Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2025-12-26 @ 5:28 PM
Study NCT ID:
NCT04684992
Status:
COMPLETED
Last Update Posted:
2021-08-24
First Post:
2020-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
GEBT Telehealth Administration Usability Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018589', 'term': 'Gastroparesis'}], 'ancestors': [{'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cwilliams@cairndx.com', 'phone': '615-376-5464', 'title': 'Chief Scientist and Compliance Officer', 'organization': 'Cairn Diagnostics'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '3 months', 'eventGroups': [{'id': 'EG000', 'title': 'GEBT Telehealth Administration Usability', 'description': 'Establish the usability of a telehealth platform for the administration of GEBT\n\nGEBT Telehealth Administration Usability: Establish the usability of a telehealth platform for the administration of GEBT', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 3, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Excessive burping and nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Severe bloating and excessive gas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting and dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Patient Ability to Prepare and Administer the 13C-Spirulina GEBT, Under the Supervision of a Telehealth Professional, According to Instructions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GEBT Telehealth Administration Usability', 'description': 'Establish the usability of a telehealth platform for the administration of GEBT\n\nGEBT Telehealth Administration Usability: Establish the usability of a telehealth platform for the administration of GEBT'}], 'classes': [{'title': 'Transfer meal to cooking cup without spilling', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}, {'title': 'Remove oxygen absorber', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}, {'title': 'Added correct amount of water', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}, {'title': 'Egg meal cooked for correct length of time', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}, {'title': 'Egg flipped middle of cooking', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}, {'title': 'Egg appeared adequately cooked', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 day', 'description': "Ability to prepare GEBT will be assessed by the telehealth administrator's observation of the patient.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Patient Ability to Prepare and Administer the 13C-Spirulina GEBT, Under the Supervision of a Telehealth Professional, According to Instructions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GEBT Telehealth Administration Usability', 'description': 'Establish the usability of a telehealth platform for the administration of GEBT\n\nGEBT Telehealth Administration Usability: Establish the usability of a telehealth platform for the administration of GEBT'}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 1 week', 'description': 'Ability to prepare GEBT will be assessed by a patient questionnaire.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Study participants assessed on a patient questionnaire whether the meal preparation instructions were clear and easy to follow.'}, {'type': 'PRIMARY', 'title': 'Patient Ability to Complete the GEBT Test Request Form, Under the Supervision of a Telehealth Professional, According to the Instructions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GEBT Telehealth Administration Usability', 'description': 'Establish the usability of a telehealth platform for the administration of GEBT\n\nGEBT Telehealth Administration Usability: Establish the usability of a telehealth platform for the administration of GEBT'}], 'classes': [{'title': 'Test Request Form returned with samples', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}, {'title': 'Patient Information Entered Correctly', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': 'Pre-meal sample times recorded', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': 'Meal start/end times recorded correctly', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}, {'title': 'Post-meal sample times recorded', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2-4 days', 'description': 'Ability to complete the GEBT test request form will be assessed by Cairn accessioning personnel upon receipt of returned breath samples.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Patient Ability to Complete the GEBT Test Request Form, Under the Supervision of a Telehealth Professional, According to the Instructions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GEBT Telehealth Administration Usability', 'description': 'Establish the usability of a telehealth platform for the administration of GEBT\n\nGEBT Telehealth Administration Usability: Establish the usability of a telehealth platform for the administration of GEBT'}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 1 week', 'description': 'Ability to complete the GEBT test request form will be assessed by a patient questionnaire.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants assessed easy of completing the GEBT test request form.'}, {'type': 'PRIMARY', 'title': 'Patient Ability to Collect GEBT Breath Samples Under the Supervision of a Telehealth Professional', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GEBT Telehealth Administration Usability', 'description': 'Establish the usability of a telehealth platform for the administration of GEBT\n\nGEBT Telehealth Administration Usability: Establish the usability of a telehealth platform for the administration of GEBT'}], 'classes': [{'title': 'Telehealth administrator observed condensate', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': 'Post meal samples collected within 5 minutes', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': 'Clinical lab personnel observed condensate', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}, {'title': 'Adequate %CO2 (>1%)', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}, {'title': 'Samples follow excretion curve shape', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}, {'title': 'Breath samples easy to collect', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 1 week', 'description': 'Ability to collect GEBT breath samples will be assessed by examination of GEBT results for participants (ensuring adequate CO2 in each sample/delta values follow expected pattern if collected in correct order).