High Resolution Digital Imaging of the Uterine Cervix

Colposcopy Clinical Trial

Official title:

Investigation to Correlate High Resolution Digital Images of the Uterine Cervix With Histopathology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00941512
• Other study ID #: 2005-1
• Status: Completed
• Phase: N/A
• First received: July 15, 2009
• Last updated: July 15, 2009
• Start date: April 2005
• Est. completion date: December 2005

Study information

• Verified date: July 2009
• Source: STI-Medical Systems
• Contact: n/a
• Is FDA regulated: No
• Health authority: Peru: Ministry of Health
• Study type: Observational

Clinical Trial Summary

This study was designed to gather digital pictures of the cervix and correlate it to its histopathology, and then use those relationships to teach a computer how to objectively find cervical dysplasia and cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Female

• Negative pregnancy test

• 18 years and older

• Presence of a cervix

Exclusion Criteria:

• Pregnant

• Absence of a cervix

• Less than 18 years old

• Male

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Colposcopy

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
STI-Medical Systems	Eisenhower Army Medical Center, Instituto National de Edfermedades Neoplasicas