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

This study has been terminated.
(Terminated for lack of resources to complete.)
Sponsor:
Collaborator:
University Hospitals of Cleveland
Information provided by:
CytoCore, Inc.
ClinicalTrials.gov Identifier:
NCT00496314
First received: July 2, 2007
Last updated: June 13, 2008
Last verified: June 2008
  Purpose

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


Condition Intervention
Cervical Cell Collection
Device: e2TM Cervical Cell Collector

Study Type: Observational
Study Design: 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

Further study details as provided by CytoCore, Inc.:

Primary Outcome Measures:
  • 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. ]

Estimated Enrollment: 30
Study Start Date: May 2007
Study Completion Date: January 2008
  Eligibility

Genders Eligible for Study:   Both
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.)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00496314

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

Publications:

ClinicalTrials.gov Identifier: NCT00496314     History of Changes
Other Study ID Numbers: 12-20-06
Study First Received: July 2, 2007
Last Updated: June 13, 2008
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 15, 2014