Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2026-02-20 @ 10:44 PM
Study NCT ID:
NCT02312167
Status:
COMPLETED
Last Update Posted:
2016-02-11
First Post:
2014-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Study for Robotic Endomicroscopy to Better Define Resection Strategies (PERSEE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D004379', 'term': 'Duodenal Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004378', 'term': 'Duodenal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-10', 'studyFirstSubmitDate': '2014-11-28', 'studyFirstSubmitQcDate': '2014-12-05', 'lastUpdatePostDateStruct': {'date': '2016-02-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'the quality of real time communication between the pathologist lab and the OR (grade 1 to 5)', 'timeFrame': '8 months', 'description': 'during or after each procedure, the surgeon and the pathologists are asked to assess the quality of audiovisual communication'}, {'measure': 'number of interpretable images per organ, per contrast agent and per pathology', 'timeFrame': '8 months', 'description': 'each sequence acquired during the cases will be annotated as to which organ it is, and the final diagnosis of the specimen (healthy, cancerous, inflammation, etc ...). Thanks to this, a more complete atlas of images obtained in digestive organs and conditions will be developed. This atlas will be used to describe image interpretation criteria for endomicroscopic images of various organs and conditions. This work will be done in conjunction by the investigators, the histopathologist, and an Mauna Kea Technologies representative familiar with image interpretation in current endomicroscopy indications.'}], 'primaryOutcomes': [{'measure': 'The number of participants with adverse events, their type and severity', 'timeFrame': '8 months'}], 'secondaryOutcomes': [{'measure': 'The ease of manipulation of the robotized probe (grade 1 to 5)', 'timeFrame': '8 months', 'description': 'during or after each procedure, the surgeon is asked to assess the ease of manipulation of the device'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['endomicroscopy', 'optical biopsy', 'exploratory surgery', 'resection surgery', 'robot-assisted', 'peritoneum carcinosis', 'inflammatory', 'rectum cancer', 'liver cancer', 'ovarian cancer', 'digestive cancer', 'pancreas cancer', 'duodenum cancer'], 'conditions': ['Cancer of Digestive System', 'Ovarian Cancer']}, 'referencesModule': {'references': [{'pmid': '30232616', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'This study aims at demonstrating the feasibility of probe-based confocal laser endomicroscopy (pCLE) and needle-based confocal laser endomicroscopy (nCLE).\n\nContraindications 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.\n\nThe objectives of this study are to improve the detection of cancer extension during exploratory procedures and to guide resection to ensure clear margins.', 'detailedDescription': 'This study involves several innovations including :\n\n* the robotization of the confocal miniprobe for a better an d more precise handling of the probe\n* the use of different contrast agent and administration mode (Fluorescein, Patented Blue V, Indocyanine Green via intravenous, interstitial or topical administration)\n* 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient scheduled for an exploratory surgery or a resection surgery for an abdomino-pelvic cancer\n* patient able to give written informed consent\n\nExclusion Criteria:\n\n* allergy to fluorescein\n* allergy to patented blue\n* allergy to ICG\n* previous life-threatening allergic reactions and known hypersensitivity\n* pregnancy or breast-feeding\n* history of cardio-pulmonary disease (including bronchial asthma)\n* restricted renal function\n* patient under a beta-blockers treatment\n* patient who cannot give written informed consent'}, 'identificationModule': {'nctId': 'NCT02312167', 'acronym': 'PERSEE', 'briefTitle': 'Feasibility Study for Robotic Endomicroscopy to Better Define Resection Strategies (PERSEE)', 'organization': {'class': 'OTHER', 'fullName': 'Institut Mutualiste Montsouris'}, 'officialTitle': 'Essai de faisabilité Pour Une Endomicroscopie Robotisée Dans la redéfinition Des Stratégies d&Apos;ExérèsE', 'orgStudyIdInfo': {'id': 'MKT-2013-PERSEE-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'confocal laser endomicroscopy', 'description': 'confocal laser endomicroscopy : 10 to 15 minutes endomicroscopy procedure to obtain real time microscopical images of healthy and malignant tissue of the targeted organs', 'interventionNames': ['Device: confocal laser endomicroscopy']}], 'interventions': [{'name': 'confocal laser endomicroscopy', 'type': 'DEVICE', 'otherNames': ['optical biopsy', 'Cellvizio'], 'description': 'probe-based and needle-based confocal laser endomicroscopy', 'armGroupLabels': ['confocal laser endomicroscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'state': 'Paris', 'country': 'France', 'facility': 'Mutualiste Montsouris Institute', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Brice GAYET, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mutualiste Montsouris Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Mutualiste Montsouris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mauna Kea Technologies', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}