Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2025-12-25 @ 11:08 PM
Study NCT ID:
NCT05651867
Status:
COMPLETED
Last Update Posted:
2025-07-15
First Post:
2022-11-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
EPIONE Guided Lung Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'm.chassouant@quantumsurgical.com', 'phone': '0033781425198', 'title': 'Marion Chassouant', 'organization': 'Quantum Surgical'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'through study completion, an average of 21 months', 'eventGroups': [{'id': 'EG000', 'title': 'Interventional Arm', 'description': 'Patients treated by percutaneous CT-guided procedures in the lung with the EPIONE® device', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 8, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'seriousEvents': [{'term': 'PNEUMOTHORAX', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'ABCESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'pneumapathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Feasibility of the Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}, {'units': 'Number of targets reached', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Interventional Arm', 'description': 'Patients treated by percutaneous CT-guided procedures in the lung with the EPIONE® device\n\nEPIONE device: The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures.'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'an average of 7 months', 'description': 'Number of lesion target reached ; the lesion target is considered reached when the needle is positioned accurately enough as compared to the planning to allow the planned procedure to be performed.', 'unitOfMeasure': 'Number of targets reached', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of targets reached', 'denomUnitsSelected': 'Number of targets reached', 'populationDescription': 'All screened patients who have confirmed their signed informed consent and are planned to be treated using the EPIONE® device.'}, {'type': 'SECONDARY', 'title': 'Needle Placement Accuracy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}, {'units': 'needles', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Interventional Arm', 'description': 'Patients treated by percutaneous CT-guided procedures in the lung with the EPIONE® device'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'spread': '2.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'an average of 7 months', 'description': 'accuracy of the needle placement: deviation between the planned and actual needle position once inserted.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'needles', 'denomUnitsSelected': 'needles', 'populationDescription': 'all patients whose procedure was feasible'}, {'type': 'SECONDARY', 'title': 'Number of Needle Adjustments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}, {'units': 'needle', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Interventional Arm', 'description': 'Patients treated by percutaneous CT-guided procedures in the lung with the EPIONE® device'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'spread': '0.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'an average of 7 months', 'description': 'Detail of the number/nature of adjustments performed after the initial insertion of the needle.', 'unitOfMeasure': 'number of adjustments per needle', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'needle', 'denomUnitsSelected': 'needle', 'populationDescription': 'all patients whose procedure was feasible'}, {'type': 'SECONDARY', 'title': 'Post-intervention Ablation Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}, {'units': 'lesions', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Interventional Arm', 'description': 'Patients treated by percutaneous CT-guided procedures in the lung with the EPIONE® device'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'an average of 1 year', 'description': 'If the ablation zone is at least the lesion size + 5mm, the ablation is considered successfull. The measure counted is the number of success', 'unitOfMeasure': 'lesions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'lesions', 'denomUnitsSelected': 'lesions', 'populationDescription': 'all patients whose procedure was feasible'}, {'type': 'SECONDARY', 'title': 'Long-term Efficacy of Ablation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Interventional Arm', 'description': 'Patients treated by percutaneous CT-guided procedures in the lung with the EPIONE® device'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'If a tumor progresses locally 12 months after the initial treatment, the long-term efficacy of the ablation is considered failed.\n\nWe count here the patient treated for which the lesion ablated did not show recurrence after 12 months.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'all patients whose procedure was feasible and were still in the study after 12 months'}, {'type': 'SECONDARY', 'title': 'Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Interventional Arm', 'description': 'Patients treated by percutaneous CT-guided procedures in the lung with the EPIONE® device'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'through study completion, an average of 21 months', 'description': 'number of patients experiencing a serious adverse event', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'all patients included in the study'}, {'type': 'SECONDARY', 'title': 'Grade of Needle Adjustment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}, {'units': 'needle', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Interventional Arm', 'description': 'Patients treated by percutaneous CT-guided procedures in the lung with the EPIONE® device'}], 'classes': [{'categories': [{'title': 'minor adjutsments', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'medium adjustements', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}, {'title': 'major adjustements', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'no adjustement', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'an average of 7 months', 'description': 'Description of the grade of needle adjustement : minor meaning depth needle adjustment only, medium meaning at lateral needle adjustement (+ or - depth adjustement) or major (meaning complete removal of the needle from the atient body)', 'unitOfMeasure': 'needle', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'needle', 'denomUnitsSelected': 'needle', 'populationDescription': 'all patients who started the procedure with EPIONE'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Interventional Arm', 'description': 'Patients treated by percutaneous CT-guided procedures in the lung with the EPIONE® device'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}]}], 'recruitmentDetails': '25 patients included from 2022-11-30 to 2023-08-25 at the IGR (Villejuif/France).