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NCT04843566Recruiting

Evaluation of Transperineal Biopsy Under Local Anesthesia

Evaluation of Transperineal Biopsy Under Local Anesthesia, a Novel Approach to Decrease Post-Biopsy Infections and Improve Cancer Detection
Weill Medical College of Cornell UniversityClinicalTrials.govprocedure
Study focus
Disease/Condition
Infection
Drug/Device/Intervention
Transperineal MRI-guided prostate biopsy
Study type
Interventional
Intervention type
procedure
Sponsor & location
Primary sponsor
Weill Medical College of Cornell University
Location
Chicago,Baltimore,New York,New York, United States of America
Timeline & enrollment
Phase
N/A
Start date
Mar 22, 2021
End date
Jun 01, 2025
Enrollment
400 participants
Primary outcome

Change in infection adverse events, as measured on Transrectal Ultrasound Guided prostate Biopsy Questionnaire (TRUS-BxQ)

Summary

Approximately one million transrectal prostate biopsies are performed annually in the U.S.,
 and the risk of post- biopsy infection is increasing due to greater antibiotic resistance of
 rectal flora. Preliminary data demonstrates that a transperineal MRI-targeted biopsy approach
 under local anesthesia compared to the standard practice transrectal MRI-targeted prostate
 biopsy has a much lower risk of infection, comparable pain/discomfort and may improve
 detection of prostate cancer.
 
 This randomized controlled trial will be the first prospective study to evaluate in-office
 transperineal MRI targeted prostate biopsy.
 
 The investigators hypothesize that a transperineal MRI-targeted biopsy approach under local
 anesthesia compared to the standard practice transrectal MRI-targeted prostate biopsy has a
 much lower risk of infection, comparable pain/discomfort and may improve detection of
 prostate cancer.

ICD-10 classifications
Bacterial infection, unspecifiedBacterial, viral and other infectious agentsInfection following immunizationOther infectious diseasesViral infection, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT04843566
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT04843566 through Pure Global AI's free database. This phase not specified trial is sponsored by Weill Medical College of Cornell University and is currently Recruiting. The study focuses on Infection. Target enrollment is 400 participants.

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