Feasibility Study for Robotic Endomicroscopy to Better Define Resection Strategies (PERSEE) — PERSEE  

Ovarian Cancer Clinical Trial

Official title: Essai de faisabilité Pour Une Endomicroscopie Robotisée Dans la redéfinition Des Stratégies d&Apos;ExérèsE

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer of Digestive System
• Digestive System Neoplasms
• Ovarian Cancer
• Ovarian Neoplasms

• NCT number: NCT02312167
• Study type: Interventional
• Source: Institut Mutualiste Montsouris
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Completion date: October 2015