| CTRI Number |
CTRI/2019/09/021462 [Registered on: 30/09/2019] Trial Registered Prospectively |
| Last Modified On: |
08/09/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
data collection study |
| Study Design |
Other |
|
Public Title of Study
|
A data collection study to improve the speed and ease of use when performing ultrasound scanning of the heart of babies in pregnant women. |
|
Scientific Title of Study
|
Fetal Heart Ultrasound Imaging – Prospective data collection of normal and abnormal cases |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PJ-006563 v1.0 date 04jun2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Suresh S |
| Designation |
Director, Mediscan Systems , Chennai, India |
| Affiliation |
Mediscan Systems , Chennai, India |
| Address |
Mediscan systems, No. 197, Dr. Natesan Road, Mylapore, Chennai 600004, India
Chennai
TAMIL NADU
600004
India |
| Phone |
9841048487 |
| Fax |
|
| Email |
ssmediscan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pallavi Vajinepalli |
| Designation |
Principal scientist and team leader |
| Affiliation |
Philips India Ltd |
| Address |
Philips Research Bangalore India,
Philips Innovation Campus
Manyata Tech Park, Nagavara, Bangalore
Bangalore
KARNATAKA
560045
India |
| Phone |
|
| Fax |
|
| Email |
pallavi.vajinepalli@philips.com |
|
Details of Contact Person
Public Query
|
| Name |
Pallavi Vajinepalli |
| Designation |
Principal scientist and team leader |
| Affiliation |
Philips India Ltd |
| Address |
Philips Research Bangalore India,
Philips Innovation Campus
Manyata Tech Park, Nagavara, Bangalore
Bangalore
KARNATAKA
560045
India |
| Phone |
|
| Fax |
|
| Email |
pallavi.vajinepalli@philips.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Philips India Ltd |
| Address |
Philips India Ltd, Philips Research Bangalore India,
Philips Innovation Campus
Manyata Tech Park, Nagavara, Bangalore
|
| Type of Sponsor |
Other [medical/lifestyle device company] |
|
|
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 Suresh S |
Mediscan systems |
Ground floor, Fetal Eco Department, Mediscan systems, 197, Doctor Natesan Road, Mylapore, Chennai, Tamil Nadu – 600004, India
Chennai
TAMIL NADU |
919841048487
ssmediscan@gmail.com |
| Dr Nitin G Chaubal |
Thane ultrasound centre |
Thane ultrasound centre, Shanti Niwas Dr Moose Road Talaopali Thane W, Thane, Maharashtra – 400601, India
Thane
MAHARASHTRA |
919619072238
thaneultrasound@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| IEC@IISS is an Independent Ethics Committee promoted by International Institute of Sleep Sciences, Thane (W) Mumbai, India, 400602 |
Approved |
| Independent Ethics Committee, Fetal Care Research Foundation 197 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Any indication for an obstetric ultrasound scan. |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Female patients, aged 18 years or more, presenting for a routine or referred US scan with:
A pregnancy equal or above 17 weeks of gestation
Singleton pregnancy or multiple pregnancy
Normal pregnancy or abnormal pregnancy (maternal or fetal conditions)
Willing and able to provide informed consent |
|
| ExclusionCriteria |
| Details |
Subject aged below 18 years.
Subject with a pregnancy younger than 17 weeks.
Subjects (mothers) presenting with fever or hemorrhagia or any condition that needs emergency care (as per investigator’s discretion).
Subject (mother) with neurological or psychiatric disorders or other disorders that affect the subject’s understanding of the information provided with the consent form.
Subject unwilling or unable to provide informed consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
100 subjects with data validated by the sponsor have been enrolled at each site (including 10 abnormal fetal hearts) or we have reached a number of samples that have allowed the development of algorithms sufficiently accurate to be tested in a validation study.
|
Estimated completion date: 28th February 2019 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
nil |
|
|
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 |
|
Date of First Enrollment (India)
|
03/10/2019 |
| 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)
|
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
|
|
This
study is a prospective data collection study.
The
main objective of the study is to collect DICOM ultrasound imaging data in
200 fetuses with normal or abnormal fetal heart to design and develop
algorithms for automated/semi-automated fetal heart ultrasound assessment.
The
data collection will be done at two independent clinical sites with
non-competitive recruitment (100 subjects total at each centre including 10
abnormal fetal hearts). Both centres: Mediscan systems, Chennai and Thane
Ultrasound centre, Mumbai, are referral diagnostic ultrasound centres in
India.
Data
collection will be done on the commercial registered ultrasound devices of
the centre (Philips Affiniti 70, Philips Epiq 5 or 7) and one commercially
released ultrasound device from the sponsor (Philips Affiniti 70 at Mediscan
systems only) and will be used within the intended use.
The
end-point of the study will be reached when the data from the 200 ultrasound
scans has been collected and transferred to the Sponsor after
de-identification.
|
|