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.

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

Study Overview

• Status: Completed
• Conditions: Prostate Cancer (Diagnosis)
• Intervention / Treatment: Device: TRUSbx

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Scania
    • Helsingborg, Scania, Sweden, 254 37
      • Helsingborg Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: novel needle; TRUSbx using the 18 gauge (G) 25 centimeter(cm) novel needle with 19 millimeter (mm) sample notch and a new actuator. 12 biopsies / patient.	Device: TRUSbx; Trans Rectal UltraSound guided Prostate Biopsy; Other Names: prostate biopsy
Active Comparator: standard tru cut needle; 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.	Device: TRUSbx; Trans Rectal UltraSound guided Prostate Biopsy; Other Names: prostate biopsy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Region Skane
• Investigators: Principal Investigator: Adam Linder, MD, PhD, Lund University

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2019
• Primary Completion (Actual): October 30, 2019
• Study Completion (Actual): November 1, 2019

Study Registration Dates

• First Submitted: September 10, 2019
• First Submitted That Met QC Criteria: September 13, 2019
• First Posted (Actual): September 16, 2019

Study Record Updates

• Last Update Posted (Actual): February 10, 2021
• Last Update Submitted That Met QC Criteria: February 5, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: biopsy quality
• Additional Relevant MeSH Terms: Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Neoplasms; Prostatic Neoplasms
• Other Study ID Numbers: 2018/283

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No