| CTRI Number |
CTRI/2022/11/047758 [Registered on: 29/11/2022] Trial Registered Prospectively |
| Last Modified On: |
28/11/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
This study will collect images from ultrasound scanning in pregnant women for developing automated solutions which could later be helpful in basic screening in pregnant women. |
|
Scientific Title of Study
|
Prospective data collection of obstetric ultrasound scans for development of AI solutions |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ICBE-S-000779 v07 2022NOV08 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Suresh S |
| Designation |
Principal Investigator |
| Affiliation |
Dr. Suresh Mediscan Systems Private Limited |
| Address |
Dr. Suresh Mediscan Systems Private Limited, No. 67, 12th Avenue, Ashok Nagar, Chennai
Chennai
TAMIL NADU
600083
India |
| Phone |
09841048487 |
| Fax |
|
| Email |
ssmediscan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pallavi Vajinepalli |
| Designation |
Project Leader |
| Affiliation |
Philips Innovation Campus |
| Address |
Philips Innovation Campus, Manyata Tech Park, Nagawara
Bangalore
KARNATAKA
560045
India |
| Phone |
9986375873 |
| Fax |
|
| Email |
pallavi.vajinepalli@philips.com |
|
Details of Contact Person
Public Query
|
| Name |
Pallavi Vajinepalli |
| Designation |
Project Leader |
| Affiliation |
Philips Innovation Campus |
| Address |
Philips Innovation Campus, Manyata Tech Park, Nagawara
Bangalore
KARNATAKA
560045
India |
| Phone |
9986375873 |
| Fax |
|
| Email |
pallavi.vajinepalli@philips.com |
|
|
Source of Monetary or Material Support
|
| Bill and Melinda Gates Foundation |
|
|
Primary Sponsor
|
| Name |
Philips Research |
| Address |
Philips Research, Philips Innovation Campus, Manyata Tech Park, Nagawara (KA), 560045. |
| Type of Sponsor |
Other [Medical Device Company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India
Kenya |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Suresh S |
Dr. Suresh Mediscan Systems Private Limited |
Dr. Suresh Mediscan Systems Private Limited, No. 67, 12th Avenue, Ashok Nagar, Chennai
Chennai
TAMIL NADU |
09841048487
ssmediscan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Fetal Care Research Foundation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z34||Encounter for supervision of normal pregnancy, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
1. Female subjects, aged 18 years or more, presenting for a routine or referred ultrasound scan with:
2. A pregnancy of 7 weeks or more than 7 weeks of gestation.
3. Singleton pregnancy or multiple pregnancy
4. Normal pregnancy or abnormal pregnancy (maternal or fetal conditions)
5. Willing and able to provide informed consent |
|
| ExclusionCriteria |
| Details |
1. Pregnant women aged below 18 years.
2. Pregnancy less than 7 weeks gestation.
3. Subjects presenting with any condition that needs emergency care (as per investigator’s discretion).
4. Subject unwilling or unable to provide informed consent, such as those with neurological or psychiatric or other conditions that affect the subject’s understanding of the information provided with the consent form. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Data collected from about 500 pregnant women aged 18 years or more, with different presentations, gestational ages, placental positions, single or multiple pregnancies, growth abnormalities, abnormal umbilical artery doppler etc. |
Data collected for a period of about 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="250"
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)
|
01/12/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/12/2022 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 is a prospective data collection study. The main objective of the study is to collect ultrasound imaging data with the Lumify C5-2 ultrasound system in at least 500 pregnant women using blind and guided sweep protocols to design and develop algorithms for automated / semi-automated detection of the basic obstetric ultrasound screening parameters. To build clinically useful algorithms, the data collected is planned to represent a variety of conditions and variations seen in normal clinical practice: hence the dataset should contain at least some of the following variables such as · Different fetal positions and presentations · Different gestational ages · Different placenta locations, · Pregnancies with various amounts of amniotic fluid. · Singleton as well as multiple pregnancies. · |