Investigation of the Uterine Cervix Using CervicalMD

Colposcopy Clinical Trial

Official title:

Investigational Study: Imaging the Uterine Cervix Using C30 Investigational Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00839475
• Other study ID #: 2008-1
• Status: Completed
• Phase: N/A
• First received: February 5, 2009
• Last updated: March 22, 2010
• Start date: June 2008
• Est. completion date: July 2009

Study information

• Verified date: March 2010
• Source: STI-Medical Systems
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationPeru: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: July 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Colposcopy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
STI-Medical Systems