Brief Title
Clinical Trial for the Use of a Novel Cell Collector Device to Retrieve Cells From the Uterine Cervix
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
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 Type
Observational
Condition
Uterine Cervical Dysplasia
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
85
Start Date
August 1999
Completion Date
November 2001
Eligibility 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
Gender
Female
Ages
14 Years - N/A
Accepts Healthy Volunteers
No
Contacts
George I Gorodeski, MD PhD, ,
Administrative Informations
NCT ID
NCT00266084
Organization ID
02-00-16
Study Sponsor
University Hospitals Cleveland Medical Center
Study Sponsor
George I Gorodeski, MD PhD, Principal Investigator, University Hospitals of Cleveland, Case Western Reserve University
Verification Date
November 2001