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

NCT04880681 | Unknown

• 1 other identifier: double needle
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Patient-blinded randomized controlled trial evaluating length and quality of prostate biopsies taken by a novel biopsy needle.

Conditions

Prostate Cancer (Diagnosis)

Keywords

Prostatic Neoplasms; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Prostatic Diseases

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 after removal from biopsy chamber)

  within 21 days post biopsy

Other Outcomes (3)

• Pain from biopsy sampling

  At the time of biopsy sampling

• 14 day complications

  14 days after biopsy

• 30 day complications

  30 days after biopsy

Study Arms (2)

Novel needle

EXPERIMENTAL

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.

Standard Tru Cut needle

ACTIVE COMPARATOR

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)

Interventions

Novel needle (18 G, 25 cm with 19 mm sample notch) in a new actuator. DEVICE

Trans Rectal Ultrasound guided Prostate Biopsy using the assigned needle. Approximately 12 biopsies per patient.

Also known as: prostate biopsy

Novel 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

Trans Rectal Ultrasound guided Prostate Biopsy using the assigned needle. Approximately 12 biopsies per patient.

Also known as: prostate biopsy

Standard Tru Cut needle

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• 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 contraindications 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

RECRUITING

Related Publications (2)

• Forsvall A, Fisher J, Wagenius M, Broman C, Korkocic D, Bratt O, Linder A. Prostate biopsy quality and patient experience with the novel Forsvall biopsy needle - a randomized controlled non-inferiority trial. Scand J Urol. 2021 Jun;55(3):235-241. doi: 10.1080/21681805.2021.1921024. Epub 2021 May 17.

  PMID: 33999764 RESULT

• Forsvall A, Fisher J, Cardoso JFP, Wagenius M, Tverring J, Nilson B, Dahlin A, Bratt O, Linder A, Mohanty T. Evaluation of the Forsvall biopsy needle in an ex vivo model of transrectal prostate biopsy - a novel needle design with the objective to reduce the risk of post-biopsy infection. Scand J Urol. 2021 Jun;55(3):227-234. doi: 10.1080/21681805.2021.1921023. Epub 2021 May 17.

  PMID: 33999753 RESULT

Related Links

• Forsvall et al. Prostate biopsy quality and patient experience with the novel Forsvall biopsy needle - a randomized controlled non-inferiority trial.
• Forsvall et al, Evaluation of the Forsvall biopsy needle in an ex vivo model of transrectal prostate biopsy

MeSH Terms

Conditions

Prostatic Neoplasms; Disease; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Prostatic Diseases

Interventions

Biopsy, Needle

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Punctures; Investigative Techniques

Study Officials

• Adam Linder, Ass prof

  Lund University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreas Forsvall

CONTACT

0046-42-4063121; andreas.forsvall@med.lu.se

Adam Linder, Ass prof

CONTACT

0046-46-171000; adam.linder@med.lu.se

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. All biopsies are taken from behind the back of the patient enabling masking from the patient. To assess masking success, patients will be asked to guess which device was used after the procedure is complete.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 60 patients eligible for prostate biopsy are randomized into 2 arms (30+30 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 length (primary outcome) is evaluated by a pathologist who is blinded to device used.

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 11, 2021
• Study Start: May 17, 2021
• Primary Completion: December 30, 2023
• Study Completion: February 28, 2024
• Last Updated: May 1, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)