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

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ClinicalTrials.gov Identifier: NCT01705405
Recruitment Status : Terminated (due to a problem of device)
First Posted : October 12, 2012
Last Update Posted : October 18, 2016
Sponsor:
Collaborators:
TIMC-IMAG
Clinical Investigation Centre for Innovative Technology Network
Information provided by (Responsible Party):
AdministrateurCIC, University Hospital, Grenoble

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

Condition or disease Intervention/treatment Phase
Prostate Cancer Device: Software for acquiring ultrasound and endoscopic images Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Merging of Endoscopic and Ultrasound Images for Laparoscopic Surgery
Study Start Date : October 2012
Actual Primary Completion Date : August 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy Ultrasound

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




Primary Outcome Measures :
  1. Percent of surgical needles visible under the ultrasound modality (once inserted in the prostate) [ Time Frame: 1year ]

Secondary Outcome Measures :
  1. Percent of data(ultrasound and endoscopic) on which the merging works [ Time Frame: 1year ]
  2. Percent of accurate merging [ Time Frame: 1year ]
    the merging is accurate if its error is under 5mm

  3. 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



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01705405


Locations
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France
Urology, University hospital of Grenoble
Grenoble, Isère, France, 38000
Sponsors and Collaborators
AdministrateurCIC
TIMC-IMAG
Clinical Investigation Centre for Innovative Technology Network
Investigators
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Principal Investigator: Jean-Alexandre Long, MD University Hospital, Grenoble

Additional Information:
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Responsible Party: AdministrateurCIC, principal investigator, University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01705405     History of Changes
Other Study ID Numbers: DCIC 12 06
First Posted: October 12, 2012    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: October 2016
Keywords provided by AdministrateurCIC, University Hospital, Grenoble:
cancer
prostate
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases