Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-01-04 @ 6:07 PM
Study NCT ID:
NCT03561857
Status:
UNKNOWN
Last Update Posted:
2019-01-28
First Post:
2018-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial for a Robotic Endomicroscopy to Better Define Resection Strategies Applied to Urology Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-24', 'studyFirstSubmitDate': '2018-05-22', 'studyFirstSubmitQcDate': '2018-06-18', 'lastUpdatePostDateStruct': {'date': '2019-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Ease of use of the endomicroscopy device', 'timeFrame': '1 year', 'description': 'The ease of use of the endomicroscopy device will be assessed using a questionnaire that the surgeon will fill at the end of each procedure'}, {'measure': 'Audio/video telecommunication quality', 'timeFrame': '1 year', 'description': 'The telecommunication quality will be assessed using a questionnaire that the surgeon and the anatomopathologist will fill at the end of each procedure'}, {'measure': 'Number of participants with CLE imaging-related adverse events as assessed by CTCAE v5.0', 'timeFrame': '1 year', 'description': 'The device safety will measure by assessing the occurence and severity of adverse events during the study'}, {'measure': 'Stability and reproducibility of images/sequences during procedures', 'timeFrame': '1 year', 'description': 'The stability and reproducibility of endomicroscopy images will be assessed using a questionnaire that the surgeon and the anatomopathologist will fill at the end of each procedure'}], 'primaryOutcomes': [{'measure': 'pCLE criteria', 'timeFrame': '1 year', 'description': 'Definition of pCLE criteria for normal and abnormal prostate tissues'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'This multicenter study aimed at assessing the feasibility of Probe-based Confocal Laser Endomicroscopy (pCLE) during Robotic-Assisted Radical Prostatectomy or Laparoscopic Radical Prostatectomy for intra-operative characterisation of surgical margins.', 'detailedDescription': "Prostate cancer is one of the most diagnosed cancer in men. Several treatments are available depending on patient's clinical features. When the cancer is localised or locally advanced, one of the possible treatment is Radical Prostatectomy. A risk of that procedure is the incomplete removal of cancer tissues due to the presence of cancer cells within the resection margin. A histological analysis of the resected prostate allows to assess surgical margins. If cancer cells comes out to the edges of the removed tissue, it is called Positive Surgical Margin (PSM). Several studies showed that PSMs are more frequent in case of extra-prostatic extensions of the cancer and are correlated with biochemical recurrence.\n\nA study conducted on 21 patients scheduled for Robotic-Assisted Radical Prostatectomy has already demonstrated the feasibility of the intra-operative observation of microscopic features of prostatic and periprostatic tissues in vivo and ex vivo with the Cellvizio® 100 Series system combined with the CelioFlex™ probe.\n\nThe main objective of the study is to assess the feasibility and safety of pCLE technology during radical prostatectomy (RP) and to assess the diagnostic performance of pCLE technology for the definition of the resection margins.\n\nThis method could be used to guide surgeons during nerve sparing surgery and provide real-time feedback for adequate dissection of NVB. As well, ex vivo characterisation of benign and cancerous glandular structures could provide an efficient and rapid method for intra-operative surgical margin assessment\n\nThe study is divided in 2 parts:\n\n1. Ex vivo study\n\n An ex vivo study will be carried out on 15 firsts prostate specimens for pathologist training and generation of ex vivo pCLE images atlas.\n2. In vivo study\n\nPrior to pCLE analysis, a contrast agent (Fluorescein) will be administered:\n\n* by intravenous injection in each prostatic pedicles before their ligation\n* topically, after NVB dissection, in a spray solution through a catheter inserted in an assistant trocar or with a soaked gauze.\n\nThe Cellvizio will be used during the NVB dissection to acquire in vivo images and sequences of prostatic tissues."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 18 years\n* Localised or locally advanced prostate cancer\n* Agreement given for Radical Prostatectomy\n* Not eligible or refusing an active surveillance protocol\n* having given its signed informed consent\n\nExclusion Criteria:\n\n* Under 18 years\n* Previously treated for PCa (hormones, EBRT, focal treatments)\n* Surgical history of BPH treatment\n* Known allergy to Fluorescein'}, 'identificationModule': {'nctId': 'NCT03561857', 'acronym': 'PERSEE II', 'briefTitle': 'Clinical Trial for a Robotic Endomicroscopy to Better Define Resection Strategies Applied to Urology Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mauna Kea Technologies'}, 'officialTitle': "Essais Clinique Pour Une Endomicroscopie Robotisée Dans la redéfinition Des Stratégies d'ExérèsE (PERSÉE) appliquée à la Chirurgie de la Prostate", 'orgStudyIdInfo': {'id': 'MKT-2018-PERSEE-02'}, 'secondaryIdInfos': [{'id': '2018-A01242-53', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Confocal Laser Endomicroscopy', 'description': 'All included patients will undergo probe-based Confocal Laser Endomicroscopy during Robotic-Assisted Radical Prostatectomy (RARP) or Laparoscopic Radical Prostatectomy (LRP)', 'interventionNames': ['Device: Confocal Laser Endomicroscopy']}], 'interventions': [{'name': 'Confocal Laser Endomicroscopy', 'type': 'DEVICE', 'otherNames': ['probe-based Confocal Laser Endomicroscopy', 'CelioFlex probe', 'Cellvizio 100 series', 'pCLE'], 'description': 'The study is divided in 2 parts.\n\n1. Ex vivo study\n\n * Prostate specimens will be stained using Fluorescein\n * Images/sequences of normal and abnormal prostatic tissues, and peri-prostatic tissues will be acquired.\n2. In vivo study\n\n * Intravenous injection of contrast agent\n * pCLE imaging every 5mm of the NVB dissection zone.', 'armGroupLabels': ['Confocal Laser Endomicroscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75012', 'city': 'Paris', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Alexandre Colau, MD', 'role': 'CONTACT'}, {'name': 'Alexandre Colau, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Groupe Hospitalier Diaconesses Croix Saint-Simon', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75014', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Eric Barret, MD', 'role': 'CONTACT', 'email': 'eric.barret@imm.fr', 'phone': '01 56 61 62 63'}, {'name': 'Eric Barret, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institut Mutualiste Montsouris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Eric Barret, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Mutualiste Montsouris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mauna Kea Technologies', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}