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

Resource links provided by NLM:


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
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 April 17, 2014