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Physician's Comfort Level and Satisfaction Study With The e2TM Collector Compared to the Spatula/CytoBrush Technique

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ClinicalTrials.gov Identifier: NCT00496314
Recruitment Status : Terminated (Terminated for lack of resources to complete.)
First Posted : July 4, 2007
Last Update Posted : June 17, 2008
Sponsor:
Collaborator:
University Hospitals Cleveland Medical Center
Information provided by:
CytoCore, Inc.

Brief Summary:
A study which assesses the physician's comfort level and satisfaction when using the e2TM Collector compared to the Spatula/SytoBrush technique.

Condition or disease Intervention/treatment
Cervical Cell Collection Device: e2TM Cervical Cell Collector

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical Study Assessing Physician's Comfort Level and Satisfaction When Using The e2TM Cervical Cell Collector Compared to the Standard Spatula/CytoBrush Technique
Study Start Date : May 2007
Actual Study Completion Date : January 2008



Primary Outcome Measures :
  1. Physician comfort level and satisfaction when using the e2TM Collector compared to the standard spatula/cytobrush. [ Time Frame: Each physician will be surveyed after first and last use of the e2TM collector as well as three more times spaced at near regular intervals in between. ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Every Physician who will participate in the two CytoCore prospective studies assessing the safety and efficacy of the e2TM Collector
  • Each physician will have used the Collector 15 - 25 times
  • Each physician will have signed the Consent form prior to using the Collector for the first time.

Exclusion Criteria:

  • None (commensurate with the above inclusion conditions.)

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): NCT00496314


Locations
United States, Ohio
University Hospital CASE Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
CytoCore, Inc.
University Hospitals Cleveland Medical Center
Investigators
Principal Investigator: Jay Pinkerton, MD University Hospitals Cleveland Medical Center

Publications:

ClinicalTrials.gov Identifier: NCT00496314     History of Changes
Other Study ID Numbers: 12-20-06
First Posted: July 4, 2007    Key Record Dates
Last Update Posted: June 17, 2008
Last Verified: June 2008