Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2025-12-29 @ 9:20 PM
Study NCT ID:
NCT03241368
Status:
COMPLETED
Last Update Posted:
2020-06-09
First Post:
2017-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Study Comparing PillCam® Crohn's Capsule Endoscopy to Ileocolonoscopy (IC) Plus MRE for Detection of Active CD in the Small Bowel and Colon in Subjects With Known CD and Mucosal Disease.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-05-28', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D053704', 'term': 'Capsule Endoscopy'}], 'ancestors': [{'id': 'D016099', 'term': 'Endoscopy, Gastrointestinal'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'amanda.m.wenisch@medtronic.com', 'phone': '1-206-225-4025', 'title': 'Amanda Wenisch, Clinical Resaerch Coordinator / Study Manager', 'organization': 'Medtronic GIH'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 weeks plus 30 days - Events will be collected for all enrolled subjects with the start of baseline imaging procedures (MRE) and end 14 days following completion of the IC procedure. Subjects with Adverse Event (AE) 14 days following the IC procedure will be followed for 30 days or until event resolves, whichever comes first.', 'eventGroups': [{'id': 'EG000', 'title': 'MRE, Patency Capsule (if Needed), CE, and IC', 'description': "Single-arm study, which includes MRE procedure, Patency Capsule Procedure (if needed), PillCam Crohn's Capsule Endoscopy Procedure and Ileocolonoscopy procedure.\n\nCapsule Endoscopy: At baseline subject will under the PillCam Crohn's Capsule Procedure", 'otherNumAtRisk': 119, 'deathsNumAtRisk': 119, 'otherNumAffected': 11, 'seriousNumAtRisk': 119, 'deathsNumAffected': 0, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ISO 14155:2011'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ISO 14155:2011'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ISO 14155:2011'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ISO 14155:2011'}, {'term': 'Infusion site extravasation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ISO 14155:2011'}, {'term': 'Oesophageal candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ISO 14155:2011'}, {'term': 'Staphylococcal skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ISO 14155:2011'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ISO 14155:2011'}, {'term': 'Post procedural complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ISO 14155:2011'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ISO 14155:2011'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ISO 14155:2011'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ISO 14155:2011'}, {'term': 'Emotional distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ISO 14155:2011'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ISO 14155:2011'}], 'seriousEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ISO 14155:2011'}, {'term': "Crohn's Disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ISO 14155:2011'}, {'term': 'Complication of device removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ISO 14155:2011'}, {'term': 'Clostridium difficile infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ISO 14155:2011'}, {'term': 'Serum sickness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ISO 14155:2011'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Accuracy of CE Versus IC Plus MRE for Detecting Active Crohn's Disease (CD), by Visualizing the Small Bowel and Colon in Subjects With Know CD and Mucosal Disease.", 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MRE, Patency Capsule (if Needed), CE, and IC', 'description': "Subjects will undergo MRE, patency capsule (if necessary), CE, and IC procedures.\n\nIf MRE shows evidence of a stricture, subject must undergo a Patency procedure prior to CE. If patency cannot be confirmed through MRE or patency capsule will be discontinued from the study.\n\nSubjects will perform bowel preparation and follow a detailed dietary regimen for CE and IC procedures. Between 45 and 75 minutes after final PEG ingestion, subject will swallow the PillCam Crohn's Capsule. Adequate boosts will be administered, as necessary. Subjects will be allowed to leave clinic after 'Alert 2' is received and if capsule is not yet excreted. Subjects leaving prior to excretion will be instructed to disconnect the recorder at excretion or battery failure (whichever is first).\n\nAfter CE procedure (either same or following day), subject will undergo IC. If the IC is done the following day, subject will stay on clear liquid diet (or NPO, per physician's discretion for sedation)."}], 'classes': [{'title': 'Sensitivity CE Overall', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000', 'lowerLimit': '86', 'upperLimit': '98'}]}]}, {'title': 'Sensitivity MRE + IC Overall', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '95', 'upperLimit': '100'}]}]}, {'title': 'Specificity CE Overall', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000', 'lowerLimit': '55', 'upperLimit': '87'}]}]}, {'title': 'Specificity MRE + IC Overall', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '41'}]}]}], 'analyses': [{'pValue': '0.125', 'groupIds': ['OG000'], 'groupDescription': 'This was a 1-arm, non-powered study. Sensitivity, Specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) was estimated for each treatment group, along with the 95% confidence interval. The difference between treatment groups in Sensitivity and Specificity was compared.', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'OTHER', 'statisticalComment': "Exact McNemar's test", 'nonInferiorityComment': "Comparative - This purpose of this study is to evaluate performance of the PillCam Crohn's capsule \\[referred to as capsule endoscopy (CE)\\] as compared to IC with MRE."