Merging of Endoscopic and Ultrasound Images for Laparoscopic Surgery (FEE)

October 17, 2016 updated by: AdministrateurCIC
Visualize surgical needles inserted in the prostate, under the ultrasound modality.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Isère
      • Grenoble, Isère, France, 38000
        • Urology, University hospital of Grenoble

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: medical device
medical device to acquire ultrasound and endoscopic images during surgery
Device: Software for acquiring ultrasound and endoscopic images
Use of a medical device to acquire ultrasound and endoscopic images

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent of surgical needles visible under the ultrasound modality (once inserted in the prostate)
Time Frame: 1year
1year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of data(ultrasound and endoscopic) on which the merging works
Time Frame: 1year
1year
Percent of accurate merging
Time Frame: 1year
the merging is accurate if its error is under 5mm
1year
Percent of mistaken segmentation of the vesical neck in the endoscopic image
Time Frame: 1year
The segmentation in the endoscopic image is mistaken if it differs of more than 5mm² from the segmentation in the ultrasound volume
1year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AdministrateurCIC

Collaborators

Clinical Investigation Centre for Innovative Technology Network
TIMC-IMAG

Investigators

  • Principal Investigator: Jean-Alexandre Long, MD, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

October 5, 2012

First Submitted That Met QC Criteria

October 11, 2012

First Posted (Estimate)

October 12, 2012

Study Record Updates

Last Update Posted (Estimate)

October 18, 2016

Last Update Submitted That Met QC Criteria

October 17, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCIC 12 06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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