Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-02-24 @ 6:38 PM
Study NCT ID:
NCT01942720
Status:
COMPLETED
Last Update Posted:
2017-05-31
First Post:
2013-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Monitoring Disease Activity Using Video Capsule Endoscopy (VCE) in Crohn's Disease (CD) Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004724', 'term': 'Endoscopy'}], 'ancestors': [{'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'michal.kedar-datel@medtronic.com', 'phone': '+972-4-9097952', 'title': 'Clinical Trials Manager', 'organization': 'Medtronic'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events data collected from subject enrollment up to end of study', 'description': 'all adverse events identified on study subjects were collected from patient enrollment up to end of study duration: AE related and not related to study procedure and or product as well as anticipated and unanticipated AEs', 'eventGroups': [{'id': 'EG000', 'title': 'Capsule Endoscopy', 'description': 'Capsule endoscopy and Ileocolonoscopy tests', 'otherNumAtRisk': 74, 'otherNumAffected': 24, 'seriousNumAtRisk': 74, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Abdominal Pain', 'notes': 'non-serious AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthma', 'notes': 'non-serious AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Athralgia Of Hands And Elbows, Arthritis Flare', 'notes': 'non-serious AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'back pain', 'notes': 'non-serious AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bilateral Bursitis In Hips', 'notes': 'non-serious AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Blolating', 'notes': 'non-serious AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bruise At Venipucture Site. Right Anticubital Space', 'notes': 'non-serious AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bruised Coccyx Due To Fall', 'notes': 'non-serious AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'C-Difficile', 'notes': 'non-serious AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest Pain', 'notes': 'non-serious ae', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Common Cold, cough', 'notes': 'non-serious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': "Crohn's Flare", 'notes': 'non-serious AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cyst Right Great Toe', 'notes': 'non-serious AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Detached Retina', 'notes': 'non-serious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'notes': 'non-serious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'notes': 'non-serious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'fell', 'notes': 'non-serious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Flu', 'notes': 'non-serious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Heartburn', 'notes': 'non-serious AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyponatremia', 'notes': 'non-serious AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Incontinence a Little Worse And More Often', 'notes': 'non-serious AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Iron Deficiency Anemia', 'notes': 'non-serious AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Joint pain', 'notes': 'non-serious AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Light Headed', 'notes': 'non-serious AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Mild Perianal Erythema', 'notes': 'non-serious AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal congestion', 'notes': 'non-serious AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'notes': 'non-serious AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulled Upper Back Muscle Left Side', 'notes': 'non-serious AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Questionable Right Lower Quadrant Mass', 'notes': 'non-serious AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'notes': 'non-serious AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rectal Urgency', 'notes': 'non-serious AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory infection', 'notes': 'non-serious AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Right Leg Bruising Secondary To Fall', 'notes': 'non-serious AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Strep Throat', 'notes': 'non-serious AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Superficial Blood Clot Left Axilla Area', 'notes': 'non-serious AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'notes': 'non-serious AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'notes': 'non-serious AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Worsening Diabetes', 'notes': 'non-serious AE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Worsening of IBD, Nausea, vomiting, diarrhea, abdominal pain', 'notes': 'Unanticipated serious adverse event not related to study device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthma Excerbation, Shortness of Breath', 'notes': 'Unanticipated serious adverse event not related