Evaluation of Length and Quality of Prostate Biopsies Taken by a New Biopsy Needle
NCT04880681 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2023-05-01
Summary
Patient-blinded randomized controlled trial evaluating length and quality of prostate biopsies taken by a novel biopsy needle.
Conditions
- Prostate Cancer (Diagnosis)
Interventions
- 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.
- 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)
Trans Rectal Ultrasound guided Prostate Biopsy using the assigned needle. Approximately 12 biopsies per patient.
Sponsors & Collaborators
-
Region Skane
lead OTHER
Principal Investigators
-
Adam Linder, Ass prof · Lund University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-05-17
- Primary Completion
- 2023-12-30
- Completion
- 2024-02-28
Countries
- Sweden
Study Locations
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