Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2026-02-22 @ 10:16 AM
Study NCT ID:
NCT01439035
Status:
COMPLETED
Last Update Posted:
2019-04-03
First Post:
2011-09-20
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluate the Use of Optical Frequency Domain Imaging (OFDI) for Celiac Disease in Children, Adolescents and Young Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002446', 'term': 'Celiac Disease'}], 'ancestors': [{'id': 'D008286', 'term': 'Malabsorption Syndromes'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gtearney@partners.org', 'phone': '617-724-2979', 'title': 'Dr. Gary Tearney PI', 'organization': 'Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'The duration of the imaging procedure', 'description': 'No adverse evens has been reported', 'eventGroups': [{'id': 'EG000', 'title': 'MGH OFDI Imaging', 'description': 'OFDI imaging\n\nMGH OFDI Imaging: Imaging of Duodenum with OFDI system', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects With Changes of Villous Architecture Undergoing OFDI Imaging', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Compare OFDI Images to Histologic', 'description': 'compare OFDI images to histologic evaluation in children, adolescents and young adults with suspected Celiac disease'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'during imaging session', 'description': 'OFDI images analyzed and compared to standard of care biopsies to identify celiac disease caracteristic mucosal lesions.\n\nIn this pilot study, we demonstrated the feasibility of using OFDI for visualizing changes of villous architecture in CD patients in vivo', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects 7 or over 7 years old with Celiac Disease'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MGH OFDI Imaging', 'description': 'OFDI imaging\n\nMGH OFDI Imaging: Imaging of Duodenum with OFDI system'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'MGH OFDI Imaging', 'description': 'OFDI imaging\n\nMGH OFDI Imaging: Imaging of Duodenum with OFDI system'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Six subjects completed this study', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '16.3', 'spread': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2011-02-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-01', 'studyFirstSubmitDate': '2011-09-20', 'resultsFirstSubmitDate': '2018-07-23', 'studyFirstSubmitQcDate': '2011-09-21', 'lastUpdatePostDateStruct': {'date': '2019-04-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-27', 'studyFirstPostDateStruct': {'date': '2011-09-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-02-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects With Changes of Villous Architecture Undergoing OFDI Imaging', 'timeFrame': 'during imaging session', 'description': 'OFDI images analyzed and compared to standard of care biopsies to identify celiac disease caracteristic mucosal lesions.\n\nIn this pilot study, we demonstrated the feasibility of using OFDI for visualizing changes of villous architecture in CD patients in vivo'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Celiac Disease', 'Duodenal', 'OCT', 'Imaging'], 'conditions': ['Celiac Disease']}, 'descriptionModule': {'briefSummary': 'The goal of this research is to conduct a pilot clinical study to image Celiac disease characteristic mucosal lesions and compare Optical Frequency Domain Imaging (OFDI) images to histologic evaluation in children, adolescents and young adults with suspected Celiac disease.', 'detailedDescription': 'The Optical Frequency Domain Imaging(OFDI) catheter will be used in conjunction with a standard pediatric endoscope. The endoscopist will introduce the OFDI imaging catheter through the biopsy channel of the endoscope already in place. The catheter will be passed into the view of the endoscope so that the tip of the catheter can be directly visualized throughout the procedure. The catheter will be placed adjacent to the bowel wall in the vicinity of the target locations. Once the OFDI probe is in place, OFDI imaging will start and data will be continuously collected during helical pullback scanning of the inner catheter drive shaft over a predetermined length of approximately 3 cm.\n\nIt is expected that the total experimental procedure including the insertion of the OFDI catheter, OFDI imaging, and removal of the catheter will add approximately 10 minutes to the total length of the procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 7 years and above undergoing upper endoscopy for evaluation of celiac disease\n* Clinical history, physical findings, family history, or serologic evaluation suggestive of celiac disease\n* Parents/guardian available to sign informed consent\n\nExclusion Criteria:\n\n* Patients with a history of hemostasis disorders\n* Use of Nonsteroidal anti-inflammatory drugs(NSAIDS) within ten days preceding initiation of the study\n* Use of any oral anticoagulation medication within one month preceding initiation of the study\n* Any known blood coagulation disorder'}, 'identificationModule': {'nctId': 'NCT01439035', 'briefTitle': 'Evaluate the Use of Optical Frequency Domain Imaging (OFDI) for Celiac Disease in Children, Adolescents and Young Adults', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Pilot Study to Evaluate Use of Optical Frequency Domain Imaging (OFDI) for Duodenal Imaging in Celiac Disease in Children, Adolescents and Young Adults', 'orgStudyIdInfo': {'id': '2009-P-000938'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MGH OFDI imaging', 'description': 'OFDI imaging', 'interventionNames': ['Device: MGH OFDI Imaging']}], 'interventions': [{'name': 'MGH OFDI Imaging', 'type': 'DEVICE', 'description': 'Imaging of Duodenum with OFDI system', 'armGroupLabels': ['MGH OFDI imaging']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Guillermo Tearney, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}, {'name': 'Aubrey Katz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Pathology', 'investigatorFullName': 'Guillermo Tearney', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}