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}, {'units': 'lesions', 'counts': [{'value': '27', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Interventional Arm', 'description': 'Patients treated by percutaneous CT-guided procedures in the lung with the EPIONE® device'}], 'measures': [{'title': 'Age, Continuous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}, {'units': 'lesions', 'counts': [{'value': '27', 'groupId': 'BG000'}]}], 'classes': [{'categories': [{'measurements': [{'value': '64.2', 'spread': '9.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}, {'title': 'Sex: Female, Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}, {'units': 'lesions', 'counts': [{'value': '27', 'groupId': 'BG000'}]}], 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}, {'units': 'lesions', 'counts': [{'value': '27', 'groupId': 'BG000'}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Body Mass Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}, {'units': 'lesions', 'counts': [{'value': '27', 'groupId': 'BG000'}]}], 'classes': [{'categories': [{'measurements': [{'value': '25.2', 'spread': '4.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}], 'typeUnitsAnalyzed': 'lesions', 'populationDescription': 'number of lesions treated with the Epione device'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-05-26', 'size': 967007, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-06-25T05:07', 'hasProtocol': True}, {'date': '2023-04-03', 'size': 1285821, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-05-07T09:32', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-09-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-25', 'studyFirstSubmitDate': '2022-11-28', 'resultsFirstSubmitDate': '2025-05-07', 'studyFirstSubmitQcDate': '2022-12-14', 'lastUpdatePostDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-25', 'studyFirstPostDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of the Device', 'timeFrame': 'an average of 7 months', 'description': 'Number of lesion target reached ; the lesion target is considered reached when the needle is positioned accurately enough as compared to the planning to allow the planned procedure to be performed.'}], 'secondaryOutcomes': [{'measure': 'Needle Placement Accuracy', 'timeFrame': 'an average of 7 months', 'description': 'accuracy of the needle placement: deviation between the planned and actual needle position once inserted.'}, {'measure': 'Number of Needle Adjustments', 'timeFrame': 'an average of 7 months', 'description': 'Detail of the number/nature of adjustments performed after the initial insertion of the needle.'}, {'measure': 'Post-intervention Ablation Success', 'timeFrame': 'an average of 1 year', 'description': 'If the ablation zone is at least the lesion size + 5mm, the ablation is considered successfull. The measure counted is the number of success'}, {'measure': 'Long-term Efficacy of Ablation', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'If a tumor progresses locally 12 months after the initial treatment, the long-term efficacy of the ablation is considered failed.\n\nWe count here the patient treated for which the lesion ablated did not show recurrence after 12 months.'}, {'measure': 'Adverse Event', 'timeFrame': 'through study completion, an average of 21 months', 'description': 'number of patients experiencing a serious adverse event'}, {'measure': 'Grade of Needle Adjustment', 'timeFrame': 'an average of 7 months', 'description': 'Description of the grade of needle adjustement : minor meaning depth needle adjustment only, medium meaning at lateral needle adjustement (+ or - depth adjustement) or major (meaning complete removal of the needle from the atient body)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['percutaneous', 'CT-guided', 'Ablation', 'Biopsy', 'Abcess Drainage', 'Fiducial placement', 'Lung', 'Robotics'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'Interventional clinical study to obtain performance and safety data of the EPIONE® device when used for percutaneous procedures in the lung.', 'detailedDescription': 'The objectives are:\n\n* to evaluate the technical success of the device\n* to evaluate performance parameters (accuracy measures, adjustements, post-intervention ablation success, local tumor recurrence)\n* to evaluate the safety of the device\n\n 25 subjectsare planned and will undergo an intervention, during which the clinician will use the EPIONE device'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient ≥18 years old,\n* Patient for whom a percutaneous CT-guided intervention in lung has been prescribed and agreed by a multidisciplinary team of radiologists, surgeons and clinicians,\n* Patient with a signed informed consent form.\n* Patient covered by a social security system.\n\nExclusion Criteria:\n\n* Patient unable to undergo general anesthesia,\n* Pregnant or nursing female, confirmed before the intervention\n* Patient already participating in another clinical study'}, 'identificationModule': {'nctId': 'NCT05651867', 'acronym': 'EGLE', 'briefTitle': 'EPIONE Guided Lung Evaluation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Quantum Surgical'}, 'officialTitle': 'Prospective Clinical Investigation on the Evaluation of Performance and Safety of the EPIONE Assisted CT-guided Percutaneous Procedures in the Lungs', 'orgStudyIdInfo': {'id': 'QS-IS-G-H-2201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interventional arm', 'description': 'Patients treated by percutaneous CT-guided procedures in the lung with the EPIONE® device', 'interventionNames': ['Device: EPIONE device']}], 'interventions': [{'name': 'EPIONE device', 'type': 'DEVICE', 'description': 'The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures.', 'armGroupLabels': ['Interventional arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94000', 'city': 'Villejuif', 'country': 'France', 'facility': 'Gustave Roussy Institut', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'overallOfficials': [{'name': 'Baptiste BONNET, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gustave Roussy, Cancer Campus, Grand Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Quantum Surgical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}