Investigation of the Uterine Cervix Using CervicalMD

This study has been completed.
Sponsor:
Information provided by:
STI-Medical Systems
ClinicalTrials.gov Identifier:
NCT00839475
First received: February 5, 2009
Last updated: March 22, 2010
Last verified: March 2010
  Purpose

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


Condition
Colposcopy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Investigational Study: Imaging the Uterine Cervix Using C30 Investigational Device

Further study details as provided by STI-Medical Systems:

Biospecimen Retention:   Samples Without DNA

LEEP specimens


Enrollment: 26
Study Start Date: June 2008
Study Completion Date: July 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women identified with an abnormal Pap smear

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00839475

Sponsors and Collaborators
STI-Medical Systems
Investigators
Principal Investigator: Daron G Ferris, MD Georgia Regents University
  More Information

No publications provided

Responsible Party: Jody Oyama, Clinical Director, STI-Medical Systems,
ClinicalTrials.gov Identifier: NCT00839475     History of Changes
Other Study ID Numbers: 2008-1
Study First Received: February 5, 2009
Last Updated: March 22, 2010
Health Authority: United States: Food and Drug Administration
Peru: Ministry of Health

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

ClinicalTrials.gov processed this record on July 24, 2014