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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Region Skane
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- prostate biopsy length (measured by pathologist)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
Patient and pathologist are unaware of which needle/device is used. TRUSbx are taken from behind the back of the patient enabling masking from the patient.
Eligibility Criteria
- Ages
- 40 Years to 90 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Eligible for prostate biopsy
- •Signed informed written consent
Exclusion Criteria
- •None (other than general contra indications for prostate biopsy or patient not willing to participate)
Outcomes
Primary Outcomes
prostate biopsy length (measured by pathologist)
Time Frame: within 21 days post biopsy
Length of biopsy specimen in millimeters
Secondary Outcomes
- prostate biopsy length (measured in biopsy needle chamber)(within 21 days post biopsy)
- prostate biopsy length (measured in after removal from biopsy chamber)(within 21 days post biopsy)
- prostate biopsy fragmentation(within 21 days post biopsy)
- General appearance of biopsy assessed by pathologist (biopsy quality)(within 21 days post biopsy)