Imaging the Uterine Cervix - UltraSightHD™

NCT ID: NCT01090635

Last Updated: 2011-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-02-28

Brief Summary

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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

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Conditions

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Uterine Cervical Neoplasms

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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STI-Medical Systems

INDUSTRY

Sponsor Role lead

Responsible Party

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STI- Medical Systems

Principal Investigators

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Nathan Fujita, M.D.

Role: PRINCIPAL_INVESTIGATOR

Locations

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Dr. Nathan Fujita

Honolulu, Hawaii, United States

Site Status

Countries

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United States

Other Identifiers

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2010-1

Identifier Type: -

Identifier Source: org_study_id

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