Developing a Safer and More Accurate Device for Biopsies of Suspected Prostate Cancer (CAMPROBE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02375035|
Recruitment Status : Unknown
Verified February 2015 by Vincent Gnanapragasam, Cambridge University Hospitals NHS Foundation Trust.
Recruitment status was: Recruiting
First Posted : March 2, 2015
Last Update Posted : March 2, 2015
|Condition or disease||Intervention/treatment|
|Prostate Cancer Prostate Biopsy||Device: CAMPROBE|
To assess patient's experience and complications of the CAMPROBE and compare the results with known published outcomes from standard transrectal biopsies .
To use data from the pilot study to determine the feasibility of a randomised trial comparing CAMPROBE with the current standard method of prostate biopsies.
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Developing a Safer and More Accurate Device for Biopsies of Suspected Prostate Cancer|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||September 2019|
- Device: CAMPROBE
To assess patient's experience and complications of the CAMPROBE biopsy needle and compare the results with known published outcomes from standard transrectal biopsies
- Pain score assessment of CAMPROBE biopsy procedure [ Time Frame: 3 weeks ]Measured using a 10 point visual pain score tool and a point based structured questionnaire
- Patient reported adverse events related to CAMPROBE biopsy [ Time Frame: 3 weeks ]Point based structured questionnaire assessment of adverse events after biopsy
- Patient perception and acceptance of CAMPROBE biopsy [ Time Frame: 3 weeks ]Point based structured questionnaire including willingness to recommend to a friend
- Deterioration in urinary function after CAMPROBE biopsy [ Time Frame: 3 weeks ]Measurement of urinary function after the procedure using a structured questionnaire
- Deterioration in sexual function after CAMPROBE biopsy [ Time Frame: 3 weeks ]Measurement of urinary function after the procedure using a structured questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02375035
|Contact: Vincent Gnanapragasam||+44 1223 firstname.lastname@example.org|
|Contact: Anne George||+44 1223 email@example.com|
|Cambridge University Hospitals NHS Foundation Trust||Recruiting|
|Cambridge, United Kingdom, CB2 0QQ|
|Contact: Stephen Kelleher +44 1223 217418 firstname.lastname@example.org|
|Principal Investigator:||Vincent Gnanapragasam||University of Cambridge|