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

This study has been completed.

First Received: December 14, 2005 No Changes Posted

Sponsored by:	University Hospitals of Cleveland
Information provided by:	University Hospitals of Cleveland
ClinicalTrials.gov Identifier:	NCT00266084

Purpose

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	Phase
Uterine Cervical Dysplasia Uterine Cervical Intraepithelial Neoplasia Uterine Cervical Neoplasia Uterine Cervical Cancer	Phase I Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by University Hospitals of Cleveland:

Estimated Enrollment:	85
Study Start Date:	August 1999
Estimated Study Completion Date:	November 2001

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

Eligibility

Ages Eligible for Study:	14 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00266084

Sponsors and Collaborators

University Hospitals of Cleveland

Investigators

Principal Investigator:

George I Gorodeski, MD PhD

University Hospitals of Cleveland, Case Western Reserve University

More Information

No publications provided

Study ID Numbers:	02-00-16
Study First Received:	December 14, 2005
Last Updated:	December 14, 2005
ClinicalTrials.gov Identifier:	NCT00266084 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University Hospitals of Cleveland:

Cervix
Uterus
Dysplasia
Cancer
Collector

Study placed in the following topic categories:

Precancerous Conditions
Genital Neoplasms, Female
Uterine Diseases
Urogenital Neoplasms
Cervical Intraepithelial Neoplasia
Carcinoma
Uterine Cervical Neoplasms

Genital Diseases, Female
Uterine Cervical Diseases
Carcinoma in Situ
Uterine Neoplasms
Uterine Cervical Dysplasia
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Precancerous Conditions
Genital Neoplasms, Female
Uterine Diseases
Urogenital Neoplasms
Cervical Intraepithelial Neoplasia
Carcinoma
Uterine Cervical Neoplasms

Genital Diseases, Female
Neoplasms
Uterine Cervical Diseases
Neoplasms by Site
Carcinoma in Situ
Uterine Neoplasms
Uterine Cervical Dysplasia
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on July 06, 2009