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

Tracking Information

First Received Date ^ICMJE

December 14, 2005

Last Updated Date

December 14, 2005

Start Date ^ICMJE

August 1999

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Phase

Phase I, Phase II

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Condition ^ICMJE

Uterine Cervical Dysplasia
Uterine Cervical Intraepithelial Neoplasia
Uterine Cervical Neoplasia
Uterine Cervical Cancer

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2001

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

14 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00266084

Responsible Party

Study ID Numbers ^ICMJE

02-00-16

Study Sponsor ^ICMJE

University Hospitals of Cleveland

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

George I Gorodeski, MD PhD

University Hospitals of Cleveland, Case Western Reserve University

Information Provided By

University Hospitals of Cleveland

Verification Date

November 2001

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP