Evaluation of Length and Quality of Prostate Biopsies Taken by a New Biopsy Needle

April 28, 2023 updated by: Region Skane
Patient-blinded randomized controlled trial evaluating length and quality of prostate biopsies taken by a novel biopsy needle.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Prostate biopsy is the golden standard for prostate cancer diagnosis. Transrectal prostate biopsy (TRUSbx) is the most widely used technique. The biopsy chamber of the Tru Cut needle is in general 19 mm. However, it is on average filled only with 13 mm of tissue. Biopsy length is strongly correlated with diagnostic accuracy of prostate cancer.

Additionally, TRUSbx has a high risk of infection due to bacteria being brought across the colon wall. The investigators have shown that a new needle design reduces this bacterial transfer in an ex vivo setting and a previous trial (NCT049091230) has shown non inferior biopsy length when compared to the standard Tru Cut needle. A further improvement of the needle has now been designed aiming to increase biopsy length and quality, with the possible potential to improve prostate cancer diagnosis. This is the first human pilot aiming to evaluate if biopsy length of the novel needle is superior to a standard Tru Cut biopsy needle in prostate biopsy.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Eligible for prostate biopsy
  • Signed informed written consent

Exclusion Criteria:

- None (other than general contraindications for prostate biopsy or patient not willing to participate)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Novel needle
Novel needle (18 G, 25 cm with 19 mm sample notch) in a new actuator.
Device: Novel needle (18 G, 25 cm with 19 mm sample notch) in a new actuator.
Trans Rectal Ultrasound guided Prostate Biopsy using the assigned needle. Approximately 12 biopsies per patient.
Other Names:
  • prostate biopsy
Active Comparator: Standard Tru Cut needle
Standard tru cut biopsy needle (Argon 18G, 25 cm biopsy needle with a 19 mm sample notch) in a standard actuator (Möller Medical Blue RBG-1000-10-1000).
Device: Standard Tru Cut biopsy needle (Argon 18G, 25 cm biopsy needle with a 19 mm sample notch) in a standard actuator (Möller Medical Blue RBG-1000-10-1000)
Trans Rectal Ultrasound guided Prostate Biopsy using the assigned needle. Approximately 12 biopsies per patient.
Other Names:
  • prostate biopsy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
within 21 days post biopsy
Prostate biopsy fragmentation
Time Frame: within 21 days post biopsy
The number of sections the biopsy specimen is made of
within 21 days post biopsy
Prostate biopsy length (measured in biopsy needle chamber)
Time Frame: within 21 days post biopsy
Length of biopsy specimen in millimeters
within 21 days post biopsy
Prostate biopsy length (measured after removal from biopsy chamber)
Time Frame: within 21 days post biopsy
Length of biopsy specimen in millimeters
within 21 days post biopsy

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain from biopsy sampling
Time Frame: At the time of biopsy sampling
Numeric rating Pain Scale rating from 0-10
At the time of biopsy sampling
14 day complications
Time Frame: 14 days after biopsy
Any complications related to the biopsy (example infection, bleeding)
14 days after biopsy
30 day complications
Time Frame: 30 days after biopsy
Any complications related to the biopsy (example infection, bleeding)
30 days after biopsy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Skane

Investigators

  • Principal Investigator: Adam Linder, Ass prof, Lund University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 17, 2021

Primary Completion (Anticipated)

December 30, 2023

Study Completion (Anticipated)

February 28, 2024

Study Registration Dates

First Submitted

May 5, 2021

First Submitted That Met QC Criteria

May 5, 2021

First Posted (Actual)

May 11, 2021

Study Record Updates

Last Update Posted (Actual)

May 1, 2023

Last Update Submitted That Met QC Criteria

April 28, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • double needle

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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