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
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Device: Software for acquiring ultrasound and endoscopic images||Not Applicable|
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 (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|
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
- Percent of surgical needles visible under the ultrasound modality (once inserted in the prostate) [ Time Frame: 1year ]
- Percent of data(ultrasound and endoscopic) on which the merging works [ Time Frame: 1year ]
- Percent of accurate merging [ Time Frame: 1year ]the merging is accurate if its error is under 5mm
- 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
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
|Urology, University hospital of Grenoble|
|Grenoble, Isère, France, 38000|
|Principal Investigator:||Jean-Alexandre Long, MD||University Hospital, Grenoble|