to study device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pancreatitis, Acute', 'notes': 'Unanticipated serious adverse event not related to study device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mucosal Change in VCE (Video Capsule Endoscopy) Mucosal Scores and PGA (Physician Global Assessment)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Capsule Endoscopy', 'description': 'Capsule endoscopy and Ileocolonoscopy tests'}], 'classes': [{'title': 'PGA score change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.77', 'groupId': 'OG000'}]}]}, {'title': 'Total SB Lewis score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-382.9', 'spread': '1232.8', 'groupId': 'OG000'}]}]}, {'title': 'Total SB CECDEIS score change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.7', 'spread': '9.05', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.631', 'groupIds': ['OG000'], 'paramType': 'Sperman correlation coeficient', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.70', 'groupDescription': 'Relationship of total PillCam SB Lewis score with PGA score change from baseline visit to 6 month follow-up', 'statisticalMethod': 'Sperman test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.882', 'groupIds': ['OG000'], 'paramType': 'Sperman correlation coeficient', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.022', 'groupDescription': 'Relationship of total PillCam SB CECDEIS score with PGA score change from baseline visit to 6 month follow-up', 'statisticalMethod': 'Sperman correlation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '6 months changefrom Baseline', 'description': 'To correlate the mucosal change in VCE mucosal score (Lewis score and CECDEIS( Capsule Endoscopy Crohn\'s Disease Endoscopic Index)) with change in Physician Global Assessment of CD activity 6 months after the first VCE procedure; PGA scale: 0-Normal, 1-Mild disease, 2- Moderate Disease, 3-Severe Disease Lewis Score scale: continuance scale variable, higher score higher disease severity (0- unlimited) remission \\<135 CECDEIS score scale: continuance scale variable, higher score higher disease severity (0-44) , no "normal range" Studies discuss a drop in the number as indicating healing but not a specific cutoff', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Correlation between changes in VCE mucosal scores (Lewis and CECDEIS) and change in PGA score of CD (Crohn's Disease) activity from baseline to follow-up at 6 months; number of participants for this outcome measure includes participants with available data for PGA, SB (small bowel) Lewis score, SB CECDEIS score, respectively"}, {'type': 'SECONDARY', 'title': "Correlation Between SES CD (Simple Endoscopic Score for Chron's Disease) Score and Capsule Scoring Indexes", 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Capsule Endoscopy', 'description': 'Capsule endoscopy and Ileocolonoscopy tests'}], 'classes': [{'title': 'TI SES-CD score at baseline visit', 'categories': [{'measurements': [{'value': '3.2', 'spread': '3.62', 'groupId': 'OG000'}]}]}, {'title': 'TI Lewis score at baseline', 'categories': [{'measurements': [{'value': '11941.1', 'spread': '1874.7', 'groupId': 'OG000'}]}]}, {'title': 'TI CECDEIS score at baseline', 'categories': [{'measurements': [{'value': '14', 'spread': '15.51', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'Sperman correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.735', 'groupDescription': 'Relationship of PillCam SB TI Lewis scores with TI SES-CD score at baseline visit', 'statisticalMethod': 'Sperman correlation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'Sperman correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.726', 'groupDescription': 'Relationship of PillCam SB TI CECDEIS scores with TI SES-CD score at baseline visit', 'statisticalMethod': 'Sperman correlation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Evaluate the correlation between SES CD score and capsule scoring indexes (Lewis and CECDEIS) in the TI (Terminal Ileum) at baseline.\n\nSES CD score scale 0-12, Higher score=higher disease severity Lewis Score scale: continuance scale variable, higher score higher disease severity (0- unlimited) remission \\<135 CECDEIS score scale: continuance scale variable, higher score higher disease severity (0-44) , no "normal range" Studies discuss a drop in the number as indicating healing but not a specific', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'number of participants for this outcome measure includes participants with available data for SES CD, TI Lewis score, TI CECDEIS score, respectively'}, {'type': 'SECONDARY', 'title': 'Correlation Between the Change in SES CD Score and the Change in Capsule Scoring Indexes- in Terminal Ileum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Capsule Endoscopy', 'description': 'Capsule endoscopy and Ileocolonoscopy tests'}], 'classes': [{'title': 'TI SES-CD score change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '2.88', 'groupId': 'OG000'}]}]}, {'title': 'TI Lewis