Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-02-21 @ 10:34 AM
Study NCT ID:
NCT03371160
Status:
TERMINATED
Last Update Posted:
2024-06-18
First Post:
2017-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Feasibility Study to Evaluate Safety of Nutriseal™ Nutriplace™ System
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'anath@envizionmed.com', 'phone': '+972-72-2288240', 'title': 'Clinical Director', 'organization': 'ENvizion Medical (Nutriseal)'}, 'certainAgreement': {'otherDetails': "There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. Twelve months following the completion of the study, Investigator may publish the results of the study. Investigator shall provide sponsor advanced copies of any proposed publication sixty days prior to planned publication Sponsor will have sixty days to review the proposed publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': "From the participant's tube placement procedure (day 0) to the end of of the follow-up visit (20-48 hours post tube placement)", 'description': 'Analysis was performed on all subjects that underwent a tube placement attempt (19 subjects)', 'eventGroups': [{'id': 'EG000', 'title': 'Nutriplace™ System', 'description': 'Placement of the Nutriseal™ Enteral Feeding Tube in the stomach or small intestine of adult patients who require feedings via the oro/nasoenteric route, using the Nutriplace™ System.\n\nNutriplace™ System: The Nutriseal™ Nutriplace™ System is designed to aid qualified operators in the placement of the Nutriseal™ Enteral Feeding Tube™ into the stomach or small intestine.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Successfully Placed Enteral Feeding Tube', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nutriplace™ System', 'description': 'Placement of the Nutriseal™ Enteral Feeding Tube in the stomach or small intestine of adult patients who require feedings via the oro/nasoenteric route, using the Nutriplace™ System.\n\nNutriplace™ System: The Nutriseal™ Nutriplace™ System is an electromagnetic tracking system for feeding tube placement designed to aid qualified operators in the placement of the Nutriseal™ Enteral Feeding Tube™ into the stomach or small intestine.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During procedure visit', 'description': "Enteral tube (EFT) can be placed in the correct anatomical position without occurrence of guidance-related adverse events.\n\nProcedure success was evaluated by comparing tube tip location according to the NUTRIPLACE System and abdominal and/or thoracic X-Ray.\n\nGuidance-related AEs were evaluated through the documentation of any guidance-related serious adverse events (SAE) or adverse events (AE) occurring during a subject's participation in the study.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Of 22 enrolled participants, 19 met inclusion/ exclusion criteria and underwent a tube placement attempt. From these 22 participants, 14 completed a successful tube placement using the ENvue system.\n\nThe study was halted pre-maturely due to a very low enrollment rate at the site.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Requiring Replacement and/or Repositioning of the Feeding Tube', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nutriplace™ System', 'description': 'Placement of the Nutriseal™ Enteral Feeding Tube in the stomach or small intestine of adult patients who require feedings via the oro/nasoenteric route, using the Nutriplace™ System.\n\nNutriplace™ System: The Nutriseal™ Nutriplace™ System is designed to aid qualified operators in the placement of the Nutriseal™ Enteral Feeding Tube™ into the stomach or small intestine.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During procedure visit', 'description': 'Number of placement attempts was evaluated by number of replacement and repositioning events, as defined below:\n\n* Replacement: Complete removal of the tube from the patient or retraction above the level of the pharynx followed by reinsertion\n* Repositioning: Changing position of tube without complete removal of the tube', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Retrograde Tube Migration in the Follow-up Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nutriplace™ System', 'description': 'Placement of the Nutriseal™ Enteral Feeding Tube in the stomach or small intestine of adult patients who require feedings via the oro/nasoenteric route, using the Nutriplace™ System.\n\nNutriplace™ System: The Nutriseal™ Nutriplace™ System is designed to aid qualified operators in the placement of the Nutriseal™ Enteral Feeding Tube™ into the stomach or small intestine.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During follow-up visit (20-48 hours post tube placement', 'description': 'Tube Migration was defined as: Retrograde migration from desired placement position', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nutriplace™ System', 'description': 'Placement of the Nutriseal™ Enteral Feeding Tube in the stomach or small intestine of adult patients who require feedings via the oro/nasoenteric route, using the Nutriplace™ System.\n\nNutriplace™ System: The Nutriseal™ Nutriplace™ System is designed to aid qualified operators in the placement of the Nutriseal™ Enteral Feeding Tube™ into the stomach or small intestine.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'Completed Data Collection of Primary Endpoint', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Of 22 enrolled participants, 19 met inclusion/ exclusion criteria and underwent a tube placement attempt. From these 22 participants, 14 completed a successful tube placement.', 'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Nutriplace™ System', 'description': 'Placement of the Nutriseal™ Enteral Feeding Tube in the stomach or small intestine of adult patients who require feedings via the oro/nasoenteric route, using the Nutriplace™ System.\n\nNutriplace™ System: The Nutriseal™ Nutriplace™ System is designed to aid qualified operators in the placement of the Nutriseal™ Enteral Feeding Tube™ into the stomach or small intestine.