Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-02-23 @ 1:53 PM
Study NCT ID:
NCT05987904
Status:
COMPLETED
Last Update Posted:
2024-10-30
First Post:
2023-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Study for Instant Cardiac Diagnostic and Post-operative Risk Assessment with the LynxPatch Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1097}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-28', 'studyFirstSubmitDate': '2023-07-28', 'studyFirstSubmitQcDate': '2023-08-04', 'lastUpdatePostDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Level of agreement between the LynxPatch device and echocardiography in detecting a cardiac pathology.', 'timeFrame': '30 minutes per individual', 'description': 'Comparison of the detection of the presence of a cardiac pathology by the LynxPatch device and by echocardiography-based expert diagnosis.'}], 'secondaryOutcomes': [{'measure': 'Accuracy of the LynxPatch device predictions of an adverse perioperative outcome', 'timeFrame': '30 days per individual', 'description': 'Comparison of the LynxPatch device predictions of an adverse perioperative outcome with actually occuring adverse perioperative outcome.'}, {'measure': 'Usability of the LynxPatch device', 'timeFrame': '30 minutes per individual', 'description': "Evaluation of aspects of the LynxPatch device's usability by interviewing study participants using a questionnaire."}, {'measure': 'Rate of LynxPatch-related safety incidents', 'timeFrame': '30 minutes per individual', 'description': 'Assessment of safety-related aspects with the LynxPatch device. Relevant incidents include Adverse Device Effects, Serious Adverse Device Effects and Device Defficiencies.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiac Diagnosis'], 'conditions': ['Cardiovascular Diseases', 'Heart Diseases']}, 'descriptionModule': {'briefSummary': 'In this clinical study the investigators will evaluate if it is feasible to pre-operatively identify low-risk patients, and to identify patients with cardiac pathologies with the LynxPatch.', 'detailedDescription': 'The LynxPatch is a non-invasive, wireless device for cardiac diagnosis. The aim of this study is to compare the LynxPatch predictions with the echocardiographic diagnoses of cardiac pathologies and to evaluate its perioperative risk predictions in non-cardiac surgeries. The study population includes 1100 patients that scheduled for an echocardiographic assessment or for a non-cardiac surgery. The LynxPatch measurement procedure has a duration of about 30 minutes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'In this study, all patients will be consecutively recruited that are either scheduled for an echocardiographic examination or that will be subjected to a non-cardiac surgical procedure according to their respective standard procedure.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of informed consent, i.e., the subject must be able to understand and sign the Patient Information and Consent Form.\n* Group 1: Patients that have an indication for an echocardiographic assessment.\n* Group 2: Patients that are scheduled for a non-cardiac surgery\n\nExclusion Criteria:\n\n* Subjects has implanted cardioverter defibrillator\n* Subject is pregnant\n* Subject is breastfeeding\n* Subject has compromised skin in the location where the LynxPatch is intended to be positioned'}, 'identificationModule': {'nctId': 'NCT05987904', 'acronym': 'LP-I-CARDIAG', 'briefTitle': 'Feasibility Study for Instant Cardiac Diagnostic and Post-operative Risk Assessment with the LynxPatch Device', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lynx Health Science GmbH'}, 'officialTitle': 'MDR - Feasibility Study for Instant Cardiac Diagnostic and Post-operative Risk', 'orgStudyIdInfo': {'id': 'MDR LP-I-CARDIAG'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1: Cardiologic Group', 'description': 'This group includes patients who are scheduled for echocardiography.', 'interventionNames': ['Device: LynxPatch']}, {'label': 'Group 2: Surgery Group', 'description': 'This group includes patients that are scheduled for non-cardiac surgery.', 'interventionNames': ['Device: LynxPatch']}], 'interventions': [{'name': 'LynxPatch', 'type': 'DEVICE', 'description': 'Measurements with the LynxPatch device are conducted.', 'armGroupLabels': ['Group 1: Cardiologic Group', 'Group 2: Surgery Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44789', 'city': 'Bochum', 'country': 'Germany', 'facility': 'Med. Klinik II - Kardiologie und Angiologie', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}], 'overallOfficials': [{'name': 'Aydan Ewers, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'BG Universitätsklinikum Bergmannsheil'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lynx Health Science GmbH', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Meditrial Europe Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}