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New Biopsy Needle - Evaluation of Prostate Biopsy Quality

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ClinicalTrials.gov Identifier: NCT04091230
Recruitment Status : Enrolling by invitation
First Posted : September 16, 2019
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Region Skane

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

Condition or disease Intervention/treatment Phase
Prostate Cancer (Diagnosis) Device: TRUSbx Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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. 12 biopsies are taken from each patient. Biopsy quality is evaluated by the pathologist blinded to device used.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Other
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.
Actual Study Start Date : September 10, 2019
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

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 Name: 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 Name: prostate biopsy




Primary Outcome Measures :
  1. prostate biopsy length [ Time Frame: within 21 days post biopsy ]
    Length of biopsy specimen in millimeters


Secondary Outcome Measures :
  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 [ Time Frame: within 21 days post biopsy ]
    General quality of biopsy specimen on a scale from 0-3 (no biopsy, poor, good, excellent)


Other Outcome Measures:
  1. patient experience / pain [ Time Frame: at the time of rectal ultrasound probe insertion, estimated to a timeframe of 5-30 seconds. ]
    Visual Analog Pain Scale (VAS) 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 ]
    Visual Analog Pain Scale (VAS) rating from 0-10

  3. patient experience / pain [ Time Frame: at the exact time of biopsy sampling, estimated to a timeframe of less than 2 seconds. ]
    Visual Analog Pain Scale (VAS) rating from 0-10



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Prostate Biopsy
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04091230


Locations
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Sweden
Helsingborg Hospital
Helsingborg, Scania, Sweden, 254 37
Sponsors and Collaborators
Region Skane
Investigators
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Principal Investigator: Adam Linder, MD, PhD Lund University

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Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT04091230     History of Changes
Other Study ID Numbers: 2018/283
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Region Skane:
biopsy quality
Additional relevant MeSH terms:
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Prostatic Neoplasms
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases