Clinical Trial for the Use of a Novel Cell Collector Device to Retrieve Cells From the Uterine Cervix

Sponsor

University Hospitals Cleveland Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00266084

Collaborator

(none)

Enrollment

Duration (Months)

Study Details

Study Description

Brief Summary

This study tested the safety and performance of a new cell collector device and compared the results to those obtained with the current existing device that are being used routinely

Condition or Disease	Intervention/Treatment	Phase
Uterine Cervical Dysplasia Uterine Cervical Intraepithelial Neoplasia Uterine Cervical Neoplasia Uterine Cervical Cancer

Detailed Description

This study tested the feasibility, safety and efficacy of the new e2TM Collector, and compared its performance with the standard method for obtaining cervical cells for Pap test of endocervical cytobrush and Ayer's Spatula

Study Design

Study Type:

Observational

Official Title:

Double-Blinded Multicenter Clinical Study Assessing the Equivalence of the InPath Cervical Cell Collector to the Standard Endocervical Brush and Spatula in Patients Seeking Primary Pap Screening or Follow-up Screening

Study Start Date :

Aug 1, 1999

Study Completion Date :

Nov 1, 2001

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Women ages >14 being followed for a previous abnormal Pap All patients will have signed an Informed Consent form prior to being enrolled in this study