New Biopsy Needle - Evaluation of Prostate Biopsy Quality

NCT04091230 | Completed

• 1 other identifier: 2018/283
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostate Cancer (Diagnosis)

Keywords

biopsy quality

Outcome Measures

Primary Outcomes (1)

• prostate biopsy length (measured by pathologist)

  Length of biopsy specimen in millimeters

  within 21 days post biopsy

Secondary Outcomes (4)

• prostate biopsy fragmentation

  within 21 days post biopsy

• General appearance of biopsy assessed by pathologist (biopsy quality)

  within 21 days post biopsy

• prostate biopsy length (measured in biopsy needle chamber)

  within 21 days post biopsy

• prostate biopsy length (measured in after removal from biopsy chamber)

  within 21 days post biopsy

Other Outcomes (5)

• patient experience / pain

  at the time of rectal ultrasound probe insertion, estimated to a timeframe of 5-30 seconds.

• patient experience / pain

  at the time of injection needle advancement and periprostatic injection of local anesthesia, estimated to a timeframe of 5-10 seconds

• patient experience / pain

  at the time of biopsy sampling.

Study Arms (2)

novel needle

EXPERIMENTAL

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

standard tru cut needle

ACTIVE COMPARATOR

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

Interventions

TRUSbx DEVICE

Trans Rectal UltraSound guided Prostate Biopsy

Also known as: prostate biopsy

novel needle; standard tru cut needle

Eligibility Criteria

• Age: 40 Years - 90 Years
• Gender Eligibility Details: Prostate Biopsy
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible for prostate biopsy
• Signed informed written consent

You may not qualify if:

• None (other than general contra indications for prostate biopsy or patient not willing to participate)

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Helsingborg Hospital

Helsingborg, Skåne County, 254 37, Sweden

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Disease

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Adam Linder, MD, PhD

  Lund University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 10, 2019
• First Posted: September 16, 2019
• Study Start: September 10, 2019
• Primary Completion: October 30, 2019
• Study Completion: November 1, 2019
• Last Updated: February 10, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)