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Clinical Trial Summary

Patient blinded randomized prospective trial evaluating prostate biopsy quality of a novel biopsy needle.


Clinical Trial Description

Prostate biopsy is the golden standard for diagnose of prostate cancer. Transrectal prostate biopsy (TRUSbx) is the most widely used technique. Due to the transrectal path the biopsy needle will bring bacteria from the colon into tissue. The patent should always receive prophylactic antibiotics to reduce the risk of clinical infection. Infections related to transrectal prostate biopsy (TRUSbx) are increasing in parallel with rising antibiotic resistance. The investigators have in an ex-vivo setting previously shown a drastic reduction in bacterial transfer across the colon wall using a novel biopsy needle designed to minimize bacterial transfer. Biopsy of prostatectomy specimen using the novel needle has shown biopsy quality equal to the tru cut biopsy needle used today. This is the first human pilot aiming to evaluate if biopsy quality of the novel needle is equal to the reference tru cut biopsy needle in prostate biopsy. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04091230
Study type Interventional
Source Region Skane
Contact
Status Completed
Phase N/A
Start date September 10, 2019
Completion date November 1, 2019

See also
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Recruiting NCT04880681 - Evaluation of Length and Quality of Prostate Biopsies Taken by a New Biopsy Needle N/A
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