Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-02-21 @ 1:35 AM
Study NCT ID:
NCT02609620
Status:
UNKNOWN
Last Update Posted:
2015-12-31
First Post:
2015-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety & Initial Efficacy of the LunGuard PFT Sys. on Enteral-Fed, Sedated and Mechanically Ventilated Patients Peristaltic Feeding Tube
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2016-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-12-30', 'studyFirstSubmitDate': '2015-11-17', 'studyFirstSubmitQcDate': '2015-11-17', 'lastUpdatePostDateStruct': {'date': '2015-12-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of gastro-esophageal reflux (GER) by 30%', 'timeFrame': '12-24 hours'}, {'measure': 'Continuous esophageal pressure monitoring', 'timeFrame': '12-24 hours'}, {'measure': 'Successful introduction, positioning and removal of the device', 'timeFrame': '12-24 h'}, {'measure': 'Successful enteral feeding', 'timeFrame': '12-24 hours'}], 'secondaryOutcomes': [{'measure': 'Reduction of ventilator associated pneumonia (VAP)', 'timeFrame': '12-24 hours'}, {'measure': 'Reduction of micro-aspirations', 'timeFrame': '12-24 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Gastro-esophageal Reflux']}, 'descriptionModule': {'briefSummary': "This study is designated to test the safety and initial efficacy of the LunGuard's PFT device for reduction of GER.\n\nEnterally-Fed, Sedated and Mechanically Ventilated Critically Ill Patients in the ICU will have the PFT positioned in them and used for feeding of a Nutritional Formula.Samples will be taken by suction on predetermined intervals and analysed for Pepsin A concentration.\n\nThe PFT will be removed upon completion of the study's scheduled routine. Patients in the control group will have a standard polyurethane nasogastric device inserted according to standard procedure, which is considered the gold standard."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Informed consent.\n* Patients who are expected for at least 12 hours to be:\n\n * Mechanically ventilated and sedated.\n * Requiring a nasogastric tube.\n* Included are:\n\n * Patients who have undergone tracheostomy.\n * Patients who require use of pro-kinetic drugs and proton pump inhibitors.\n * All levels of Gastric Residual Volume (GRV)\n\nExclusion Criteria:\n\n* • Patients with a contraindication for insertion of a nasogastric tube.\n* Patients with a known esophageal obstruction, preventing passage of the device.\n* Esophageal disease including: achalasia, hiatal hernia or any other anatomical anomaly and/or esophageal pathology, esophagitis, Zenkers diverticulum, para-esophageal hernia, esophageal varices. (not excluded are minor GERD patients)\n* Acute and severe coagulation disorders\n* (INR\\> 2 or platelets below 30,000)\n* Diabetic patients with documented gastrointestinal neuropathy\n* Pregnancy or lactation\n* Allergy to Silicon\n* Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study."}, 'identificationModule': {'nctId': 'NCT02609620', 'acronym': 'PFT', 'briefTitle': 'Safety & Initial Efficacy of the LunGuard PFT Sys. on Enteral-Fed, Sedated and Mechanically Ventilated Patients Peristaltic Feeding Tube', 'organization': {'class': 'INDUSTRY', 'fullName': 'LunGuard Ltd.'}, 'officialTitle': 'A Single-Center, Open Label, Randomized, Controlled Study to Evaluate the Safety & Initial Efficacy of the LunGuard PFT System, and Its Impact on GER in Enteral-Fed, Sedated and Mechanically Ventilated Critically Ill Patients', 'orgStudyIdInfo': {'id': 'PROT-150630835CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'In the treatment group: The LunGuard Peristaltic Feeding Tube (PFT) will be positioned in the ICU and positioning will be verified by X-ray. Nutritional formula will be fed into the stomach via the feeding lumen of the PFT', 'interventionNames': ['Device: Peristaltic Feeding Tube']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Patients in the control group will have a Convatec Levin Duodenal Tube inserted according to standard procedure, which is considered the gold standard.', 'interventionNames': ['Device: ConvaTec Levin Duodenal Tube']}], 'interventions': [{'name': 'Peristaltic Feeding Tube', 'type': 'DEVICE', 'armGroupLabels': ['Treatment']}, {'name': 'ConvaTec Levin Duodenal Tube', 'type': 'DEVICE', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Adi Ickowicz', 'role': 'CONTACT', 'email': 'adi@medicsense.com', 'phone': '+97239233666', 'phoneExt': '0'}, {'name': 'Gilat Mor', 'role': 'CONTACT', 'email': 'gilat@medicasense.com', 'phone': '+97239233666', 'phoneExt': '4'}], 'overallOfficials': [{'name': 'Philip Biderman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bellinson Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LunGuard Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}