ClinicalTrials.gg
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

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Phase
Not applicable
Study type
Interventional
Enrollment
2
Allocation
Not applicable
Ages
18 Years to 90 Years
Sex
Male
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 509 studies in Prostatic Neoplasms with a site in France — 92 open to participants now, 156 under way, 50 of them phase 3. Prostatic Neoplasms · France.

Enrollment
400th of 405
2 · median 185
Started
2012
with 15 others
No phase
121 of 509
27 open now
Registered
134th of 509
by date

Among the 509 studies in Prostatic Neoplasms with a site in France, this one is the 400th largest by enrollment of the 405 interventional ones that give a count, is one of 16 that started in 2012, is one of 121 with no phase, and was the 134th registered.

Prostatic Neoplasms

7,047 studies on the registry are indexed under Prostatic Neoplasms; 1,579 are open to participants now.

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Open to participants now

92 of the 509 studies in Prostatic Neoplasms with a site in France are open now. Recruiting first, the newest first:

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All 92 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 1,228 Prostatic Neoplasms studies recruiting now, 927 (75%) set no upper age limit and 76 (6%) stop at 75 or younger; 67 take children under 18; 82 take healthy volunteers.

This study: 18 Years to 90 Years · male · no healthy volunteers.

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02

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.

03

Conditions studied

  • Prostate Cancer

Keywords

  • cancer
  • prostate
04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

Exclusion Criteria:

  • 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

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

06

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

07

Study locations

1 site
  • Urology, University hospital of Grenoble
    Grenoble, Isère 38000, France
08

References and documents

Related links

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2012, a primary completion of Aug 2016 and a completion of Sep 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 5, 2012
First posted
Oct 12, 2012
Start
Oct 2012
Primary completionActual
Aug 2016
CompletionActual
Sep 2016
Last update
Oct 18, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 18, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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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