New Biopsy Needle - Evaluation of Prostate Biopsy Quality

Not Applicable

Completed

• Conditions: Prostate Cancer (Diagnosis)
• Interventions: Device: TRUSbx

• Registration Number: NCT04091230
• Lead Sponsor: Region Skane

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 Timeline

• Study Start: 2019-09-10
• Study First Submitted: 2019-09-10
• Study First Submitted QC: 2019-09-13
• Study First Posted: 2019-09-16
• Primary Completion: 2019-10-30
• Study Completion: 2019-11-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-05
• Last Update Posted: 2021-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
prostate biopsy length (measured by pathologist)	within 21 days post biopsy	Length of biopsy specimen in millimeters

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Helsingborg Hospital; 🇸🇪 Helsingborg, Scania, Sweden