score change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-410.8', 'spread': '1266.9', 'groupId': 'OG000'}]}]}, {'title': 'TI CECDEIS score change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.1', 'spread': '11.55', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000'], 'paramType': 'Sperman correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.493', 'groupDescription': 'Relationship of PillCam SB Lewis score with TI SES-CD score change from baseline visit to 6 month follow-up', 'statisticalMethod': 'Sperman correlation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'Sperman correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.531', 'groupDescription': 'Relationship of PillCam SB CECDEIS score with TI SES-CD score change from baseline visit to 6 month follow-up', 'statisticalMethod': 'Sperman correlation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '6 months change from Baseline', 'description': 'Evaluate the correlation between the change in SES CD score and the change in capsule scoring indexes (Lewis and CECDEIS) in the TI after 6 months SES CD score scale 0-12, Higher score=higher disease severity Lewis Score scale: continuance scale variable, higher score higher disease severity (0- unlimited) remission \\<135 CECDEIS score scale: continuance scale variable, higher score higher disease severity (0-44) , no "normal range" Studies discuss a drop in the number as indicating healing but not a specific cutoff', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'number of subjects with Colonoscopy score is lower than number of subjects analyzed due to colonoscopy video malfunction. number of participants for this outcome measure includes participants with available data for TI SES CD, TI Lewis, TI CECDEIS scores, respectively'}, {'type': 'SECONDARY', 'title': 'Evaluate the Entire SB CE Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Capsule Endoscopy', 'description': 'Capsule endoscopy and Ileocolonoscopy tests'}], 'classes': [{'title': 'total SB Lewis score change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-382.9', 'spread': '1232.8', 'groupId': 'OG000'}]}]}, {'title': 'TI Lewis score change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-410.8', 'spread': '1266.9', 'groupId': 'OG000'}]}]}, {'title': 'Total SB CECDEIS score change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.7', 'spread': '9.05', 'groupId': 'OG000'}]}]}, {'title': 'TI CECDEIS score change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.1', 'spread': '11.55', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'Sperman correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.752', 'groupDescription': 'Relationship of PillCam total SB Lewis score change with TI Leis score change from baseline visit to 6 month follow-up', 'statisticalMethod': 'Sperman correlation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'Sperman correlation coefficient', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.785', 'groupDescription': 'Relationship of PillCam total SB CECDEIS score change with TI Leis score change from baseline visit to 6 month follow-up', 'statisticalMethod': 'Sperman correlation', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '6 months change from Baseline', 'description': 'Evaluate the entire SB CE Scores (Lewis \\& CECDEIS) change as compared to the change at TI in CE Scores (Lewis \\& CECDEIS).\n\nLewis Score scale: continuance scale variable, higher score higher disease severity (0- unlimited) remission \\<135 CECDEIS score scale: continuance scale variable, higher score higher disease severity (0-44) , no "normal range" Studies discuss a drop in the number as indicating healing but not a specific', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'number of Lewis \\& CECDEIS TI score change is lower due to inability to identify TI. number of participants for this outcome measure includes participants with available data for total SB Lewis score change, TI Lewis score change, Total CECDEIS score change, TI Lewis score change, respectively'}, {'type': 'SECONDARY', 'title': 'Adverse Events (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Capsule Endoscopy', 'description': 'Capsule endoscopy and Ileocolonoscopy tests'}], 'classes': [{'title': 'Incidence of Serious Adverse Events', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Incidence of Non-Serious Adverse Events', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}]}]}, {'title': 'Incidence of Anticipated Adverse Events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Incident of Serious Unanticipated Adverse Events', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'To assess safety related to capsule retention and other adverse events', 'unitOfMeasure': 'AE incidents', 'reportingStatus': 'POSTED', 'populationDescription': 'all enrolled subjects'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Capsule Endoscopy', 'description': 'Capsule endoscopy and Ileocolonoscopy tests'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}]}], 'recruitmentDetails': 