Clinical Trial for the Use of a Novel Cell Collector Device to Retrieve Cells From the Uterine Cervix
This study has been completed.
Sponsor:
University Hospitals of Cleveland
Information provided by:
University Hospitals of Cleveland
ClinicalTrials.gov Identifier:
NCT00266084
First received: December 14, 2005
Last updated: NA
Last verified: November 2001
History: No changes posted
| Tracking Information | |||||
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| First Received Date ICMJE | December 14, 2005 | ||||
| Last Updated Date | December 14, 2005 | ||||
| Start Date ICMJE | August 1999 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Clinical Trial for the Use of a Novel Cell Collector Device to Retrieve Cells From the Uterine Cervix | ||||
| Official Title ICMJE | 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 | ||||
| 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 |
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| 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 |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Not Provided | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Not Provided | ||||
| Study Population | Not Provided | ||||
| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 85 | ||||
| Completion Date | November 2001 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | 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 |
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| Gender | Female | ||||
| Ages | 14 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00266084 | ||||
| Other Study ID Numbers ICMJE | 02-00-16 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | University Hospitals of Cleveland | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University Hospitals of Cleveland | ||||
| Verification Date | November 2001 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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