Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2025-12-25 @ 5:01 PM
Study NCT ID:
NCT05490303
Status:
UNKNOWN
Last Update Posted:
2022-10-14
First Post:
2022-07-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
HeartGuide: Preliminary Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006331', 'term': 'Heart Diseases'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2023-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-13', 'studyFirstSubmitDate': '2022-07-29', 'studyFirstSubmitQcDate': '2022-08-03', 'lastUpdatePostDateStruct': {'date': '2022-10-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Probe position', 'timeFrame': 'Day 0', 'description': 'Difference between actual probe position and predicted position with guidance algorithm'}], 'secondaryOutcomes': [{'measure': 'Percentage of matches between algorithm and expert', 'timeFrame': 'Day 0'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Echocardiography', 'Guidance algorithm'], 'conditions': ['Cardiac Disease']}, 'descriptionModule': {'briefSummary': "Echocardiography is the examination of choice for the study of cardiac pathologies. Interest of echocardiography for other medical specialties has already been demonstrated (intensive care in the case of hemodynamic failure - in intra and extra hospital emergency medicine for the initial assessment of chest pain or dyspnea).\n\nThe expansion of echocardiography'use has been catalyzed by miniaturization of echographic systems and decrease in their price. Recently, probes directly connected to a tablet or phone have been developed at a limited cost.\n\nTherefore, it's possible to consider these ultrasound scanners as the new stethoscope that could be used by any health professional.\n\nThe last limit to this democratization is the training, especially for non-specialists (non-cardiologists).", 'detailedDescription': "Since January 2019, echocardiography laboratory headed by Prof. Stéphane Lafitte and DESKi (start-up - Bordeaux) have been working on guiding non-experts through their cardiac ultrasound examination.\n\nAn algorithm indicating in real time if the view obtained corresponds to a reference view has already been validated. However, this algorithm does not tell the operator which movement would improve the image quality.\n\nThanks to advances in deep learning and by combining cardiac ultrasound acquisitions with systems that record the position of the probes in real time, it would be possible to develop an algorithm able to guide the operator's movements."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients (male or female) older than 18 years,\n* Patient having a scheduled cardiac ultrasound outside any emergency context,\n* Patients who have not objected to participating in the research (at the latest on the day of inclusion and before any examination required by the research),\n* Subjects affiliated or benefiting from a social security plan,\n* Women of childbearing age who are using effective contraception.\n\nExclusion Criteria:\n\n* Person under legal protection (legal protection, guardianship or curatorship),\n* Person deprived of liberty by judicial or administrative decision,\n* Person who is unable to give his/her non-opposition,\n* Pregnant or breastfeeding women.'}, 'identificationModule': {'nctId': 'NCT05490303', 'acronym': 'HG-1', 'briefTitle': 'HeartGuide: Preliminary Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bordeaux'}, 'officialTitle': 'Development of Guidance Algorithms for Acquisition of Echocardiographic Reference Views', 'orgStudyIdInfo': {'id': 'CHUBX 2022/19'}, 'secondaryIdInfos': [{'id': '2022-A01501-42', 'type': 'OTHER', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patients', 'description': 'Patient with an echocardiography examination', 'interventionNames': ['Other: recording of the probe position']}], 'interventions': [{'name': 'recording of the probe position', 'type': 'OTHER', 'description': "For each patient, a cardiac ultrasound acquisition will be performed with an optical tracking system (infrared) recording the probe's position in real time.", 'armGroupLabels': ['Patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Stéphane LAFITTE, MD,PhD', 'role': 'CONTACT', 'email': 'stephane.lafitte@chu-bordeaux.fr', 'phone': '(0)5 57 65 64 85', 'phoneExt': '+33'}], 'facility': 'CHU de Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}], 'centralContacts': [{'name': 'Stéphane LAFITTE, MD,PhD', 'role': 'CONTACT', 'email': 'stephane.lafitte@chu-bordeaux.fr', 'phone': '(0)5 57 65 64 85', 'phoneExt': '+33'}, {'name': 'Bertrand MOAL, MD,PhD', 'role': 'CONTACT', 'email': 'bertrand.moal@deski.io', 'phone': '(0)6 63 76 08 54', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'Stéphane LAFITTE, MD,PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital, Bordeaux'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, 'collaborators': [{'name': 'DESKi', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}