Clinical trial · Interventional
Ultrasound Based Transperineal Robotic Biopsy of the the Prostate
Study of Prostate Cancer Detection With in House Developed Robot
- 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)
The objective of the study is to examine the effectiveness and accuracy of the BioXbot in prostate biopsy as opposed to transrectal biopsy. This evaluation of the efficacy of both the procedures is based on: * Uptake rate * Peripheral zone reachability * Needling accuracy * Procedure execution time * Post operative discomfort or trauma experienced by patient * Quality and type of tissue sample extracted * Adverse and unanticipated side-effects on patient after the procedure and recording any unexpected reactions
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 |
|---|---|---|---|
| Previous Negative Biopsy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Robotic Transperineal Biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Transperineal Biopsy
- description
- Biopsy of the prostate using transperineal approach
- interventionNames
- Procedure: Robotic Transperineal Biopsy
Primary outcomes (1)
- measure
- Cancer Detection
- timeFrame
- 2 years
- description
- to detect any undetected cancer in Patietns undergoing saturation biopsy
Secondary outcomes (1)
- measure
- Accuracy and Repeatability
- timeFrame
- 6 months
- description
- To be accurate in biopsy position (+/- 2mm) and be able to go back to the same position if patient undergoes treatment.
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: * At least one normal previous prostate biopsy and at least 2 weeks since prior prostate biopsy * Increasing prostate-specific antigen (PSA) level * The Investigator has completed a medical history and a physical examination to assure that the subjects meet all study enrollment criteria Exclusion Criteria: * Patient with operative risk ASA ( American Society of Anaesthesia) = or \> 4 * A history of bleeding disorders/coagulopathy or ongoing treatment for this condition * Patients with psychiatric diseases or insufficient cerebral function
References
Publications (0)
Data not yet available