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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
University Hospitals Cleveland Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Uterine Cervical Dysplasia focused on measuring Cervix, Uterus, Dysplasia, Cancer, Collector

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    December 14, 2005
    Last Updated
    May 10, 2016
    Sponsor
    University Hospitals Cleveland Medical Center
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    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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