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NCT00266084 Clinical Trial

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

Uterine Cervical Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00266084
Other study ID # 02-00-16
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received December 14, 2005
Last updated May 10, 2016
Start date August 1999
Est. completion date November 2001

Study information
Verified date November 2001
Source University Hospital Case Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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

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

Recruitment information / eligibility
Status Completed
Enrollment 85
Est. completion date November 2001
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 14 Years and older
Eligibility 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

N/A

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Case Medical Center
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