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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014