New Biopsy Needle - Evaluation of Prostate Biopsy Quality

Prostate Cancer (Diagnosis) Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04091230
• Other study ID #: 2018/283
• Status: Completed
• Phase: N/A
• Start date: September 10, 2019
• Est. completion date: November 1, 2019

Study information

• Verified date: February 2021
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 1, 2019
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Neoplasms
• Prostate Cancer (Diagnosis)
• Prostatic Neoplasms

Intervention

Device:
• TRUSbx
Trans Rectal UltraSound guided Prostate Biopsy

Locations

Country	Name	City	State
Sweden	Helsingborg Hospital	Helsingborg	Scania

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	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
Other	patient experience / pain	Numeric rating Pain Scale rating from 0-10	at the time of biopsy sampling.
Other	14 day complications	Any complications related to the biopsy (example infection, bleeding)	14 days
Other	30 day complications	Any complications related to the biopsy (example infection, bleeding)	30 days
Primary	prostate biopsy length (measured by pathologist)	Length of biopsy specimen in millimeters	within 21 days post biopsy
Secondary	prostate biopsy fragmentation	The number of sections the biopsy specimen is made of	within 21 days post biopsy
Secondary	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
Secondary	prostate biopsy length (measured in biopsy needle chamber)	Length of biopsy specimen in millimeters	within 21 days post biopsy
Secondary	prostate biopsy length (measured in after removal from biopsy chamber)	Length of biopsy specimen in millimeters	within 21 days post biopsy