Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT01705405
Status:
TERMINATED
Last Update Posted:
2016-10-18
First Post:
2012-10-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Merging of Endoscopic and Ultrasound Images for Laparoscopic Surgery
Sponsor:
AdministrateurCIC
Organization:
Study Overview
Official Title:
Merging of Endoscopic and Ultrasound Images for Laparoscopic Surgery
Status:
TERMINATED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
due to a problem of device
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FEE
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: