Robotic Endomicroscopy to Better Define Resection Strategies Applied to Hepatic Surgery

NCT03718078 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-01-24

No results posted yet for this study

Summary

This study aims at assessing the feasibility of Probe-based Confocal Laser Endomicroscopy (pCLE) during laparoscopic hepatic masses resection for intra-operative characterisation of hepatic masses and surgical margins assessment.

Conditions

  • Hepatocarcinoma
  • Hepatic Metastasis
  • Hepatic Tumor

Interventions

DEVICE

Confocal Laser Endomicroscopy

The study is divided in two parts. For the two parts, patients will receive an intravenous injection of indocyanine green: 1. Ex vivo study \- Images/sequences of normal and abnormal hepatic tissues and surgical margins will be acquired on surgical specimens 2. In vivo study - Intra-operative pCLE imaging will be performed on hepatic masses and surgical margins

Sponsors & Collaborators

  • Mauna Kea Technologies

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-31
Primary Completion
2020-01-07
Completion
2020-01-07

Countries

  • France

Study Locations

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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 NCT03718078 on ClinicalTrials.gov