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Development and validation of a portable, screenless ultrasound device (SecureUS) for pregnancy and fetal monitoring in primary healthcare setting.

SecureUS: Development and Field Validation of the Advanced Secure Ultrasound Imaging System in Primary Healthcare settings - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/06/088209
Enrollment
760
Registered
2025-06-04
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Health Condition 1: Z349- Encounter for supervision of normal pregnancy, unspecified

Interventions

Intervention1: NIL: NIL Intervention2: Nil: Nil Control Intervention1: NIL: NIL

Sponsors

Indian Council of Medical Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: For stakeholder study, men and women in the health system and community of age 18 years and above. For device field validation, pregnant women attending regular, Ultrasound scanning process during ante natal care at the healthcare centers.

Exclusion criteria

Exclusion criteria: Not applicable for stakeholder study as volunteers will be recruited purposively. For device field validation pregnant women who require emergency medical care or have a metal implant in thoracic or abdominal region

Design outcomes

Primary

MeasureTime frame
The agreement between fetal biometry and well-being assessments obtained from SecureUS and a gold standard ultrasound machine, evaluated using a six-step radiological assessment based on ISUOG recommendations.Timepoint: At baseline

Secondary

MeasureTime frame
1. Perceptions regarding antenatal care ultrasound among healthcare system personnel & community (Stakeholder study) 2. Completeness & quality of the antenatal care ultrasound data captured by SecureUS (Device Field Validation). 3. Effectiveness of technician training in ensuring consistent & standardized SecureUS scanning procedures.Timepoint: 1. Stakeholder interviews: at baseline 2. Device Field Validation: at baseline 3. Technician training evaluation: at baseline & one day after training.

Countries

India

Contacts

Public ContactDr Dhinagaran Devadass

Indian Institute of Science Bengaluru

marora@iisc.ac.in9980836174

Outcome results

None listed

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