'recruitment started on September 2013 and ended on July 2016 74 subjects enrolled within 15 sites in the US'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Capsule Endoscopy', 'description': 'Capsule endoscopy and Ileocolonoscopy tests'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '68', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.3', 'spread': '13.92', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '44', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '74', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-30', 'studyFirstSubmitDate': '2013-09-11', 'resultsFirstSubmitDate': '2016-12-22', 'studyFirstSubmitQcDate': '2013-09-11', 'lastUpdatePostDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-30', 'studyFirstPostDateStruct': {'date': '2013-09-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mucosal Change in VCE (Video Capsule Endoscopy) Mucosal Scores and PGA (Physician Global Assessment)', 'timeFrame': '6 months changefrom Baseline', 'description': 'To correlate the mucosal change in VCE mucosal score (Lewis score and CECDEIS( Capsule Endoscopy Crohn\'s Disease Endoscopic Index)) with change in Physician Global Assessment of CD activity 6 months after the first VCE procedure; PGA scale: 0-Normal, 1-Mild disease, 2- Moderate Disease, 3-Severe Disease Lewis Score scale: continuance scale variable, higher score higher disease severity (0- unlimited) remission \\<135 CECDEIS score scale: continuance scale variable, higher score higher disease severity (0-44) , no "normal range" Studies discuss a drop in the number as indicating healing but not a specific cutoff'}], 'secondaryOutcomes': [{'measure': "Correlation Between SES CD (Simple Endoscopic Score for Chron's Disease) Score and Capsule Scoring Indexes", 'timeFrame': 'Baseline', 'description': 'Evaluate the correlation between SES CD score and capsule scoring indexes (Lewis and CECDEIS) in the TI (Terminal Ileum) at baseline.\n\nSES CD score scale 0-12, Higher score=higher disease severity Lewis Score scale: continuance scale variable, higher score higher disease severity (0- unlimited) remission \\<135 CECDEIS score scale: continuance scale variable, higher score higher disease severity (0-44) , no "normal range" Studies discuss a drop in the number as indicating healing but not a specific'}, {'measure': 'Correlation Between the Change in SES CD Score and the Change in Capsule Scoring Indexes- in Terminal Ileum', 'timeFrame': '6 months change from Baseline', 'description': 'Evaluate the correlation between the change in SES CD score and the change in capsule scoring indexes (Lewis and CECDEIS) in the TI after 6 months SES CD score scale 0-12, Higher score=higher disease severity Lewis Score scale: continuance scale variable, higher score higher disease severity (0- unlimited) remission \\<135 CECDEIS score scale: continuance scale variable, higher score higher disease severity (0-44) , no "normal range" Studies discuss a drop in the number as indicating healing but not a specific cutoff'}, {'measure': 'Evaluate the Entire SB CE Scores', 'timeFrame': '6 months change from Baseline', 'description': 'Evaluate the entire SB CE Scores (Lewis \\& CECDEIS) change as compared to the change at TI in CE Scores (Lewis \\& CECDEIS).\n\nLewis Score scale: continuance scale variable, higher score higher disease severity (0- unlimited) remission \\<135 CECDEIS score scale: continuance scale variable, higher score higher disease severity (0-44) , no "normal range" Studies discuss a drop in the number as indicating healing but not a specific'}, {'measure': 'Adverse Events (AE)', 'timeFrame': '6 months', 'description': 'To assess safety related to capsule retention and other adverse events'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Known Crohn Disease Subjects']}, 'referencesModule': {'references': [{'pmid': '30086261', 'type': 'DERIVED', 'citation': "Melmed GY, Dubinsky MC, Rubin DT, Fleisher M, Pasha SF, Sakuraba A, Tiongco F, Shafran I, Fernandez-Urien I, Rosa B, Papageorgiou NP, Leighton JA. Utility of video capsule endoscopy for longitudinal monitoring of Crohn's disease activity in the small bowel: a prospective study. Gastrointest Endosc. 2018 Dec;88(6):947-955.e2. doi: 10.1016/j.gie.2018.07.035. Epub 2018 Aug 4."}]}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate the performance of VCE in the assessment of mucosal inflammation 6 months after the first VCE procedure', 'detailedDescription': "This is a prospective, multi-center (up to 15 sites) study which aims to assess the ability of VCE (Video capsule endoscopy) to detect change in the severity of the small bowel mucosal disease activity in CD subjects after 6 months .\n\nUp to 75 subjects will participate in this study. An interim analysis will be done after study completion with 20 subjects. All subjects to be enrolled in this study will be pediatric and\\\\or adult subjects with known Crohn's disease"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject ages 2-75 years, inclusive\n2. Subjects with a diagnosis of known Crohn disease\n3. Referred to ileocolonoscopy (up to 4 weeks before the CE procedure)\n4. Proven patency by the Agile capsule or another approach deemed clinically acceptable by the investigator, e.g. CT enterography, MRE (Magenetic Resonance Enteroscopy), performed within the 90 days prior to enrollment.