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

History of Changes

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:

Munoz N, Bosch FX, de Sanjose S, Herrero R, Castellsague X, Shah KV, Snijders PJ, Meijer CJ; International Agency for Research on Cancer Multicenter Cervical Cancer Study Group. Epidemiologic classification of human papillomavirus types associated with cervical cancer. N Engl J Med. 2003 Feb 6;348(6):518-27.

Sankaranarayanan R, Budukh AM, Rajkumar R. Effective screening programmes for cervical cancer in low- and middle-income developing countries. Bull World Health Organ. 2001;79(10):954-62. Epub 2001 Nov 1. Review.

Umland B, Waterman R, Wiese W, Duban S, Mennin S, Kaufman A. Learning from a rural physician program in China. Acad Med. 1992 May;67(5):307-9. No abstract available.

Holowaty P, Miller AB, Rohan T, To T. RESPONSE: re: natural history of dysplasia of the uterine cervix J Natl Cancer Inst. 1999 Aug 18;91(16):1420A-1421. No abstract available.

Solomon D, Davey D, Kurman R, Moriarty A, O'Connor D, Prey M, Raab S, Sherman M, Wilbur D, Wright T Jr, Young N; Forum Group Members; Bethesda 2001 Workshop. The 2001 Bethesda System: terminology for reporting results of cervical cytology. JAMA. 2002 Apr 24;287(16):2114-9. Review.

Nanda K, McCrory DC, Myers ER, Bastian LA, Hasselblad V, Hickey JD, Matchar DB. Accuracy of the Papanicolaou test in screening for and follow-up of cervical cytologic abnormalities: a systematic review. Ann Intern Med. 2000 May 16;132(10):810-9. Review.

Fahey MT, Irwig L, Macaskill P. Meta-analysis of Pap test accuracy. Am J Epidemiol. 1995 Apr 1;141(7):680-9.

Clavel C, Masure M, Bory JP, Putaud I, Mangeonjean C, Lorenzato M, Nazeyrollas P, Gabriel R, Quereux C, Birembaut P. Human papillomavirus testing in primary screening for the detection of high-grade cervical lesions: a study of 7932 women. Br J Cancer. 2001 Jun 15;84(12):1616-23.

Willis BH, Barton P, Pearmain P, Bryan S, Hyde C. Cervical screening programmes: can automation help? Evidence from systematic reviews, an economic analysis and a simulation modelling exercise applied to the UK. Health Technol Assess. 2005 Mar;9(13):1-207, iii. Review.

Buntinx F, Brouwers M. Relation between sampling device and detection of abnormality in cervical smears: a meta-analysis of randomised and quasi-randomised studies. BMJ. 1996 Nov 23;313(7068):1285-90.

Martin-Hirsch P, Lilford R, Jarvis G, Kitchener HC. Efficacy of cervical-smear collection devices: a systematic review and meta-analysis. Lancet. 1999 Nov 20;354(9192):1763-70. Erratum in: Lancet 2000 Jan 29;355(9201):414.

Martin-Hirsch P, Jarvis G, Kitchener H, Lilford R. Collection devices for obtaining cervical cytology samples. Cochrane Database Syst Rev. 2000;(2):CD001036. Review. Update in: Cochrane Database Syst Rev. 2000;(3):CD001036.

Selvaggi SM, Guidos BJ. Specimen adequacy and the ThinPrep Pap Test: the endocervical component. Diagn Cytopathol. 2000 Jul;23(1):23-6.

Marchand L, Mundt M, Klein G, Agarwal SC. Optimal collection technique and devices for a quality pap smear. WMJ. 2005 Aug;104(6):51-5.

Koss LG. Evolution in cervical pathology and cytology: a historical perspective. Eur J Gynaecol Oncol. 2000;21(6):550-4. No abstract available.

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 May 22, 2013

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