Merging of Endoscopic and Ultrasound Images for Laparoscopic Surgery

AdministrateurCIC2 enrolled

Overview

Visualize surgical needles inserted in the prostate, under the ultrasound modality.

In order to help the surgeon to remove the prostate during a laparoscopic intervention, our goal is to provide an innovative medical device that merges intra-operative ultrasound and endoscopic images. We have already achieved the proof of concept of a device that merges ultrasound and endoscopic images. The objectives of this clinical trial are to accompany the maturation of the fusion device and to make the initial assessments of its Medical Service. The main difficulty is to visualize markers (surgical needles) under both modalities , in order to merge them.

Study Type

INTERVENTIONAL

Allocation

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

Software for acquiring ultrasound and endoscopic imagesDEVICE

Use of a medical device to acquire ultrasound and endoscopic images

Eligibility

Sex: MALEMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * of-age patient * patient for whom a radical prostatectomy is planned * patient with a prostate volume between 30g and 100g * patient affiliated to the social security or equivalent * Written informed consent Exclusion Criteria: * contraindication * patient who has undergone a significant prostate resection * patient who has undergone a prostate irradiation * patient concerned by the L1121-6 à 8 of the health public code

Locations (1)

Urology, University hospital of Grenoble

Grenoble, Isère, France

Outcomes

Primary Outcomes

Percent of surgical needles visible under the ultrasound modality (once inserted in the prostate)

Time frame: 1year

Secondary Outcomes

Percent of data(ultrasound and endoscopic) on which the merging works

Time frame: 1year

Percent of accurate merging

the merging is accurate if its error is under 5mm

Time frame: 1year

Percent of mistaken segmentation of the vesical neck in the endoscopic image

The segmentation in the endoscopic image is mistaken if it differs of more than 5mm² from the segmentation in the ultrasound volume

Time frame: 1year

Data from ClinicalTrials.gov

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