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2014-10
2015-10
2015-10
30
NCT02312167
Institut Mutualiste Montsouris
Institut Mutualiste Montsouris
INTERVENTIONAL
Feasibility Study for Robotic Endomicroscopy to Better Define Resection Strategies (PERSEE)
This study aims at demonstrating the feasibility of probe-based confocal laser endomicroscopy (pCLE) and needle-based confocal laser endomicroscopy (nCLE). Contraindications for resection surgery may sometimes be missed during exploratory surgical procedures. That may lead to an incomplete thus useless surgery and delay the right treatment. The objectives of this study are to improve the detection of cancer extension during exploratory procedures and to guide resection to ensure clear margins.
This study involves several innovations including : * the robotization of the confocal miniprobe for a better an d more precise handling of the probe * the use of different contrast agent and administration mode (Fluorescein, Patented Blue V, Indocyanine Green via intravenous, interstitial or topical administration) * the communication between the operative room and the pathologist room for a real time assessment by the surgeon and by the pathologist of the endomicroscopic images
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2014-11-28 | N/A | 2016-02-10 |
2014-12-05 | N/A | 2016-02-11 |
2014-12-09 | N/A | 2014-12 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: confocal laser endomicroscopy confocal laser endomicroscopy : 10 to 15 minutes endomicroscopy procedure to obtain real time microscopical images of healthy and malignant tissue of the targeted organs | DEVICE: confocal laser endomicroscopy
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| The number of participants with adverse events, their type and severity | 8 months |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| The ease of manipulation of the robotized probe (grade 1 to 5) | during or after each procedure, the surgeon is asked to assess the ease of manipulation of the device | 8 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
