Prostate Cancer
Conditions
Keywords
cancer, prostate
Brief summary
Visualize surgical needles inserted in the prostate, under the ultrasound modality.
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.
Interventions
DEVICESoftware for acquiring ultrasound and endoscopic images
Use of a medical device to acquire ultrasound and endoscopic images
Sponsors
TIMC-IMAG
Clinical Investigation Centre for Innovative Technology Network
AdministrateurCIC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent of surgical needles visible under the ultrasound modality (once inserted in the prostate) | 1year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of data(ultrasound and endoscopic) on which the merging works | 1year | — |
| Percent of accurate merging | 1year | the merging is accurate if its error is under 5mm |
| Percent of mistaken segmentation of the vesical neck in the endoscopic image | 1year | The segmentation in the endoscopic image is mistaken if it differs of more than 5mm² from the segmentation in the ultrasound volume |
Countries
France
Outcome results
None listed