Philips Ultrasound Study Protocol – Reliance Diagnostic

This study is being conducted to assess or demonstrate both investigational and cleared ultrasound systems in human subjects. All scanning under this protocol is non-diagnostic and will be conducted using the ALARA principle to ensure the safety of the subjects. The objective of this study is to support ultrasound scanning activities in human subjects that assesses modifications to product design and development, and user preference evaluations. Data may be collected to validate user needs for final product designs. There are no formal endpoints, as the study is not being used to test for safety and efficacy. The study is intended to gather customer feedback on the ultrasound system to guide product development. This is a prospective, non-significant risk, non-randomized, single/multiple visit clinical study of subjects who provide written consent. Subjects are scanned using an investigational or cleared ultrasound system. After scanning is complete, their study obligations are over. No follow up is conducted. Up to 200 subjects per year for 2 years. As ultrasound imaging is based on non-ionizing radiation, it is generally considered safe when used by appropriately trained health care providers. The feedback obtained during the study will be used to guide product optimization and development. No statistical analysis will be conducted, as the study evaluates user preference.

In some subjects, the use of an ultrasound contrast agent (UCA) may be required for the ultrasound scan performed as part of routine care. In these subjects, the contrast agent may also be used for the study required ultrasound scan. Adverse events and adverse reactions related to the UCA are not considered study related adverse events. If a UCA is used it should be used in compliance with the approved indications and labeling, and the total amount of contrast administered to a subject shall be limited per the labelling of the UCA and at the discretion of the Investigator.