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TerminatedNCT01705405FEEUpdated Oct 18, 2016

Merging of Endoscopic and Ultrasound Images for Laparoscopic Surgery

An interventional study of Software for acquiring ultrasound and endoscopic images in Prostate Cancer, sponsored by AdministrateurCIC. Terminated at 1 site in France. Open to male participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2016-10-18.

Sponsored by AdministrateurCIC · Not applicable and Interventional

Why this study was terminated
due to a problem of device
Phase
Not applicable
Study type
Interventional
Enrollment
2
Allocation
Not applicable
Ages
18 Years to 90 Years
Sex
Male
01

Study summary

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

Read the 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.

02

Conditions studied

  • Prostate Cancer

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Keywords

  • cancer
  • prostate
03

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
Male
Accepts 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

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
04

Study design

Phase
Not applicable
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
2 participants (actual)

Study arms

  • Experimental
    medical device

    medical device to acquire ultrasound and endoscopic images during surgery

    Device: Software for acquiring ultrasound and endoscopic images

Interventions

  • DeviceSoftware for acquiring ultrasound and endoscopic images

    Use of a medical device to acquire ultrasound and endoscopic images

05

What researchers measure

Primary outcomes

  1. Percent of surgical needles visible under the ultrasound modality (once inserted in the prostate)

    Time frame: 1year

Secondary outcomes

  1. Percent of data(ultrasound and endoscopic) on which the merging works

    Time frame: 1year

  2. Percent of accurate merging

    the merging is accurate if its error is under 5mm

    Time frame: 1year

  3. 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

    Time frame: 1year

06

Study locations

1 site
  • Urology, University hospital of Grenoble
    Grenoble, Isère 38000, France
07

References and documents

Related links

08

Registry details

Key details

Study ID
NCT01705405
Lead sponsor
AdministrateurCIC
Collaborators
TIMC-IMAG, Clinical Investigation Centre for Innovative Technology Network
Responsible party
AdministrateurCIC (principal investigator, University Hospital, Grenoble) — Sponsor-investigator
First posted
Oct 12, 2012
Start date
Oct 2012
Primary completion
Aug 2016
Completion
Sep 2016
Last update
Oct 18, 2016

Study contacts

Jean-Alexandre Long, MD
principal investigator · University Hospital, Grenoble

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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