Suspended

FEEMerging of Endoscopic and Ultrasound Images for Laparoscopic Surgery

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Software for acquiring ultrasound and endoscopic images

Device
Who is being recruted

Urogenital Diseases+7

+ Genital Diseases

+ Genital Diseases, Male

From 18 to 90 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Interventional
Study Start: October 2012
See protocol details

Summary

Principal SponsorAdministrateurCIC
Last updated: October 18, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01705405
Principal SponsorAdministrateurCIC
Last updated: October 18, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

2 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

From 18 to 90 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesGenital Diseases, MaleGenital Neoplasms, MaleNeoplasms by SiteProstatic DiseasesUrogenital NeoplasmsMale Urogenital DiseasesNeoplasmsProstatic Neoplasms

Criteria

5 inclusion criteria required to participate
Written informed consent
of-age patient
patient affiliated to the social security or equivalent
patient for whom a radical prostatectomy is planned
Show More Criteria
4 exclusion criteria prevent from participating
contraindication
patient concerned by the L1121-6 à 8 of the health public code
patient who has undergone a prostate irradiation
patient who has undergone a significant prostate resection

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
medical device to acquire ultrasound and endoscopic images during surgery

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Urology, University hospital of Grenoble

Grenoble, FranceOpen Urology, University hospital of Grenoble in Google Maps
SuspendedOne Study Center