Clinical trial · Interventional
Feasibility Study for Robotic Endomicroscopy to Better Define Resection Strategies (PERSEE)
Essai de faisabilité Pour Une Endomicroscopie Robotisée Dans la redéfinition Des Stratégies d&Apos;ExérèsE
- 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 study aims at demonstrating the feasibility of probe-based confocal laser endomicroscopy (pCLE) and needle-based confocal laser endomicroscopy (nCLE). Contraindications for resection surgery may sometimes be missed during exploratory surgical procedures. That may lead to an incomplete thus useless surgery and delay the right treatment. The objectives of this study are to improve the detection of cancer extension during exploratory procedures and to guide resection to ensure clear margins.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of Digestive System | Malignant Digestive System Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian 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
- confocal laser endomicroscopy : 10 to 15 minutes endomicroscopy procedure to obtain real time microscopical images of healthy and malignant tissue of the targeted organs
- interventionNames
- Device: confocal laser endomicroscopy
Primary outcomes (1)
- measure
- The number of participants with adverse events, their type and severity
- timeFrame
- 8 months
Secondary outcomes (1)
- measure
- The ease of manipulation of the robotized probe (grade 1 to 5)
- timeFrame
- 8 months
- description
- during or after each procedure, the surgeon is asked to assess the ease of manipulation of the device
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * patient scheduled for an exploratory surgery or a resection surgery for an abdomino-pelvic cancer * patient able to give written informed consent Exclusion Criteria: * allergy to fluorescein * allergy to patented blue * allergy to ICG * previous life-threatening allergic reactions and known hypersensitivity * pregnancy or breast-feeding * history of cardio-pulmonary disease (including bronchial asthma) * restricted renal function * patient under a beta-blockers treatment * patient who cannot give written informed consent
References
Publications (1)
- DERIVEDFuks D, Pierangelo A, Validire P, Lefevre M, Benali A, Trebuchet G, Criton A, Gayet B. Intraoperative confocal laser endomicroscopy for real-time in vivo tissue characterization during surgical procedures. Surg Endosc. 2019 May;33(5):1544-1552. doi: 10.1007/s00464-018-6442-3. Epub 2018 Sep 19. PMID 30232616