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Imaging the Uterine Cervix - UltraSightHD™

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01090635
First Posted: March 22, 2010
Last Update Posted: February 4, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
STI-Medical Systems
March 18, 2010
March 22, 2010
February 4, 2011
March 2010
February 2011   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01090635 on ClinicalTrials.gov Archive Site
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Imaging the Uterine Cervix - UltraSightHD™
Imaging the Uterine Cervix - UltraSightHD™

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.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample
Healthy non-pregnant females over 18 years old.
Uterine Cervical Neoplasms
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
February 2011
February 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01090635
2010-1
No
Not Provided
Not Provided
Rolf Wolters, Sr. VP., STI- Medical Systems
STI-Medical Systems
Not Provided
Principal Investigator: Nathan Fujita, M.D.
STI-Medical Systems
February 2011