Investigation of the Uterine Cervix Using CervicalMD

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: NCT00839475
Recruitment Status : Completed
First Posted : February 9, 2009
Last Update Posted : March 24, 2010
Information provided by:
STI-Medical Systems

Brief Summary:
The purpose of this study is to demonstrate the CervicalMD device's ability to collect digital imagery suitable for a colposcopy examination.

Condition or disease

Study Type : Observational
Actual Enrollment : 26 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Investigational Study: Imaging the Uterine Cervix Using C30 Investigational Device
Study Start Date : June 2008
Primary Completion Date : November 2008
Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Biospecimen Retention:   Samples Without DNA
LEEP specimens

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women identified with an abnormal Pap smear

Inclusion Criteria:

  • Female
  • Negative Pregnancy test
  • Abnormal Pap smear
  • 18 years and older
  • Presence of a cervix

Exclusion Criteria:

  • Pregnant
  • Absence of a cervix
  • Less than 18 years old
  • Male

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): NCT00839475

Sponsors and Collaborators
STI-Medical Systems
Principal Investigator: Daron G Ferris, MD Augusta University

Responsible Party: Jody Oyama, Clinical Director, STI-Medical Systems, Identifier: NCT00839475     History of Changes
Other Study ID Numbers: 2008-1
First Posted: February 9, 2009    Key Record Dates
Last Update Posted: March 24, 2010
Last Verified: March 2010

Keywords provided by STI-Medical Systems:
Cervical intraepithelial neoplasia
cervical cancer
cervical precancer