Trials / Completed
CompletedNCT02312167
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Institut Mutualiste Montsouris · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
This study involves several innovations including : * the robotization of the confocal miniprobe for a better an d more precise handling of the probe * the use of different contrast agent and administration mode (Fluorescein, Patented Blue V, Indocyanine Green via intravenous, interstitial or topical administration) * the communication between the operative room and the pathologist room for a real time assessment by the surgeon and by the pathologist of the endomicroscopic images
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | confocal laser endomicroscopy | probe-based and needle-based confocal laser endomicroscopy |
Timeline
- Start date
- 2014-10-01
- Primary completion
- 2015-10-01
- Completion
- 2015-10-01
- First posted
- 2014-12-09
- Last updated
- 2016-02-11
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT02312167. Inclusion in this directory is not an endorsement.