NCT04091230

New Biopsy Needle - Evaluation of Prostate Biopsy Quality

Prospective Patient Blinded Randomized Trial Comparing Biopsy Specimen Quality in a Novel Biopsy Needle and Actuator Compared to Todays Standard Tru Cut Needle and Actuator.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Region Skane · Academic / Other
• Sex: Male
• Age: 40 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Prostate Cancer (Diagnosis)

Interventions

Type	Name	Description
DEVICE	TRUSbx	Trans Rectal UltraSound guided Prostate Biopsy

Timeline

• Start date: 2019-09-10
• Primary completion: 2019-10-30
• Completion: 2019-11-01
• First posted: 2019-09-16
• Last updated: 2021-02-10

Locations

1 site across 1 country: Sweden