Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:30 PM
Study NCT ID:
NCT05778851
Status:
COMPLETED
Last Update Posted:
2025-10-30
First Post:
2023-03-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Clinical Utility of a Non Endoscopic Device EsoCheck and Biomarker EsoGuard as Alternative to Endoscopy for Screening for Barrett's Esophagus in At Risk Population
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-09-26', 'type': 'ESTIMATED'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001471', 'term': 'Barrett Esophagus'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'VTL@PAVmed.com', 'phone': '425.218.6535', 'title': 'Victoria T. Lee, MD CMO, SVM Clinical Affairs', 'organization': 'PAVmed Inc., Lucid Diagnostics Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed.', 'description': 'All-Cause Mortality, Serious, and Other \\[Not Including Serious\\] Adverse Events were not monitored/assessed.', 'eventGroups': [{'id': 'EG000', 'title': 'Participants', 'description': 'Physician providers who completed online questionnaires', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "The Impact of EsoCheck/EsoGuard on Provider's Decision for Upper Endoscopy Referral", 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}, {'units': 'Cases', 'counts': [{'value': '540', 'groupId': 'OG000'}, {'value': '522', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Cases', 'description': 'Virtual patient cases without EsoGuard results'}, {'id': 'OG001', 'title': 'Intervention Cases', 'description': 'Virtual patient cases with EsoGuard results'}], 'classes': [{'categories': [{'measurements': [{'value': '382', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month', 'description': 'The change in the percentage/rate of intervention cases who will be referred for endoscopy compared to the control cases.', 'unitOfMeasure': 'Cases', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Cases', 'denomUnitsSelected': 'Cases', 'populationDescription': 'A total of 540 control cases were reviewed by 90 providers, and a total of 522 intervention cases were reviewed by 87 providers.'}, {'type': 'SECONDARY', 'title': "The Impact of EsoCheck/EsoGuard on Provider's Decision for Upper Endoscopy Referral for EsoGuard Positive Cases", 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}, {'units': 'Cases', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Cases', 'description': 'Virtual patient cases without EsoGuard results'}, {'id': 'OG001', 'title': 'Intervention Cases', 'description': 'Virtual patient cases with EsoGuard results'}], 'classes': [{'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month', 'description': 'The change in the percentage/rate of EsoGuard postive intervention cases who will be referred for endoscopy compared to the control cases.', 'unitOfMeasure': 'Cases', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Cases', 'denomUnitsSelected': 'Cases', 'populationDescription': 'A total of 90 EsoGuard + control cases were reviewed by 90 providers, and a total of 87 EsoGuard + intervention cases were reviewed by 87 providers.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Participating Physicians', 'description': 'Each participating physician completed 2 times a questionnaire with 6 virtual patient cases per provider with GERD, BE risk factors and without an EsoGuard result and with an EsoGuard result. With 90 participants the total in the control group is 540 control cases, and 87 participants completed the second questionnaire leading to 522 intervention cases.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '540', 'numSubjects': '90'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '522', 'numSubjects': '87'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '18', 'numSubjects': '3'}]}]}], 'typeUnitsAnalyzed': 'Cases', 'recruitmentDetails': '97 physicians (participant providers) signed an ICF.', 'preAssignmentDetails': 'A total of 90 providers completed the control round questionnaire with 6 control cases (total of 540 control cases) and a total of 87 completed the intervention round questionnaire with 6 cases (total of 522 intervention cases).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Participating Physicians', 'description': 'Participating physicians could be primary care physicians or specialists.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '90', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female'}, {'title': 'Male'}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data not collected'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Physician type', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Primary Care', 'measurements': [{'value': '68', 'groupId': 'BG000'}]}, {'title': 'Specialist', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'populationDescription': 'Primary Care'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-03-06', 'size': 408132, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-10-01T11:49', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-21', 'studyFirstSubmitDate': '2023-03-10', 'resultsFirstSubmitDate': '2025-09-04', 'studyFirstSubmitQcDate': '2023-03-10', 'lastUpdatePostDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-10-21', 'studyFirstPostDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "The Impact of EsoCheck/EsoGuard on Provider's Decision for Upper Endoscopy Referral", 'timeFrame': '1 month', 'description': 'The change in the percentage/rate of intervention cases who will be referred for endoscopy compared to the control cases.'