| CTRI Number |
CTRI/2025/12/099233 [Registered on: 16/12/2025] Trial Registered Prospectively |
| Last Modified On: |
16/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
A Clinical Investigation study to assess the performance of the investigational Philips Obstetric Application suite |
|
Scientific Title of Study
|
iMAMA Feasibility Study Protocol- India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol ID : 301016, version 1.0, Version date : 22-04-2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arul Dasan |
| Designation |
Professor & Unit Chief, Head of Vanivilas Hospital Radiology Department |
| Affiliation |
Bangalore Medical College & Research Institute |
| Address |
Radiodiagnosis department, Victoria Hospital Compound, Sultan Rd, Kalasipalya, Bengaluru
Bangalore
KARNATAKA
560002
India |
| Phone |
9739312244 |
| Fax |
|
| Email |
arul_dsn@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Madhumita Gupta |
| Designation |
Senior Scientist - Clinical |
| Affiliation |
PHILIPS INDIA LIMITED |
| Address |
Philips Innovation Campus, Embassy Business Hub, R T Nagar, Venkatala, Bengaluru, Karnataka –560064
Bangalore
KARNATAKA
560064
India |
| Phone |
9900568016 |
| Fax |
|
| Email |
madhumita.gupta@philips.com |
|
Details of Contact Person
Public Query
|
| Name |
Vijendra Singh Mandloi |
| Designation |
Specialist 2 |
| Affiliation |
PHILIPS INDIA LIMITED |
| Address |
Philips Innovation Campus, Embassy Business Hub, R T Nagar, Venkatala, Bengaluru, Karnataka –560064
Bangalore
KARNATAKA
560064
India |
| Phone |
9986904315 |
| Fax |
|
| Email |
vijendra.singh.mandloi@philips.com |
|
|
Source of Monetary or Material Support
|
| Philips India Limited, 4A, 5th floor,
Rajarhat, Ecospace Business Park Premises, AAII, newtown Chakpachuria, Kolkata, West Bengal 700156, India |
|
|
Primary Sponsor
|
| Name |
Philips India Limited |
| Address |
Rajarhat, 4A, 5th floor, Ecospace Business Park Premises, AAII, newtown Chakpachuria, Kolkata, West Bengal 700156, India |
| Type of Sponsor |
Other [Medical Device Manufecturer] |
|
|
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 Arul Dasan |
Vanivilas Hospital |
Radiodiagnosis Department, Victoria Hospital Compound, K R Rd, Kalasipalya, Bengaluru, Karnataka 560002
Bangalore
KARNATAKA |
9739312244
arul_dsn@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of Bangalore Medical College and Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O998||Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Philips Lumify C5-2 Ultrasound |
This is a released system that will be used by an expert user to generate Ground truth data which will be used to compare the results obtained from the research application.
Duration: 20 mins |
| Intervention |
Philips Obstetrics Application Suite mobile application |
The above application will be used by healthcare professionals to acquire an exam the results of which will be compared against the ground truth data.
Duration: 20 mins |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant Participants:
Subjects will be enrolled based on these inclusion/exclusion criteria. The Principal
Investigator/designated study personnel are responsible for screening all subjects to determine the
eligibility for participation.
1 Female subjects aged 18 years or older recruited for a research ultrasound scan.
2 A pregnancy of 14 weeks or more than 14 weeks of gestation.
3 Subject willing and capable of providing informed consent and physically capable of performing study related activities.
Non-Expert Users:
Inclusion Criteria
1 Participants >18 years of age.
2 Certified healthcare professionals (CHP) with OB patient management experience.
3 Participants are able and willing to provide written informed consent. |
|
| ExclusionCriteria |
| Details |
1 Subjects presenting with any condition that needs emergency care (as per investigators discretion).
2 Subject unwilling to provide informed consent.
3 Subject 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.
4 Philips employees.
Non-Expert Users:
Exclusion Criteria
1 CHP with ultrasound
2 Philips employees. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There is no formal endpoint .The study seeks to assess the Philips Obstretric Application Suite workflow, image quality, offline performance and gather user feedback as well as de-identified ultrasound exams data from 10 study subjects, for further algorithm development |
1 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
29/12/2025 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
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 study being conducted to assess Philips Obstetric Application Suite workflow, image quality, offline performance, and to gather user feedback. Pregnant subjects (at least 10) scheduled for their standard-of-care ultrasound exam at the site, will be requested to participate and enrolled. They will be scanned using both released/cleared Philips Lumify Ultrasound System and also with unreleased/investigational device. Scanning will be performed by certified healthcare professionals and study images/data will not be used for diagnosis. Data collected will provide information to support activities related to ultrasound product and algorithm development, and user preference activities, and marketing activities |