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

Completed

• Conditions: Uterine Cervical Dysplasia; Uterine Cervical Neoplasia; Uterine Cervical Cancer; Uterine Cervical Intraepithelial Neoplasia

• Registration Number: NCT00266084
• Lead Sponsor: University Hospitals Cleveland Medical Center

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

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 Timeline

• Study Start: 1999-08
• Status Verified: 2001-11
• Study Completion: 2001-11
• Study First Submitted: 2005-12-14
• Study First Submitted QC: 2005-12-14
• Study First Posted: 2005-12-15
• Last Update Submitted: 2016-05-10
• Last Update Posted: 2016-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 85

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

Exclusion Criteria

Patients who have had a hysterectomy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified