Clinical trial · Interventional
Clinical Trial for a Robotic Endomicroscopy to Better Define Resection Strategies Applied to Urology Surgery
Essais Clinique Pour Une Endomicroscopie Robotisée Dans la redéfinition Des Stratégies d'ExérèsE (PERSÉE) appliquée à la Chirurgie de la Prostate
NCT03561857CI-TRIAL-00036783PERSEE IIunknownN/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)
This multicenter study aimed at assessing the feasibility of Probe-based Confocal Laser Endomicroscopy (pCLE) during Robotic-Assisted Radical Prostatectomy or Laparoscopic Radical Prostatectomy for intra-operative characterisation of surgical margins.
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 |
|---|---|---|---|
| Confocal Laser Endomicroscopy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Confocal Laser Endomicroscopy
- description
- All included patients will undergo probe-based Confocal Laser Endomicroscopy during Robotic-Assisted Radical Prostatectomy (RARP) or Laparoscopic Radical Prostatectomy (LRP)
- interventionNames
- Device: Confocal Laser Endomicroscopy
Primary outcomes (1)
- measure
- pCLE criteria
- timeFrame
- 1 year
- description
- Definition of pCLE criteria for normal and abnormal prostate tissues
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Over 18 years * Localised or locally advanced prostate cancer * Agreement given for Radical Prostatectomy * Not eligible or refusing an active surveillance protocol * having given its signed informed consent Exclusion Criteria: * Under 18 years * Previously treated for PCa (hormones, EBRT, focal treatments) * Surgical history of BPH treatment * Known allergy to Fluorescein
References
Publications (0)
Data not yet available
No reference posted for this study.