Feasibility Study for Robotic Endomicroscopy to Better Define Resection Strategies (PERSEE)

NCT ID: NCT02312167

Last Updated: 2016-02-11

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-10-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Cancer of Digestive System Ovarian Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

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

Group Type EXPERIMENTAL

confocal laser endomicroscopy

Intervention Type DEVICE

probe-based and needle-based confocal laser endomicroscopy

Interventions

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confocal laser endomicroscopy

probe-based and needle-based confocal laser endomicroscopy

Intervention Type DEVICE

Other Intervention Names

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optical biopsy Cellvizio

Eligibility Criteria

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Inclusion Criteria

* patient scheduled for an exploratory surgery or a resection surgery for an abdomino-pelvic cancer
* patient able to give written informed consent

Exclusion Criteria

* allergy to fluorescein
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mauna Kea Technologies

INDUSTRY

Sponsor Role collaborator

Institut Mutualiste Montsouris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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France

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.

Reference Type DERIVED
PMID: 30232616 (View on PubMed)

Other Identifiers

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MKT-2013-PERSEE-01

Identifier Type: -

Identifier Source: org_study_id

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