- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00266084
Clinical Trial for the Use of a Novel Cell Collector Device to Retrieve Cells From the Uterine Cervix
May 10, 2016 updated by: University Hospitals Cleveland Medical Center
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
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
Study Overview
Status
Completed
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
Study Type
Observational
Enrollment
85
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: George I Gorodeski, MD PhD, University Hospitals of Cleveland, Case Western Reserve University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 1999
Study Completion
November 1, 2001
Study Registration Dates
First Submitted
December 14, 2005
First Submitted That Met QC Criteria
December 14, 2005
First Posted (Estimate)
December 15, 2005
Study Record Updates
Last Update Posted (Estimate)
May 11, 2016
Last Update Submitted That Met QC Criteria
May 10, 2016
Last Verified
November 1, 2001
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Diseases
- Precancerous Conditions
- Carcinoma in Situ
- Neoplasms
- Uterine Cervical Neoplasms
- Cervical Intraepithelial Neoplasia
- Uterine Cervical Dysplasia
Other Study ID Numbers
- 02-00-16
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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