Clinical trial NCT00496314: Physician's Comfort Level and Satisfaction Study With The e2TM Collector Compared to the Spatula/CytoBrush Technique
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 type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cervical Cell Collection
Lead sponsor: CytoCore, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University Hospitals Cleveland Medical Center
First posted: 2007-07-04
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE

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


Eligibility 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.)

Primary outcomes:
measure: Physician comfort level and satisfaction when using the e2TM Collector compared to the standard spatula/cytobrush.
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospital CASE Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Jay Pinkerton, MD
role: PRINCIPAL_INVESTIGATOR
References:
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