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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00266084
First Posted: December 15, 2005
Last Update Posted: May 11, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospitals Cleveland Medical Center
  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 1 Phase 2

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:


Further study details as provided by University Hospitals Cleveland Medical Center:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00266084


Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Investigators
Principal Investigator: George I Gorodeski, MD PhD University Hospitals of Cleveland, Case Western Reserve University
  More Information

ClinicalTrials.gov Identifier: NCT00266084     History of Changes
Other Study ID Numbers: 02-00-16
First Submitted: December 14, 2005
First Posted: December 15, 2005
Last Update Posted: May 11, 2016
Last Verified: November 2001

Keywords provided by University Hospitals Cleveland Medical Center:
Cervix
Uterus
Dysplasia
Cancer
Collector

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Neoplasms
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Uterine Cervical Dysplasia
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Precancerous Conditions