Clinical Trial for the Use of a Novel Cell Collector Device to Retrieve Cells From the Uterine Cervix
Primary Purpose
Uterine Cervical Dysplasia, Uterine Cervical Intraepithelial Neoplasia, Uterine Cervical Neoplasia
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Uterine Cervical Dysplasia focused on measuring Cervix, Uterus, Dysplasia, Cancer, Collector
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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00266084
First Posted
December 14, 2005
Last Updated
May 10, 2016
Sponsor
University Hospitals Cleveland Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00266084
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
Study Type
Observational
2. Study Status
Record Verification Date
November 2001
Overall Recruitment Status
Completed
Study Start Date
August 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2001 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospitals Cleveland Medical Center
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Cervical Dysplasia, Uterine Cervical Intraepithelial Neoplasia, Uterine Cervical Neoplasia, Uterine Cervical Cancer
Keywords
Cervix, Uterus, Dysplasia, Cancer, Collector
7. Study Design
Enrollment
85 (false)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George I Gorodeski, MD PhD
Organizational Affiliation
University Hospitals of Cleveland, Case Western Reserve University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial for the Use of a Novel Cell Collector Device to Retrieve Cells From the Uterine Cervix
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