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Ability to Successfully Ship Kits/Breath Samples to/From Home', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GEBT Telehealth Administration Usability', 'description': 'Establish the usability of a telehealth platform for the administration of GEBT\n\nGEBT Telehealth Administration Usability: Establish the usability of a telehealth platform for the administration of GEBT'}], 'classes': [{'title': 'Kit arrived before test administration', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}, {'title': 'Breath samples received within 28-days', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 3 weeks', 'description': 'Ability to ship GEBT kits/breath samples to/from home will be assessed by surveying patients regarding shipping and by recording the dates that kits were shipped and received', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Ability of a Telehealth Platform to Function Correctly', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GEBT Telehealth Administration Usability', 'description': 'Establish the usability of a telehealth platform for the administration of GEBT\n\nGEBT Telehealth Administration Usability: Establish the usability of a telehealth platform for the administration of GEBT'}], 'classes': [{'title': 'No platform issues?', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}, {'title': 'No lost connection?', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}, {'title': 'No text reminder issues?', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 day', 'description': 'Verification that the software is user friendly and not subject to frequent failures during use will be assessed by a telehealth administrator questionnaire', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Ability of a Telehealth Platform to Function Correctly', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GEBT Telehealth Administration Usability', 'description': 'Establish the usability of a telehealth platform for the administration of GEBT\n\nGEBT Telehealth Administration Usability: Establish the usability of a telehealth platform for the administration of GEBT'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 3 weeks', 'description': 'Verification that the software is user friendly and not subject to frequent failures during use will be assessed by a patient questionnaire', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants assessed reliability and ease of use of telehealth platform.'}, {'type': 'PRIMARY', 'title': "Safety of Telehealth Administration of 13C-Spirulina GEBT Versus Administration in a Clinician's Facility", 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GEBT Telehealth Administration Usability', 'description': 'Establish the usability of a telehealth platform for the administration of GEBT\n\nGEBT Telehealth Administration Usability: Establish the usability of a telehealth platform for the administration of GEBT'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 3 weeks', 'description': "Any adverse events reported will be reviewed by Cairn's medical director to assess that there is no more than expected frequency of adverse events during administration of GEBT by a telehealth professional than would be expected during administration of GEBT in a clinician's facility. This will be performed by comparing the current rate of events in a physician's office versus under the supervision of a telehealth professional as identified through the risk analyses performed for GEBT administration.", 'unitOfMeasure': 'AEs associated with telehealth', 'reportingStatus': 'POSTED', 'populationDescription': 'There were no adverse events associated with telehealth administration via the telehealth procedure (e.g., burns during microwave cooking or injuries from breath collection apparatus).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'GEBT Telehealth Administration Usability', 'description': 'Establish the usability of a telehealth platform for the administration of GEBT\n\nGEBT Telehealth Administration Usability: Establish the usability of a telehealth platform for the administration of GEBT'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'GEBT Telehealth Administration Usability', 'description': 'Establish the usability of a telehealth platform for the administration of GEBT\n\nGEBT Telehealth Administration Usability: Establish the usability of a telehealth platform for the administration of GEBT'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'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.'}]}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2020-12-14', 'size': 3705650, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-12-21T12:54', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-29', 'studyFirstSubmitDate': '2020-12-08', 'resultsFirstSubmitDate': '2021-07-29', 'studyFirstSubmitQcDate': '2020-12-21', 'lastUpdatePostDateStruct': {'date': '2021-08-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-29', 'studyFirstPostDateStruct': {'date': '2020-12-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Ability to Prepare and Administer the 13C-Spirulina GEBT, Under the Supervision of a Telehealth Professional, According to Instructions', 'timeFrame': '1 day', 'description': "Ability to prepare GEBT will be assessed by the telehealth administrator's observation of the patient."