Study Stopped
Terminated for lack of resources to complete.
Physician's Comfort Level and Satisfaction Study With The e2TM Collector Compared to the Spatula/CytoBrush Technique
Clinical Study Assessing Physician's Comfort Level and Satisfaction When Using The e2TM Cervical Cell Collector Compared to the Standard Spatula/CytoBrush Technique
1 other identifier
observational
30
1 country
1
Brief Summary
A study which assesses the physician's comfort level and satisfaction when using the e2TM Collector compared to the Spatula/SytoBrush technique.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2007
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 2, 2007
CompletedFirst Posted
Study publicly available on registry
July 4, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedJune 17, 2008
June 1, 2008
July 2, 2007
June 13, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
Physician comfort level and satisfaction when using the e2TM Collector compared to the standard spatula/cytobrush.
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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CytoCore, Inc.lead
- University Hospitals Cleveland Medical Centercollaborator
Study Sites (1)
University Hospital CASE Medical Center
Cleveland, Ohio, 44106, United States
Related Publications (15)
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. doi: 10.1056/NEJMoa021641.
PMID: 12571259BACKGROUNDSankaranarayanan 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.
PMID: 11693978BACKGROUNDUmland 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. doi: 10.1097/00001888-199205000-00004. No abstract available.
PMID: 1575861BACKGROUNDHolowaty 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. doi: 10.1093/jnci/91.16.1420a. No abstract available.
PMID: 10451450BACKGROUNDSolomon 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. doi: 10.1001/jama.287.16.2114.
PMID: 11966386BACKGROUNDNanda 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. doi: 10.7326/0003-4819-132-10-200005160-00009.
PMID: 10819705BACKGROUNDFahey MT, Irwig L, Macaskill P. Meta-analysis of Pap test accuracy. Am J Epidemiol. 1995 Apr 1;141(7):680-9. doi: 10.1093/oxfordjournals.aje.a117485.
PMID: 7702044BACKGROUNDClavel 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. doi: 10.1054/bjoc.2001.1845.
PMID: 11401314BACKGROUNDWillis 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. doi: 10.3310/hta9130.
PMID: 15774236BACKGROUNDBuntinx 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. doi: 10.1136/bmj.313.7068.1285.
PMID: 8942687BACKGROUNDMartin-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. doi: 10.1016/s0140-6736(99)02353-3.
PMID: 10577637BACKGROUNDMartin-Hirsch P, Jarvis G, Kitchener H, Lilford R. Collection devices for obtaining cervical cytology samples. Cochrane Database Syst Rev. 2000;2000(2):CD001036. doi: 10.1002/14651858.CD001036.
PMID: 10796736BACKGROUNDSelvaggi SM, Guidos BJ. Specimen adequacy and the ThinPrep Pap Test: the endocervical component. Diagn Cytopathol. 2000 Jul;23(1):23-6. doi: 10.1002/1097-0339(200007)23:13.0.CO;2-K.
PMID: 10907927BACKGROUNDMarchand L, Mundt M, Klein G, Agarwal SC. Optimal collection technique and devices for a quality pap smear. WMJ. 2005 Aug;104(6):51-5.
PMID: 16218317BACKGROUNDKoss LG. Evolution in cervical pathology and cytology: a historical perspective. Eur J Gynaecol Oncol. 2000;21(6):550-4. No abstract available.
PMID: 11214608BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Jay Pinkerton, MD
University Hospitals Cleveland Medical Center
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 2, 2007
First Posted
July 4, 2007
Study Start
May 1, 2007
Study Completion
January 1, 2008
Last Updated
June 17, 2008
Record last verified: 2008-06