Skip to content

A Clinical Investigation study to assess the performance of the investigational Philips Obstetric Application suite

iMAMA Feasibility Study Protocol- India - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/12/099233
Enrollment
10
Registered
2025-12-16
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O998- Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium

Interventions

Intervention1: 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

Sponsors

Philips India Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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 developmentTimepoint: 1 day

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactVijendra Singh Mandloi

PHILIPS INDIA LIMITED

madhumita.gupta@philips.com9900568016

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026