}, {'measure': 'Patient Ability to Prepare and Administer the 13C-Spirulina GEBT, Under the Supervision of a Telehealth Professional, According to Instructions', 'timeFrame': 'up to 1 week', 'description': 'Ability to prepare GEBT will be assessed by a patient questionnaire.'}, {'measure': 'Patient Ability to Complete the GEBT Test Request Form, Under the Supervision of a Telehealth Professional, According to the Instructions', 'timeFrame': '2-4 days', 'description': 'Ability to complete the GEBT test request form will be assessed by Cairn accessioning personnel upon receipt of returned breath samples.'}, {'measure': 'Patient Ability to Complete the GEBT Test Request Form, Under the Supervision of a Telehealth Professional, According to the Instructions', 'timeFrame': 'up to 1 week', 'description': 'Ability to complete the GEBT test request form will be assessed by a patient questionnaire.'}, {'measure': 'Patient Ability to Collect GEBT Breath Samples Under the Supervision of a Telehealth Professional', 'timeFrame': 'up to 1 week', 'description': 'Ability to collect GEBT breath samples will be assessed by examination of GEBT results for participants (ensuring adequate CO2 in each sample/delta values follow expected pattern if collected in correct order).'}, {'measure': 'Ability to Successfully Ship Kits/Breath Samples to/From Home', 'timeFrame': 'Up to 3 weeks', 'description': 'Ability to ship GEBT kits/breath samples to/from home will be assessed by surveying patients regarding shipping and by recording the dates that kits were shipped and received'}, {'measure': 'Ability of a Telehealth Platform to Function Correctly', 'timeFrame': '1 day', 'description': 'Verification that the software is user friendly and not subject to frequent failures during use will be assessed by a telehealth administrator questionnaire'}, {'measure': 'Ability of a Telehealth Platform to Function Correctly', 'timeFrame': 'Up to 3 weeks', 'description': 'Verification that the software is user friendly and not subject to frequent failures during use will be assessed by a patient questionnaire'}, {'measure': "Safety of Telehealth Administration of 13C-Spirulina GEBT Versus Administration in a Clinician's Facility", 'timeFrame': 'Up to 3 weeks', 'description': "Any adverse events reported will be reviewed by Cairn's medical director to assess that there is no more than expected frequency of adverse events during administration of GEBT by a telehealth professional than would be expected during administration of GEBT in a clinician's facility. This will be performed by comparing the current rate of events in a physician's office versus under the supervision of a telehealth professional as identified through the risk analyses performed for GEBT administration."}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Gastroenterology', 'Gastric emptying breath test', 'Telehealth'], 'conditions': ['Gastroparesis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to establish the usability of a telehealth platform for the administration of GEBT.', 'detailedDescription': 'This study is intended to demonstrate that the 13C-Spirulina Gastric Emptying Breath Test (GEBT) can be successfully administered via a telehealth platform. Telehealth administration of GEBT is where a trained Cairn employee uses a video link to remotely supervise the completion of the test request form, collection of breath samples, cooking and consumption of the test meal and return of breath samples by the patient to Cairn.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females, greater than or equal to 18 years of age at the time of signing the consent form, from healthy and intended use population (i.e. symptomatic for gastroparesis). Women of childbearing potential must not be pregnant at the time of GEBT administration.\n* Ability to eat test meal and provide breath samples\n* Access to a microwave oven at home\n* Internet connection and telehealth accessible device (smart phone/tablet/computer with visual and voice capability) at home\n* Environment to sit comfortably and quietly at home\n\nExclusion Criteria:\n\n* History or physical exam suggestive of systemic disease such as pathophysiologic disorders such as renal failure, chronic heart disease, chronic respiratory disease, liver disease, or malabsorption syndrome\n* History of abdominal surgery except appendectomy\n* Females on hormone replacement therapy other than birth control medications\n* Receipt of any investigational drug within 4 weeks of the study\n* Pregnancy\n* Intolerance or allergy to any component of GEBT meal\n* History of neurological or psychiatric disorders'}, 'identificationModule': {'nctId': 'NCT04684992', 'briefTitle': 'GEBT Telehealth Administration Usability Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cairn Diagnostics'}, 'officialTitle': 'Telehealth Administration of 13C-Spirulina Gastric Emptying Breath Test (13C-GEBT) Usability Study', 'orgStudyIdInfo': {'id': 'PRO-CD-046'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GEBT Telehealth Administration Usability', 'description': 'Establish the usability of a telehealth platform for the administration of GEBT', 'interventionNames': ['Device: GEBT Telehealth Administration Usability']}], 'interventions': [{'name': 'GEBT Telehealth Administration Usability', 'type': 'DEVICE', 'description': 'Establish the usability of a telehealth platform for the administration of GEBT', 'armGroupLabels': ['GEBT Telehealth Administration Usability']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37027', 'city': 'Brentwood', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Cairn Diagnostics', 'geoPoint': {'lat': 36.03312, 'lon': -86.78278}}], 'overallOfficials': [{'name': 'Alex Ryder, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairn Diagnostics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairn Diagnostics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}