\n5. Subject or parent agrees to sign consent form\n\nExclusion Criteria:\n\nThe presence of any of the following will exclude a subject from study enrollment:\n\n1. Subjects with change in IBD (Inflammatory Bowel Disease) drug therapy between the baseline ileocolonoscopy and VCE\n2. Subjects with a history of prior ileocecectomy, Ileal Pouch-Anal Anastomosis (IPAA) and J pouch or an ostomy\n3. Stricture seen on radiological exam.\n4. Indeterminate Colitis\n5. Ulcerative Colitis\n6. Antibiotic Associated Colitis\n7. Known history of intestinal obstruction or current obstructive symptoms, such as severe abdominal pain with accompanying nausea or vomiting, based on investigator judgment.\n8. Non-steroidal anti-inflammatory drugs including aspirin (twice weekly or more), not including aspirin up to 81mg daily, during the 4 weeks preceding enrollment\n9. Suspected GI stricture, followed by PillCam® Patency study or other imaging study that could not prove patency of the GI tract.\n10. Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.\n11. Subjects with known or suspected delayed gastric emptying\n12. Subjects with known or suspected delayed Small bowel motility\n13. Subject has any allergy or other known contraindication to the medications used in the study.\n14. Women who are either pregnant or nursing at the time of screening, or are of child-bearing potential and do not agree to practice medically acceptable methods of contraception.\n15. Unwillingness to use a medically accepted method of contraception throughout duration of study\n16. Concurrent participation in another clinical trial using any investigational drug or device.\n17. Subject has cardiac pacemaker or other implanted electromedical devices\n18. Subject suffers from a life threatening condition.\n19. Subject with a history or clinical evidence of renal disease and/or previous clinically significant laboratory abnormalities of renal function parameters.\n20. Subject suffers from any condition, such as swallowing problems, which precludes compliance with study and/or device instructions.'}, 'identificationModule': {'nctId': 'NCT01942720', 'briefTitle': "Monitoring Disease Activity Using Video Capsule Endoscopy (VCE) in Crohn's Disease (CD) Subjects", 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic - MITG'}, 'officialTitle': "Monitoring Disease Activity Using Video Capsule Endoscopy (VCE) in Crohn's Disease (CD) Subjects", 'orgStudyIdInfo': {'id': 'MA-209'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Capsule endoscopy', 'interventionNames': ['Device: Capsule endoscopy and Ileocolonoscopy tests']}], 'interventions': [{'name': 'Capsule endoscopy and Ileocolonoscopy tests', 'type': 'DEVICE', 'armGroupLabels': ['Capsule endoscopy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Borland-Groover Clinic', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'city': 'Winter Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Shafran Gastroenterology Center', 'geoPoint': {'lat': 28.6, 'lon': -81.33924}}, {'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Children's Center for Digestive Healthcare", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'The University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana Unveresity Hospital', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'city': 'Clive', 'state': 'Iowa', 'country': 'United States', 'facility': 'Iowa Digestive Disease Center', 'geoPoint': {'lat': 41.60304, 'lon': -93.72411}}, {'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'city': 'Chevy Chase', 'state': 'Maryland', 'country': 'United States', 'facility': 'Metropolitan Gastroenterology Group', 'geoPoint': {'lat': 39.00287, 'lon': -77.07115}}, {'city': 'Michigan', 'state': 'Michigan', 'country': 'United States', 'facility': 'Digestive Health Center of Michigan'}, {'city': 'Morristown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Atlantic Health System Morristown Memorial Pediatric GE', 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}, {'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'UNC Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '45440', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Dr. Romeo, Dayton Gastroenterology', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'city': 'Chesapeake', 'state': 'Virginia', 'country': 'United States', 'facility': 'Gastroenterology Associates of Tidewater', 'geoPoint': {'lat': 36.81904, 'lon': -76.27494}}], 'overallOfficials': [{'name': 'Jonathan Leighton, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}, {'name': 'Gil Melmed, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cyder Cinai LA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic - MITG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}