Imaging the Uterine Cervix - UltraSightHD™

STI-Medical Systems

Status: Completed

Conditions: Uterine Cervical Neoplasms

Study type: Observational

Funder types: Industry

Identifiers

NCT01090635

2010-1

Details and patient eligibility

About

The purpose of this study is to investigate the performance ability of the UltraSightHD™. The instrument will be assessed on characteristics such as focus quality, ability to image the entire cervix, and illumination. The information gathered from this study will provide data that will be used to determine which settings provide the best imaging outcome for the cervix for a simple screening instrument. Further, this information will serve as the foundation in the development of more advanced follow-on imaging devices.

The primary objectives of this study are to:

• Determine if the light source provides sufficient illumination of the cervix.
• Assess focus and overall image quality.
• Assess the functionality and ergonomics of the instrument's design.

Enrollment: 12 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy Female
• 18 years old or older
• Not pregnant
• Ability to give consent

Exclusion criteria

• Male
• Less than 18 years old
• Pregnant or suspected pregnancy