Imaging the Uterine Cervix - UltraSightHD™

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. Identifier: NCT01090635
Recruitment Status : Completed
First Posted : March 22, 2010
Last Update Posted : February 4, 2011
Information provided by:
STI-Medical Systems

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.

Condition or disease
Uterine Cervical Neoplasms

Study Type : Observational
Actual Enrollment : 12 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Imaging the Uterine Cervix - UltraSightHD™
Study Start Date : March 2010
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy non-pregnant females over 18 years old.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01090635

United States, Hawaii
Dr. Nathan Fujita
Honolulu, Hawaii, United States, 96813
Sponsors and Collaborators
STI-Medical Systems
Principal Investigator: Nathan Fujita, M.D.

Responsible Party: Rolf Wolters, Sr. VP., STI- Medical Systems Identifier: NCT01090635     History of Changes
Other Study ID Numbers: 2010-1
First Posted: March 22, 2010    Key Record Dates
Last Update Posted: February 4, 2011
Last Verified: February 2011

Keywords provided by STI-Medical Systems:
Cervical Intraepithelial Neoplasia

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female