Imaging the Uterine Cervix - UltraSightHD™

Uterine Cervical Neoplasms Clinical Trial

Official title:

Imaging the Uterine Cervix - UltraSightHD™

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01090635
• Other study ID #: 2010-1
• Status: Completed
• Phase: N/A
• First received: March 18, 2010
• Last updated: February 3, 2011
• Start date: March 2010
• Est. completion date: February 2011

Study information

• Verified date: February 2011
• Source: STI-Medical Systems
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Uterine Cervical Neoplasms

Locations

Country	Name	City	State
United States	Dr. Nathan Fujita	Honolulu	Hawaii

Sponsors (1)

Lead Sponsor	Collaborator
STI-Medical Systems

Country where clinical trial is conducted

United States,