Merging of Endoscopic and Ultrasound Images for Laparoscopic Surgery

Prostate Cancer Clinical Trial

— FEE  

Official title:

Merging of Endoscopic and Ultrasound Images for Laparoscopic Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01705405
• Other study ID #: DCIC 12 06
• Status: Terminated
• Phase: N/A
• First received: October 5, 2012
• Last updated: October 17, 2016
• Start date: October 2012
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: September 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Prostate Cancer

Intervention

Device:
• Software for acquiring ultrasound and endoscopic images
Use of a medical device to acquire ultrasound and endoscopic images

Locations

Country	Name	City	State
France	Urology, University hospital of Grenoble	Grenoble	Isère

Sponsors (3)

Lead Sponsor	Collaborator
AdministrateurCIC	Clinical Investigation Centre for Innovative Technology Network, TIMC-IMAG

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of surgical needles visible under the ultrasound modality (once inserted in the prostate)		1year	No
Secondary	Percent of data(ultrasound and endoscopic) on which the merging works		1year	No
Secondary	Percent of accurate merging	the merging is accurate if its error is under 5mm	1year	No
Secondary	Percent of mistaken segmentation of the vesical neck in the endoscopic image	The segmentation in the endoscopic image is mistaken if it differs of more than 5mm² from the segmentation in the ultrasound volume	1year	No

External Links

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