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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04091230

Enrollment

Registered

2019-09-16

Start date

2019-09-10

Completion date

2019-11-01

Last updated

2021-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer (Diagnosis)

Keywords

biopsy quality

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.

Interventions

DEVICETRUSbx

Trans Rectal UltraSound guided Prostate Biopsy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

DOUBLE (Subject, 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.

Intervention model description

20 patients eligible for prostate biopsy are randomized into 2 arms (10+10 patients) using either the novel needle and actuator device or standard tru cut needle and actuator device used in the clinic today. On average 12 biopsies are taken from each patient. Biopsy quality is evaluated by the pathologist blinded to device used.

Eligibility

Sex/Gender

MALE

Age

40 Years to 90 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
prostate biopsy length (measured by pathologist)	within 21 days post biopsy	Length of biopsy specimen in millimeters

Secondary

Measure	Time frame	Description
General appearance of biopsy assessed by pathologist (biopsy quality)	within 21 days post biopsy	General quality of biopsy specimen on a scale from 0-3 (no biopsy, poor, good, excellent)
prostate biopsy length (measured in biopsy needle chamber)	within 21 days post biopsy	Length of biopsy specimen in millimeters
prostate biopsy length (measured in after removal from biopsy chamber)	within 21 days post biopsy	Length of biopsy specimen in millimeters
prostate biopsy fragmentation	within 21 days post biopsy	The number of sections the biopsy specimen is made of

Other

Measure	Time frame	Description
patient experience / pain	at the time of rectal ultrasound probe insertion, estimated to a timeframe of 5-30 seconds.	Numeric rating Pain Scale rating from 0-10
14 day complications	14 days	Any complications related to the biopsy (example infection, bleeding)
30 day complications	30 days	Any complications related to the biopsy (example infection, bleeding)

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026