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

NCT ID: NCT00266084

Last Updated: 2016-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

85 participants

Study Classification

OBSERVATIONAL

Study Start Date

1999-08-31

Study Completion Date

2001-11-30

Brief Summary

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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

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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

Conditions

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Uterine Cervical Dysplasia Uterine Cervical Intraepithelial Neoplasia Uterine Cervical Neoplasia Uterine Cervical Cancer

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospitals Cleveland Medical Center

OTHER

Sponsor Role lead

Principal Investigators

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George I Gorodeski, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals of Cleveland, Case Western Reserve University

Other Identifiers

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02-00-16

Identifier Type: -

Identifier Source: org_study_id

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