Clinical trial · Interventional
Improvement of RARP Outcomes Via 3D Printed/Virtual Prostate Models
Improvement of Robotic-assisted Radical Prostatectomy (RARP) Outcomes Via Automatedly Segmented 3D Printed and Virtual Prostate Models: a Feasibility Study
- 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)
Study the effect 3D printed or 3D virtual prostate models of a patient, when manipulated by surgeons during RARP, has on positive surgical margins and functional outcomes of patients. Our main hypothesis is that there is a reduction of positive resection margins and functional outcomes of patients undergoing RARP when surgeons are presented with 3D printed or 3D virtual patient-specific prostate models during surgery. Specifically, we hypothesize that the anatomical knowledge of surgeons that results from the manipulation of 3D printed/virtual models constructed from automated segmentations reduces positive resection margins and functional outcomes.
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 | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3D Printed Models (3D printing facilities at GSTT) | Device | — | UNRESOLVED |
| 3D Virtual Models (Innersight Labs) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 3D Printed Models
- description
- This cohort will consist of 54 prospective cases whereby patient-specific 3D printed models will be available to the surgeon during RARP for manipulation.
- interventionNames
- Device: 3D Printed Models (3D printing facilities at GSTT)
- type
- EXPERIMENTAL
- label
- 3D Virtual Models
- description
- This cohort will consist of 54 prospective cases whereby 3D virtual models will be available to the surgeon during RARP for manipulation using Innersight Labs platform.
- interventionNames
- Device: 3D Virtual Models (Innersight Labs)
Primary outcomes (4)
- measure
- Automated segmentation metrics
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Eligible for RARP after assessment of mp-MRI during multi-disciplinary team meetings at Guy's Hospital * T2b-T3 prostate cancer patients * Gleason's score\>=3+4 . Exclusion Criteria: * prior treatment for prostate cancer * patients with pre-existing urinary incontinence problems * patients where mp-MRI scans are not possible * patients participating in other studies investigating functional outcomes after surgery will be excluded. This is to avoid other studies influencing our secondary endpoints.
References
Publications (0)
Data not yet available