Prostate Cancer (Diagnosis) Clinical Trial
Official title:
Evaluation of Length and Quality of Prostate Biopsies Taken by a New Biopsy Needle
Patient-blinded randomized controlled trial evaluating length and quality of prostate biopsies taken by a novel biopsy needle.
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) |
Country | Name | City | State |
---|---|---|---|
Sweden | Helsingborg Hospital | Helsingborg | Scania |
Lead Sponsor | Collaborator |
---|---|
Region Skane |
Sweden,
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
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 |
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