Clinical trial · Interventional
Nerve-sparing, Robot-assisted Radical Prostatectomy Using a Personalized, 3D-printed Prostate Model for Selective Resection of Positive Surgical Margins
NCT05960669CI-TRIAL-00068303AURORAcompletedN/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)
To optimize precision for secondary resection (SR) in frozen section (FS) controlled nerve-sparing robot-assisted radical prostatectomy (NS-RARP) by using a personalized 3D-printed prostate model.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3D model guided secondary resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 3D model guided SR
- description
- A prostate model was 3D printed from preoperative pelvic MRI data and used during surgery to mark a positive surgical margin and guide secondary resection.
- interventionNames
- Procedure: 3D model guided secondary resection
Primary outcomes (1)
- measure
- comparison of the primary surgical margin status in the FS with the tissue of the resulting SR and with the final surgical margin status
- timeFrame
- 4 weeks
Secondary outcomes (2)
- measure
- Erectile function
- timeFrame
- 1 year
- description
- IIEF-5
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * preoperatively planed and intraoperatively performed nerve-sparing approach (at least unilateral) * suitable pelvic MRI for the creation of a personalized 3D prostate model, * written patient consent Exclusion Criteria: * no nerve sparing performed
References
Publications (0)
Data not yet available
No reference posted for this study.