| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Ultrasound Scanning |
|
|
Intervention / Comparator Agent
|
|
|
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. |