Feasibility Study for Robotic Endomicroscopy to Better Define Resection Strategies (PERSEE)
NCT ID: NCT02312167
Last Updated: 2016-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2014-10-31
2015-10-31
Brief Summary
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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.
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Detailed Description
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* 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
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
confocal laser endomicroscopy
probe-based and needle-based confocal laser endomicroscopy
Interventions
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confocal laser endomicroscopy
probe-based and needle-based confocal laser endomicroscopy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* patient able to give written informed consent
Exclusion Criteria
* allergy to patented blue
* allergy to ICG
* previous life-threatening allergic reactions and known hypersensitivity
* pregnancy or breast-feeding
* history of cardio-pulmonary disease (including bronchial asthma)
* restricted renal function
* patient under a beta-blockers treatment
* patient who cannot give written informed consent
18 Years
ALL
No
Sponsors
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Mauna Kea Technologies
INDUSTRY
Institut Mutualiste Montsouris
OTHER
Responsible Party
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Principal Investigators
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Brice GAYET, MD
Role: PRINCIPAL_INVESTIGATOR
Mutualiste Montsouris Institute
Locations
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Mutualiste Montsouris Institute
Paris, Paris, France
Countries
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References
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Fuks D, Pierangelo A, Validire P, Lefevre M, Benali A, Trebuchet G, Criton A, Gayet B. Intraoperative confocal laser endomicroscopy for real-time in vivo tissue characterization during surgical procedures. Surg Endosc. 2019 May;33(5):1544-1552. doi: 10.1007/s00464-018-6442-3. Epub 2018 Sep 19.
Other Identifiers
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MKT-2013-PERSEE-01
Identifier Type: -
Identifier Source: org_study_id
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