |
|
| Email |
jaladhar.neelavalli@philips.com |
|
Details of Contact Person
Public Query
|
| Name |
Ravikumar KL |
| Designation |
Clinical Research Coordinator |
| Affiliation |
T-Cell Gene |
| Address |
T-Cell Gene
No.7/9
out house 30th cross,
4th block,
Jayanagar,
Bangalore
Bangalore
KARNATAKA
560001
India |
| Phone |
|
| Fax |
|
| Email |
ravikumarkl@gmail.com |
|
|
Source of Monetary or Material Support
|
| Philips India Limited,
Philips Innovation Campus,
Manyata Tech Park,
Nagawara,
Bangalore - 560032
India.
Phone: 91-80-41890000 |
|
|
Primary Sponsor
|
| Name |
Philips India Limited |
| Address |
Philips Innovation Campus,
Manyata Tech Park,
Nagawara,
Bangalore,
PIN code: 560045 |
| Type of Sponsor |
Other [Research and development center] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Zainudeen Kallumpurath |
Philips Innovation Campus |
Manyata Tech Park,
Nagawara,
Karnataka.
Bangalore
KARNATAKA |
9901899225
zainudeen.kp@philips.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sree Venkateshwara Speciality Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MRI Scanner |
1. Enrolled volunteer will undergo MRI scanning session of 1 hour.
2. The scans are performed to access the MRI scanners imaging quality and these scans are not targeted for any disease condition.
3. No intravenous or oral contrast media will be used in this study.
4. No drug will be used in this study. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Participant is willing and able to give informed consent for participation in the study.
2. Participant is Healthy Male or Female, aged 18 years or above.
3. Participant has clinically acceptable laboratory
ECG
Chest X-ray
physical health (in the Investigators opinion) and willing to comply with all study requirements.
4. Volunteers’ Participant shall not have any condition that are contra-indicated for undergoing MRI Scanning.
5. Participant is willing to allow his or her general practitioner and consultant, if appropriate, to be notified of participation in the study.
|
|
| ExclusionCriteria |
| Details |
The participant may not enter the study if ANY of the following apply:
1. Participant with any non-MR compatible implants or metallic foreign bodies, (Example: piercings, metal clips, surgical implants, pacemakers etc.)
2. Female participants who are pregnant, lactating or planning pregnancy during the course of the study.
3. Participants with significant renal, cardiac or hepatic impairment.
4. Participants with scheduled elective surgery or other procedures requiring general anesthesia during the study.
5. Participant who is terminally ill.
6. Participants who have participated in another research study involving an investigational product in the past 12 weeks.
7. Participants with Tattoos, permanent make up, Claustrophobia, anxiety or panic disorders, Epilepsy, and Meniere’s disease.
8. Participants with any other significant disease or disorder, which, in the opinion of the Investigator, may put the participants at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study.
9. Participants with any other condition as deemed unsuitable by the Medical Advisor.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| MRI System related adjustments |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Optimization of image quality and their preset settings |
6 months |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
10/07/2018 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Philips Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.This MR system enables trained physicians to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation, representing the spatial distribution of protons or other nuclei with spin.
Philips Healthtech is a leading provider of MRI systems and solutions. This study is intended to maintain or enhance the reliability, performance, workflows and clinical acceptance of these MRI solutions. |