New Biopsy Needle - Evaluation of Prostate Biopsy Quality
NCT ID: NCT04091230
Last Updated: 2021-02-10
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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COMPLETED
NA
20 participants
INTERVENTIONAL
2019-09-10
2019-11-01
Brief Summary
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Detailed Description
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The investigators have in an ex-vivo setting previously shown a drastic reduction in bacterial transfer across the colon wall using a novel biopsy needle designed to minimize bacterial transfer. Biopsy of prostatectomy specimen using the novel needle has shown biopsy quality equal to the tru cut biopsy needle used today.
This is the first human pilot aiming to evaluate if biopsy quality of the novel needle is equal to the reference 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
TRUSbx using the 18 gauge (G) 25 centimeter(cm) novel needle with 19 millimeter (mm) sample notch and a new actuator. 12 biopsies / patient.
TRUSbx
Trans Rectal UltraSound guided Prostate Biopsy
standard tru cut needle
TRUSbx using a standard tru cut biopsy needle (Mermaid Medical M-biopsy 18G 25 cm biopsy needle with a 19 mm sample notch) in a standard actuator ( Moller Medical Blue RBG-1000-10-1000). 12 biopsies/ patient.
TRUSbx
Trans Rectal UltraSound guided Prostate Biopsy
Interventions
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TRUSbx
Trans Rectal UltraSound guided Prostate Biopsy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Signed informed written consent
Exclusion Criteria
40 Years
90 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, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Lund University
Locations
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Helsingborg Hospital
Helsingborg, Skåne County, Sweden
Countries
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Other Identifiers
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2018/283
Identifier Type: -
Identifier Source: org_study_id
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