Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT06660758
Status:
RECRUITING
Last Update Posted:
2025-07-11
First Post:
2024-10-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pilot Study of the Entarik System With Advanced Functionality in Health Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004750', 'term': 'Enteral Nutrition'}], 'ancestors': [{'id': 'D005248', 'term': 'Feeding Methods'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D018529', 'term': 'Nutritional Support'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-08', 'studyFirstSubmitDate': '2024-10-24', 'studyFirstSubmitQcDate': '2024-10-25', 'lastUpdatePostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Freedom from device-related adverse events', 'timeFrame': 'From enrollment to end of study (1 day)', 'description': 'The incidence and severity of Adverse Events (AEs) including device and procedure-related AEs and the incidence and severity of Serious Adverse Events (SAEs) will be evaluated throughout the study.\n\nBased on the non-invasive nature of the device and clinical experience gained to date, there are expected to be no SAEs nor Unanticipated Adverse Device Effects (UADEs) in the study. If any SAEs or UADEs occur they will be documented and reported, but there are no planned formal hypotheses associated with the evaluation of safety.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Healthy Adults']}, 'descriptionModule': {'briefSummary': 'In this single-site study, data will be recorded during nasogastric or orogastric placement (and post-pyloric placement) and removal of the Entarik Feeding Tube. Data will also be collected prior to, during, and following the delivery of a meal through the feeding tube.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. At least 18 years old\n2. Able to provide informed consent\n3. Capable and willing to follow all study-related procedures\n4. Confirmed fasted state for a minimum of 8 hours prior to study initiation\n\nExclusion Criteria:\n\n1. Inability to receive a feeding tube\n2. Known self-reported history of hiatal hernia, esophagitis, esophageal strictures or gastric ulcers\n3. Has a basilar skull fracture\n4. Self-reports pregnancy\n5. Deemed unsuitable for enrollment in study by the investigator based on subjects' history or physical examination"}, 'identificationModule': {'nctId': 'NCT06660758', 'briefTitle': 'Pilot Study of the Entarik System With Advanced Functionality in Health Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gravitas Medical, Inc.'}, 'officialTitle': 'Pilot Study of the Entarik System With Advanced Functionality in Health Adults', 'orgStudyIdInfo': {'id': 'CRD-04-1934-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy Adults', 'description': 'An Entarik feeding tube will be introduced and subjects will receive a meal administered through the feeding tube. Ultrasound and other data will be recorded before, during and after the meal is administered.', 'interventionNames': ['Device: Feeding tube (Entarik)']}], 'interventions': [{'name': 'Feeding tube (Entarik)', 'type': 'DEVICE', 'description': 'Feeding tube placement will be verified using multiple methods in the duodenum and stomach.', 'armGroupLabels': ['Healthy Adults']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94710', 'city': 'Berkeley', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Aaron Miller', 'role': 'CONTACT', 'email': 'clinicalstudy@theranova.com', 'phone': '415-926-8616'}, {'name': 'Thomas Sorrentino, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Daniel Burnett, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Gravitas Medical, Inc.', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}], 'centralContacts': [{'name': 'Director of Clinical', 'role': 'CONTACT', 'email': 'clinicalstudy@theranova.com', 'phone': '415-926-8616'}], 'overallOfficials': [{'name': 'Thomas Sorrentino, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "This is a device development study. Subject data may be shared at a later time at the sponsor's discretion."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gravitas Medical, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Theranova, L.L.C.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}