Imaging the Uterine Cervix - UltraSightHD™

Completed

• Conditions: Uterine Cervical Neoplasms

• Registration Number: NCT01090635
• Lead Sponsor: STI-Medical Systems

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-18
• Study First Submitted QC: 2010-03-19
• Study First Posted: 2010-03-22
• Status Verified: 2011-02
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Last Update Submitted: 2011-02-03
• Last Update Posted: 2011-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 12

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Dr. Nathan Fujita; 🇺🇸 Honolulu, Hawaii, United States