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CTRI Number  CTRI/2022/11/047315 [Registered on: 15/11/2022] Trial Registered Prospectively
Last Modified On: 05/11/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Observational 
Study Design  Other 
Public Title of Study   Ultrasound Study– Reliance Diagnostic 
Scientific Title of Study   Philips Ultrasound Study Protocol – Reliance Diagnostic 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
11554  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Tanuj Garg 
Designation  Consultant Radiologist 
Affiliation  Reliance Diagnostic 
Address  Indra Chowk, Hapur Road, SH 18, Meerut

Meerut
UTTAR PRADESH
25002
India 
Phone  9837072571  
Fax    
Email  tanuj1967@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Tanuj Garg 
Designation  Consultant Radiologist 
Affiliation  Reliance Diagnostic 
Address  Indra Chowk, Hapur Road, SH 18, Meerut


UTTAR PRADESH
25002
India 
Phone  9837072571  
Fax    
Email  tanuj1967@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Mr Hasan Ali Ahmed 
Designation  Director 
Affiliation  Xplora Clinical Research Services Pvt. Ltd 
Address  No. 252, 13th Cross, Wilson Garden, Bangalore

Bangalore
KARNATAKA
560027
India 
Phone  9886012598  
Fax    
Email  hasan@xplorahealth.com  
 
Source of Monetary or Material Support  
Philips Ultrasound, Inc. 22100 Bothell-Everett Hwy Bothell, WA 98021 
 
Primary Sponsor  
Name  Philips Ultrasound, Inc. 
Address  22100 Bothell-Everett Hwy Bothell, WA 98021 
Type of Sponsor  Other [Non-Pharmaceutical Company] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Tanuj Garg  Reliance Diagnostic  Room No. 1, Division 1, Department-Ultrasound, Indra Chowk, Hapur Road, SH 18, Meerut, Uttar Pradesh - 25002
Meerut
UTTAR PRADESH 
9837072571

tanuj1967@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Subharti Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Ultrasound Scanning 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Subject (or legal representative where appropriate) is willing and capable of providing informed consent and physically capable of performing study related activities.
2. Subject is indicated for a routine ultrasound exam at the site, including with or without examination with contrast. 
 
ExclusionCriteria 
Details  1. Subjects with any known contraindications for ultrasound scanning.
2. Philips employees and their family members.
3. Subjects under 18 years of age 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The feedback obtained during the study will be used to guide product optimization and development. No
statistical analysis will be conducted, as the study evaluates user preference. Data may be collected to
validate user needs for final product designs. 
1 day 
 
Secondary Outcome  
Outcome  TimePoints 
Not Applicable  Not Applicable 
 
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   N/A 
Date of First Enrollment (India)   21/11/2022 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
This study is being conducted to assess or demonstrate both investigational and cleared ultrasound systems in human subjects. All scanning under this protocol is non-diagnostic and will be conducted using the ALARA principle to ensure the safety of the subjects. The objective of this study is to support ultrasound scanning activities in human subjects that assesses modifications to product design and development, and user preference evaluations. Data may be collected to validate user needs for final product designs. There are no formal endpoints, as the study is not being used to test for safety and efficacy. The study is intended to gather customer feedback on the ultrasound system to guide product development. This is a prospective, non-significant risk, non-randomized, single/multiple visit clinical study of subjects who provide written consent. Subjects are scanned using an investigational or cleared ultrasound system. After scanning is complete, their study obligations are over. No follow up is conducted. Up to 200 subjects per year for 2 years. As ultrasound imaging is based on non-ionizing radiation, it is generally considered safe when used by appropriately trained health care providers. The feedback obtained during the study will be used to guide product optimization and development. No statistical analysis will be conducted, as the study evaluates user preference. 
In some subjects, the use of an ultrasound contrast agent (UCA) may be required for the ultrasound scan performed as part of routine care. In these subjects, the contrast agent may also be used for the study required ultrasound scan. Adverse events and adverse reactions related to the UCA are not considered study related adverse events. If a UCA is used it should be used in compliance with the approved indications and labeling, and the total amount of contrast administered to a subject shall be limited per the labelling of the UCA and at the discretion of the Investigator.
 
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