NCT00839475

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2008

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 9, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

March 24, 2010

Status Verified

March 1, 2010

Enrollment Period

5 months

First QC Date

February 5, 2009

Last Update Submit

March 22, 2010

Conditions

Colposcopy

Keywords

colposcopyCervical intraepithelial neoplasiacervical cancercervical precancer

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women identified with an abnormal Pap smear

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

LEEP specimens

MeSH Terms

Conditions

Uterine Cervical DysplasiaUterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by Site

Study Officials

  • Daron G Ferris, MD

    Augusta University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 5, 2009

First Posted

February 9, 2009

Study Start

June 1, 2008

Primary Completion

November 1, 2008

Study Completion

July 1, 2009

Last Updated

March 24, 2010

Record last verified: 2010-03