iMAMA Feasibility Study Protocol- India
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Philips India Limited
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- 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
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- Female
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
- •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.
Outcomes
Primary Outcomes
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
Time Frame: 1 day
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr Arul Dasan
Bangalore Medical College & Research Institute