Clinical trial · Interventional
Evaluation of Length and Quality of Prostate Biopsies Taken by a New Biopsy Needle
NCT04880681CI-TRIAL-00066074unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Patient-blinded randomized controlled trial evaluating length and quality of prostate biopsies taken by a novel biopsy needle.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer (Diagnosis) | Malignant Prostate Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Novel needle (18 G, 25 cm with 19 mm sample notch) in a new actuator. | Device | — | UNRESOLVED |
| 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) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Novel needle
- description
- Novel needle (18 G, 25 cm with 19 mm sample notch) in a new actuator.
- interventionNames
- Device: Novel needle (18 G, 25 cm with 19 mm sample notch) in a new actuator.
- type
- ACTIVE_COMPARATOR
- label
- Standard Tru Cut needle
- description
- 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).
- interventionNames
- 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)
Primary outcomes (1)
- measure
- Prostate biopsy length (measured by pathologist)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
Show eligibility criteria text
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)
References
Publications (2)
- RESULTForsvall 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. PMID 33999764
- RESULTForsvall 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. PMID 33999753