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Clinical Trial for a Robotic Endomicroscopy to Better Define Resection Strategies Applied to Urology Surgery

NCT03561857 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-01-28

No results posted yet for this study

Summary

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

Interventions

DEVICE

Confocal Laser Endomicroscopy

The study is divided in 2 parts. 1. Ex vivo study * Prostate specimens will be stained using Fluorescein * Images/sequences of normal and abnormal prostatic tissues, and peri-prostatic tissues will be acquired. 2. In vivo study * Intravenous injection of contrast agent * pCLE imaging every 5mm of the NVB dissection zone.

Sponsors & Collaborators

  • Mauna Kea Technologies

    lead INDUSTRY

Principal Investigators

  • Eric Barret, MD · Institut Mutualiste Montsouris

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-16
Primary Completion
2020-06-30
Completion
2020-06-30

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03561857 on ClinicalTrials.gov