Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT05962905
Status:
COMPLETED
Last Update Posted:
2025-05-09
First Post:
2023-07-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Accuracy Performance Verification of the INVOS™ System in Pediatrics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-06', 'studyFirstSubmitDate': '2023-07-13', 'studyFirstSubmitQcDate': '2023-07-24', 'lastUpdatePostDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of the root mean square', 'timeFrame': 'At the point of blood sampling during cardiac catheterization procedure', 'description': 'root mean square of the difference in regional oxygen saturation (rSO2) as measured by the INVOS and field saturation (fSO2) as measured by blood sampling'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['cerebral oximetry', 'pediatric', 'infant'], 'conditions': ['Cerebral Oxygenation', 'Pediatric ALL']}, 'descriptionModule': {'briefSummary': 'Prospective, observational, multi-center trial designed to capture calibration and performance evaluation data with the INVOS™ system.', 'detailedDescription': 'The purpose of this study is to verify INVOS™ cerebral oximetry system performance in pediatric and infant patients bycomparing regional oxygen saturation (rSO2) values to reference blood oxygen saturation measurements obtained throughinternal jugular vein and arterial blood convenience sampling according to International Organization on Standards (ISO) 80601-2-85:2021.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '0 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatric patients (under 21) weighing under 40 kg scheduled for a diagnostic or interventional cardiac catheterization procedure with general anesthesia or sedation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Under 21 years of age\n2. Meets weight requirement for sensors under study\n3. Scheduled for a diagnostic or interventional cardiac catheterization procedure with general anesthesia or sedation\n4. Arterial and venous access as part of the planned catheterization procedure\n\nExclusion Criteria:\n\n1. Prior known severe allergies to medical grade adhesive/tape (Band-Aid) \\[self-reported\\]\n2. A skin condition at the sensor site (e.g., rash, abrasion, laceration)\n3. Craniofacial disease producing abnormal forehead anatomy and/or preventing forehead application of the sensor\n4. A known structural brain lesion beneath the sensor\n5. Known hemoglobinopathy\n6. Inability to lie supine with neutral neck position during catheterization\n7. Cerebrovascular disease\n8. An emergent, life threatening condition impacting study conduct\n9. Unwillingness or inability to sign informed consent (IC) or assent by the parents/guardians of child\n10. Currently receiving phototherapy for bilirubin\n11. Arterial or venous anatomy that would preclude obtaining an accurate paired sample\n12. Known pregnancy'}, 'identificationModule': {'nctId': 'NCT05962905', 'acronym': 'INCATH', 'briefTitle': 'Accuracy Performance Verification of the INVOS™ System in Pediatrics', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic - MITG'}, 'officialTitle': 'Medtronic Accuracy Performance Verification of the INVOS™ System in the Pediatric Cardiac Catheterization Laboratory (INCATH)', 'orgStudyIdInfo': {'id': 'MDT23002INCATH'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pediatric', 'description': 'Subjects meeting inclusion criteria weighing between 4 and 40 kg', 'interventionNames': ['Other: Blood sample', 'Device: INVOS monitoring']}, {'label': 'Infant', 'description': 'Subjects meeting inclusion criteria weighing under 40 kg', 'interventionNames': ['Other: Blood sample', 'Device: INVOS monitoring']}], 'interventions': [{'name': 'Blood sample', 'type': 'OTHER', 'description': 'During the standard of care interventional or diagnostic cardiac catheterization, paired arterial and venous blood samples will be obtained. The venous sample will be obtained from 2 cm superior to the clavicle, which is beyond standard of care during the routine cardiac catheterization', 'armGroupLabels': ['Infant', 'Pediatric']}, {'name': 'INVOS monitoring', 'type': 'DEVICE', 'description': 'During the standard of care interventional or diagnostic cardiac catheterization, INVOS monitoring will be used. INVOS™ regional oxygen saturation (rSO2) values will be compared to the calculated global field saturation of cerebral tissue determined from blood sample co-oximetry.', 'armGroupLabels': ['Infant', 'Pediatric']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Children's Mercy Kansas City", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University St. Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': "Cleveland Clinic Children's", 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Seattle Children's", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Ami R Stuart, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Principal Clinical Research Specialist'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic - MITG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}