Clinical Trials Directory

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

TypeNameDescription
DEVICEconfocal laser endomicroscopyprobe-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.