Investigation of the Uterine Cervix Using CervicalMD

March 22, 2010 updated by: STI-Medical Systems

Investigational Study: Imaging the Uterine Cervix Using C30 Investigational Device

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

26

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women identified with an abnormal Pap smear

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

STI-Medical Systems

Investigators

  • Principal Investigator: Daron G Ferris, MD, Augusta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

February 5, 2009

First Submitted That Met QC Criteria

February 5, 2009

First Posted (Estimate)

February 9, 2009

Study Record Updates

Last Update Posted (Estimate)

March 24, 2010

Last Update Submitted That Met QC Criteria

March 22, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2008-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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