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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04880681
Other study ID # double needle
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 17, 2021
Est. completion date February 28, 2024

Study information

Verified date April 2023
Source Region Skane
Contact Andreas Forsvall
Phone 0046-42-4063121
Email andreas.forsvall@med.lu.se
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date February 28, 2024
Est. primary completion date December 30, 2023
Accepts healthy volunteers No
Gender Male
Age group 40 Years and older
Eligibility 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 Design


Intervention

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.
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.

Locations

Country Name City State
Sweden Helsingborg Hospital Helsingborg Scania

Sponsors (1)

Lead Sponsor Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

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 t — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Pain from biopsy sampling Numeric rating Pain Scale rating from 0-10 At the time of biopsy sampling
Other 14 day complications Any complications related to the biopsy (example infection, bleeding) 14 days after biopsy
Other 30 day complications Any complications related to the biopsy (example infection, bleeding) 30 days after biopsy
Primary Prostate biopsy length (measured by pathologist) Length of biopsy specimen in millimeters within 21 days post biopsy
Secondary Prostate biopsy fragmentation The number of sections the biopsy specimen is made of within 21 days post biopsy
Secondary General appearance of biopsy assessed by pathologist (biopsy quality) General quality of biopsy specimen on a scale from 0-3 (no biopsy, poor, good, excellent) within 21 days post biopsy
Secondary Prostate biopsy length (measured in biopsy needle chamber) Length of biopsy specimen in millimeters within 21 days post biopsy
Secondary Prostate biopsy length (measured after removal from biopsy chamber) Length of biopsy specimen in millimeters within 21 days post biopsy
See also
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Not yet recruiting NCT04079699 - Predicting Prostate Cancer in Elderly Men N/A
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