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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.
Patient blinded randomized prospective trial evaluating prostate biopsy quality of a novel biopsy needle.
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.
Age
40 - 90 years
Sex
MALE
Healthy Volunteers
No
Helsingborg Hospital
Helsingborg, Skåne County, Sweden
Start Date
September 10, 2019
Primary Completion Date
October 30, 2019
Completion Date
November 1, 2019
Last Updated
February 10, 2021
20
ACTUAL participants
TRUSbx
DEVICE
Lead Sponsor
Region Skane
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT07271017