Prostate CancerFEENCT01705405
Merging of Endoscopic and Ultrasound Images for Laparoscopic Surgery
A study testing Software for acquiring ultrasound and endoscopic images in people with Prostate Cancer, run by AdministrateurCIC at 1 site in France.
Trial summary
Visualize surgical needles inserted in the prostate, under the ultrasound modality. Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Software for acquiring ultrasound and endoscopic images
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2012to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Prostate Cancer
- Being tested
- Software for acquiring ultrasound and endoscopic images
- Keywords
- cancer, prostate
- Medical subject headings
- Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Software for acquiring ultrasound and endoscopic imagesDevice
Use of a medical device to acquire ultrasound and endoscopic images
| Study group | Role | What they receive |
|---|---|---|
| medical device | Experimental | medical device to acquire ultrasound and endoscopic images during surgery Receives: Device: Software for acquiring ultrasound and endoscopic images |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of surgical needles visible under the ultrasound modality (once inserted in the prostate)
Measured: 1year
Secondary outcomes (3)
Percent of data(ultrasound and endoscopic) on which the merging works
Measured: 1year
Percent of accurate merging
the merging is accurate if its error is under 5mm
Measured: 1year
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
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionAug 2016
- Study completionSep 2016
Why it stopped: due to a problem of device
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdministrateurCIC
- Sponsor type
- University, hospital or other
- Collaborators
- TIMC-IMAG, Clinical Investigation Centre for Innovative Technology Network
- Responsible party
- Sponsor-investigator, AdministrateurCIC, University Hospital, Grenoble
- Investigators
- Jean-Alexandre Long, MD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01705405
- Sponsor's protocol ID
- DCIC 12 06
- Acronym
- FEE
- Status last verified
- Oct 2016
- First submitted
- 5 Oct 2012
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Merging of Endoscopic and Ultrasound Images for Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT01705405
- Acronym / sponsor ID
- FEE / DCIC 12 06
- Conditions
- Prostate Cancer
- Keywords
- cancer, prostate
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to a problem of device
- Enrolment
- 2 participants (actual)
- Lead sponsor
- AdministrateurCICUniversity, hospital or other
- Collaborators
- TIMC-IMAG, Clinical Investigation Centre for Innovative Technology Network
- Study start
- Oct 2012
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 12 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| medical device | Experimental | Device: Software for acquiring ultrasound and endoscopic imagesmedical device to acquire ultrasound and endoscopic images during surgery |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Software for acquiring ultrasound and endoscopic imagesUse of a medical device to acquire ultrasound and endoscopic images | Device | medical device |
Primary outcome
Percent of surgical needles visible under the ultrasound modality (once inserted in the prostate)
Time frame: 1year
3 secondary outcomes
Percent of data(ultrasound and endoscopic) on which the merging works
Time frame: 1year
Percent of accurate merging
Time frame: 1year
Percent of mistaken segmentation of the vesical neck in the endoscopic image
Time frame: 1year
Results and safety
The study was stopped early (reason given: due to a problem of device). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Alexandre Long, MD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Software for acquiring ultrasound and endoscopic images in people with Prostate Cancer, run by AdministrateurCIC at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: due to a problem of device). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of surgical needles visible under the ultrasound modality (once inserted in the prostate) (time frame: 1year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2016.