New Biopsy Needle - Evaluation of Prostate Biopsy Quality

Region Skane

Status: Completed

Conditions: Prostate Cancer (Diagnosis)

Treatments: Device: TRUSbx

Study type: Interventional

Funder types: Other

Identifiers

NCT04091230

2018/283

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: Male

Ages: 40 to 90 years old

Volunteers: No 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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

novel needle

Experimental group

Description:

TRUSbx using the 18 gauge (G) 25 centimeter(cm) novel needle with 19 millimeter (mm) sample notch and a new actuator. 12 biopsies / patient.

Treatment:

Device: TRUSbx

standard tru cut needle

Active Comparator group

Description:

TRUSbx using a standard tru cut biopsy needle (Mermaid Medical M-biopsy 18G 25 cm biopsy needle with a 19 mm sample notch) in a standard actuator ( Moller Medical Blue RBG-1000-10-1000). 12 biopsies/ patient.

Treatment:

Device: TRUSbx