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Clinical Trials/NCT01090635
NCT01090635CompletedNot Applicable

Imaging the Uterine Cervix - UltraSightHD™

STI-Medical Systems1 site in 1 country12 target enrollmentStarted: March 2010Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
12
Locations
1
Study OverviewStudy DesignEligibility CriteriaInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

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

Investigators

Sponsor
STI-Medical Systems
Sponsor Class
Industry

Study Sites (1)

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