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Imaging the Uterine Cervix - UltraSightHD™

This study has been completed.
Sponsor:
Information provided by:
STI-Medical Systems
ClinicalTrials.gov Identifier:
NCT01090635
First received: March 18, 2010
Last updated: February 3, 2011
Last verified: February 2011
History of Changes
  Purpose

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
Uterine Cervical Neoplasms

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Imaging the Uterine Cervix - UltraSightHD™

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by STI-Medical Systems:

Enrollment: 12
Study Start Date: March 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy non-pregnant females over 18 years old.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01090635

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

No publications provided

Responsible Party: Rolf Wolters, Sr. VP., STI- Medical Systems
ClinicalTrials.gov Identifier: NCT01090635     History of Changes
Other Study ID Numbers: 2010-1
Study First Received: March 18, 2010
Last Updated: February 3, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by STI-Medical Systems:
Cervical Intraepithelial Neoplasia

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

ClinicalTrials.gov processed this record on May 19, 2013