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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02375035
Other study ID # AO93224
Secondary ID
Status Recruiting
Phase N/A
First received February 19, 2015
Last updated February 24, 2015
Start date January 2015
Est. completion date September 2019

Study information

Verified date February 2015
Source Cambridge University Hospitals NHS Foundation Trust
Contact Vincent Gnanapragasam
Phone +44 1223 348363
Email vjg29@cam.ac.uk
Is FDA regulated No
Health authority United Kingdom: National Health Service
Study type Observational

Clinical Trial Summary

To evaluate the use of the CAMbridge PROstate Biopsy devicE (CAMPROBE) as a method of undertaking prostate biopsy as part of their clinical management.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date September 2019
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- Fit and well enough to undergo a repeat prostate biopsy

- Men who have previously had a transrectal ultrasound biopsy of the prostate and due to have a repeat biopsy as part of normal care

- Men on active surveillance

- Men on PSA monitoring

Exclusion Criteria:

- Contraindication for a repeat prostate biopsy

- Contraindication for a transperineal prostate biopsies

- Previous perineal or anal surgery

- MRI suggesting anterior lesion or extra capsular disease

- MRI suggesting lesion that needs fusion image targeting

- Unable to lie down and with legs in a stirrup for at least 45 minutes

Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United Kingdom Cambridge University Hospitals NHS Foundation Trust Cambridge

Sponsors (1)

Lead Sponsor Collaborator
Cambridge University Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain score assessment of CAMPROBE biopsy procedure Measured using a 10 point visual pain score tool and a point based structured questionnaire 3 weeks No
Primary Patient reported adverse events related to CAMPROBE biopsy Point based structured questionnaire assessment of adverse events after biopsy 3 weeks No
Primary Patient perception and acceptance of CAMPROBE biopsy Point based structured questionnaire including willingness to recommend to a friend 3 weeks No
Secondary Deterioration in urinary function after CAMPROBE biopsy Measurement of urinary function after the procedure using a structured questionnaire 3 weeks No
Secondary Deterioration in sexual function after CAMPROBE biopsy Measurement of urinary function after the procedure using a structured questionnaire 3 weeks No
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