}], 'secondaryOutcomes': [{'measure': "The Impact of EsoCheck/EsoGuard on Provider's Decision for Upper Endoscopy Referral for EsoGuard Positive Cases", 'timeFrame': '1 month', 'description': 'The change in the percentage/rate of EsoGuard postive intervention cases who will be referred for endoscopy compared to the control cases.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Barrett Esophagus']}, 'descriptionModule': {'briefSummary': "This will be a prospective randomized, controlled, virtual, patient study to measure the impact of EsoCheck/EsoGuard on health care provider's decision for upper endoscopy referral.\n\nThe participants will complete two rounds of questions concerning the assessed risk for BE and decision for endoscopy referral of 6 patient cases (clinical vignettes).\n\nAfter the first round has been completed, an EsoCheck/EsoGuard educational information package and the second round of 6 clinical vignettes including EsoGuard results will be sent.", 'detailedDescription': "This will be a prospective randomized, controlled, virtual, patient study to measure the impact of EsoCheck/EsoGuard on health care provider's decision for upper endoscopy referral.\n\nAround 200 US physicians will be asked to participate in this study and at least 100 will be enrolled. Physicians eligible for participation are those whose scope of practice includes preventative care and disease screening - namely screening of BE, such as primary care physicians, family medicine physicians, and general practitioners; physicians whose scope of practice include diagnosis and management of esophageal disease may also participate.\n\nThe participants will complete two rounds of questions concerning the assessed risk for BE and decision for endoscopy referral of 6 patient cases (clinical vignettes). Per round, there will be 3 different questionnaires consisting of 6 clinical vignettes (A/B/C). Participants will be randomized to questionnaire A, B or C according to the randomization scheme. After the first round has been completed, an EsoCheck/EsoGuard educational information package and the second round of 6 clinical vignettes including EsoGuard results will be sent."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Board-certified physicians whose scope of practice includes preventative care and disease screening, and/or those whose scope of practice include diagnosis and management of esophageal disease (examples include but are not limited to primary care physicians/ general practitioners, family medicine physicians, gastroenterologists, and foregut surgeons);\n2. Have between 1 to 40 years of post-residency clinical experience within their field of practice;\n3. Have an active panel (whether as part of a group practice, or individually) of over 1000 patients with an adult patient load of more than 50%.\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT05778851', 'acronym': 'ASBE', 'briefTitle': "Clinical Utility of a Non Endoscopic Device EsoCheck and Biomarker EsoGuard as Alternative to Endoscopy for Screening for Barrett's Esophagus in At Risk Population", 'organization': {'class': 'INDUSTRY', 'fullName': 'Lucid Diagnostics, Inc.'}, 'officialTitle': "Clinical Utility of a Non Endoscopic Device EsoCheck and Biomarker EsoGuard as Alternative to Endoscopy for Screening for Barrett's Esophagus in At Risk Population (ASBE) A Randomized Controlled, Virtual Patient Trial", 'orgStudyIdInfo': {'id': 'ASBE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Virtual patient cases with GERD and similar BE risk factors as the cases in intervention but without an EsoGuard result and in a different order.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention', 'description': 'Virtual patient cases with GERD and similar BE risk factors as the cases in the control arm with an EsoGuard result.', 'interventionNames': ['Device: EsoGuard result']}], 'interventions': [{'name': 'EsoGuard result', 'type': 'DEVICE', 'description': 'Education slide-set EsoGuard and patient cases including EsoGuard result', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10017', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Lucid Diagnostics', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Victoria T Lee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lucid Diagnostics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lucid Diagnostics, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Medex15', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}