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.5', 'groupId': 'BG000', 'lowerLimit': '23', 'upperLimit': '95'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black or African American', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-04', 'size': 632852, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-03-28T15:56', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'whyStopped': 'Low recruitment rate', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'dispFirstSubmitDate': '2020-08-10', 'completionDateStruct': {'date': '2018-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-22', 'studyFirstSubmitDate': '2017-12-01', 'resultsFirstSubmitDate': '2024-04-02', 'studyFirstSubmitQcDate': '2017-12-07', 'dispFirstPostDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-22', 'studyFirstPostDateStruct': {'date': '2017-12-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Successfully Placed Enteral Feeding Tube', 'timeFrame': 'During procedure visit', 'description': "Enteral tube (EFT) can be placed in the correct anatomical position without occurrence of guidance-related adverse events.\n\nProcedure success was evaluated by comparing tube tip location according to the NUTRIPLACE System and abdominal and/or thoracic X-Ray.\n\nGuidance-related AEs were evaluated through the documentation of any guidance-related serious adverse events (SAE) or adverse events (AE) occurring during a subject's participation in the study."}], 'secondaryOutcomes': [{'measure': 'Number of Participants Requiring Replacement and/or Repositioning of the Feeding Tube', 'timeFrame': 'During procedure visit', 'description': 'Number of placement attempts was evaluated by number of replacement and repositioning events, as defined below:\n\n* Replacement: Complete removal of the tube from the patient or retraction above the level of the pharynx followed by reinsertion\n* Repositioning: Changing position of tube without complete removal of the tube'}, {'measure': 'Number of Participants Reporting Retrograde Tube Migration in the Follow-up Visit', 'timeFrame': 'During follow-up visit (20-48 hours post tube placement', 'description': 'Tube Migration was defined as: Retrograde migration from desired placement position'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Enteral Nutrition']}, 'descriptionModule': {'briefSummary': 'This is a single center, non-randomized feasibility clinical evaluation that is designed to affirm the safety of the Nutriplace™ System guidance during the placement of the Nutriseal™ enteral feeding tubes.', 'detailedDescription': 'Enteral nutrition is the preferred route for the provision of nutritional support in most critical ill patients with functional gastrointestinal tract. Achieving early enteral nutrition (EN) in critically ill patients is associated with fewer major complications, reduced mortality and length of hospital stay, and significant cost savings.\n\nIt is estimated that approximately 1.2 million feeding tubes are placed blindly each year in the United States alone. Despite the obvious advantages of the enteral tube feeding, inadvertent placement of enteral feeding tube (EFT) into the airway is relatively common and can result in significant pulmonary injury including pneumothorax and pneumonia. Airway misplacement occurs in 1.2-4 % of blind EFT insertions, with 0.2 to 1.2% of all the feeding tube placements cause pulmonary complications to patients.\n\nThe gold standard for detecting inadvertent placement of a feeding tube in the lungs is radiography. However, because of its cost, possible delay of feedings while waiting for radiography, and risk for radiation exposure, clinicians continue to seek for alternative methods to confirm correct placement.\n\nAll the above mentioned, emphasizes the fact that safe and effective delivery of nasoenteral tube feedings requires assurance that the feeding tube tip is in a proper position.\n\nThe Nutriplace™ System is an electromagnetic tracking system which tracks the path of the feeding tube during placement.\n\nThe benefit of the system when EFT is misdirected into the pulmonary system is a real-time visual tracing, which may prompt users to withdraw the tube and reinsert it.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients must be \\>21 years of age\n2. Patients must require placement of a nasoenteral feeding tube\n3. Patients have an endotracheal tube, OR Do not have an endotracheal tube but are sedated (RASS score of -2 or less) and/or obtunded (Glasgow Coma scale of 9-12)\n4. Patients or legal authorized representative must be able to understand and adhere to all protocol procedures and be willing and able to provide written informed consent\n\nExclusion Criteria:\n\n1. Patients must not have a history of:\n\n * Esophageal varices or ulcers\n * Upper airway obstruction\n * Upper GI stenosis or obstruction\n * Trauma involving sinuses, nares face or neck that would prevent Nasogastriv (NG) tube insertion\n * Deformities of the sinus cavities and/or skull base\n * Esophageal cancer or neoplasm\n2. Patients must not have a significant concomitant illness that would adversely affect their participation in the study\n3. Female patients who are pregnant or lactating'}, 'identificationModule': {'nctId': 'NCT03371160', 'briefTitle': 'Feasibility Study to Evaluate Safety of Nutriseal™ Nutriplace™ System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nutriseal L.P'}, 'officialTitle': 'A Feasibility Study to Evaluate the Clinical Safety of Nutriseal™ Enteral Feeding Tube Placement Using the Nutriseal™ Nutriplace™ System in Patients', 'orgStudyIdInfo': {'id': 'NUTRI001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nutriplace™ System', 'description': 'Placement of the Nutriseal™ Enteral Feeding Tube in the stomach or small intestine of adult patients who require feedings via the oro/nasoenteric route, using the Nutriplace™ System.', 'interventionNames': ['Device: Nutriplace™ System']}], 'interventions': [{'name': 'Nutriplace™ System', 'type': 'DEVICE', 'description': 'The Nutriseal™ Nutriplace™ System is an electromagnetic tracking system for feeding tube placement designed to aid qualified operators in the placement of the Nutriseal™ Enteral Feeding Tube™ into the stomach or small intestine.', 'armGroupLabels': ['Nutriplace™ System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'May Olayan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nutriseal L.P', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}