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

AdministrateurCIC

Status: Terminated

Conditions: Prostate Cancer

Treatments: Device: Software for acquiring ultrasound and endoscopic images

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT01705405

DCIC 12 06

Details and patient eligibility

About

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

Full 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.

Enrollment: 2 patients

Sex: Male

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

2 participants in 1 patient group

medical device

Experimental group

Description:

medical device to acquire ultrasound and endoscopic images during surgery

Treatment:

Device: Software for acquiring ultrasound and endoscopic images