Imaging the Uterine Cervix - UltraSightHD™

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01090635

Enrollment

Registered

2010-03-22

Start date

2010-03-31

Completion date

2011-02-28

Last updated

2011-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine Cervical Neoplasms

Keywords

Cervical Intraepithelial Neoplasia

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Countries

United States

Outcome results