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Completed

NCT Number: NCT04091230

New Biopsy Needle - Evaluation of Prostate Biopsy Quality

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

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Key information

Conditions

Prostate Cancer (Diagnosis) Disease Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

40 year–90 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Helsingborg Hospital

Helsingborg, Skåne County, 254 37, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

TRUSbx

Device

Trans Rectal UltraSound guided Prostate Biopsy

Other names: prostate biopsy

Primary outcomes

  1. prostate biopsy length (measured by pathologist)

    Time frame: within 21 days post biopsy

    Length of biopsy specimen in millimeters

Secondary outcomes

  1. prostate biopsy fragmentation

    Time frame: within 21 days post biopsy

    The number of sections the biopsy specimen is made of

  2. General appearance of biopsy assessed by pathologist (biopsy quality)

    Time frame: within 21 days post biopsy

    General quality of biopsy specimen on a scale from 0-3 (no biopsy, poor, good, excellent)

  3. prostate biopsy length (measured in biopsy needle chamber)

    Time frame: within 21 days post biopsy

    Length of biopsy specimen in millimeters

  4. prostate biopsy length (measured in after removal from biopsy chamber)

    Time frame: within 21 days post biopsy

    Length of biopsy specimen in millimeters

Other outcomes

  1. patient experience / pain

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

    Numeric rating Pain Scale rating from 0-10

  2. patient experience / pain

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

    Numeric rating Pain Scale rating from 0-10

  3. patient experience / pain

    Time frame: at the time of biopsy sampling.

    Numeric rating Pain Scale rating from 0-10

  4. 14 day complications

    Time frame: 14 days

    Any complications related to the biopsy (example infection, bleeding)

  5. 30 day complications

    Time frame: 30 days

    Any complications related to the biopsy (example infection, bleeding)

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Official study 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.

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 16, 2019
Registry last updated
Feb 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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