Evaluation of Length and Quality of Prostate Biopsies Taken by a New Biopsy Needle
NCT ID: NCT04880681
Last Updated: 2023-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2021-05-17
2024-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Novel needle
Novel needle (18 G, 25 cm with 19 mm sample notch) in a new actuator.
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 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).
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Signed informed written consent
Exclusion Criteria
40 Years
MALE
No
Sponsors
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Region Skane
OTHER
Responsible Party
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Principal Investigators
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Adam Linder, Ass prof
Role: PRINCIPAL_INVESTIGATOR
Lund University
Locations
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Helsingborg Hospital
Helsingborg, Skåne County, Sweden
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Related Links
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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
Other Identifiers
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double needle
Identifier Type: -
Identifier Source: org_study_id
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