}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': "Central readers will be used to read all videos/images and analyses will be based on these results. A consensus panel will be used if there are discrepancies in results between modalities at baseline. Capsule endoscopy and IC results will be read by gastroenterologists and MRE results will be read by radiologists.\n\nScores used will be Lewis Score, Simple Endoscopic Score for Crohn's Disease Index (SES-CD) Score and Magnetic Resonance Index of Activity (MaRIA) Score", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol analysis set, includes subjects who underwent MRE, CE, and IC (and could be evaluated for CD activity) who had no major deviations (violations that may have significant impact on outcomes) and did not meet following criteria:\n\n* Subject withdraws\n* Capsule remained in stomach or small bowel for entire procedure\n* Technical failure'}, {'type': 'SECONDARY', 'title': 'Specificity, Negative Predictive Value, and Positive Predictive Value for Active CD in the Small Bowel and Colon by CE as Compared to IC Plus MRE.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MRE, Patency Capsule (if Needed), CE, and IC', 'description': "Subjects will undergo MRE, patency capsule (if necessary), CE, and IC procedures.\n\nIf MRE shows evidence of a stricture, subject must undergo a Patency procedure prior to CE. If patency cannot be confirmed through MRE or patency capsule will be discontinued from the study.\n\nSubjects will perform bowel preparation and follow a detailed dietary regimen for CE and IC procedures. Between 45 and 75 minutes after final PEG ingestion, subject will swallow the PillCam Crohn's Capsule. Adequate boosts will be administered, as necessary. Subjects will be allowed to leave clinic after 'Alert 2' is received and if capsule is not yet excreted. Subjects leaving prior to excretion will be instructed to disconnect the recorder at excretion or battery failure (whichever is first).\n\nAfter CE procedure (either same or following day), subject will undergo IC. If the IC is done the following day, subject will stay on clear liquid diet (or NPO, per physician's discretion for sedation)."}], 'classes': [{'title': 'Specificity', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000', 'lowerLimit': '55', 'upperLimit': '87'}]}]}, {'title': 'Negative Predictive Value (NPV)', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000', 'lowerLimit': '64', 'upperLimit': '94'}]}]}, {'title': 'Positive Predictive Value (PPV)', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000', 'lowerLimit': '82', 'upperLimit': '96'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': "Central readers will be used to read all videos/images and analyses will be based on these results. A consensus panel will be used if there are discrepancies in results between modalities at baseline. Capsule endoscopy and IC results will be read by gastroenterologists and MRE results will be read by radiologists.\n\nScores used will be Lewis Score, Simple Endoscopic Score for Crohn's Disease Index (SES-CD) Score and Magnetic Resonance Index of Activity (MaRIA) Score", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sensitivity, Specificity, Negative Predictive Value and Positive Predictive Value for Active CD in Designated Bowel Segments (Proximal Small Bowel Terminal Ileum, and Colon) by Capsule Endoscopy as Compared to IC Plus MRE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MRE, Patency Capsule (if Needed), CE, and IC', 'description': "Subjects will undergo MRE, patency capsule (if necessary), CE, and IC procedures.\n\nIf MRE shows evidence of a stricture, subject must undergo a Patency procedure prior to CE. If patency cannot be confirmed through MRE or patency capsule will be discontinued from the study.\n\nSubjects will perform bowel preparation and follow a detailed dietary regimen for CE and IC procedures. Between 45 and 75 minutes after final PEG ingestion, subject will swallow the PillCam Crohn's Capsule. Adequate boosts will be administered, as necessary. Subjects will be allowed to leave clinic after 'Alert 2' is received and if capsule is not yet excreted. Subjects leaving prior to excretion will be instructed to disconnect the recorder at excretion or battery failure (whichever is first).\n\nAfter CE procedure (either same or following day), subject will undergo IC. If the IC is done the following day, subject will stay on clear liquid diet (or NPO, per physician's discretion for sedation)."}], 'classes': [{'title': 'Sensitivity CE Proximal Small Bowel (PSB)', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000', 'lowerLimit': '82', 'upperLimit': '100'}]}]}, {'title': 'Sensitivity MRE PSB', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000', 'lowerLimit': '53', 'upperLimit': '84'}]}]}, {'title': 'Specificity CE PSB', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000', 'lowerLimit': '76', 'upperLimit': '93'}]}]}, {'title': 'Specificity MRE PSB', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000', 'lowerLimit': '54', 'upperLimit': '76'}]}]}, {'title': 'NPV CE PSB', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000', 'lowerLimit': '90', 'upperLimit': '100'}]}]}, {'title': 'NPV MRE PSB', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000', 'lowerLimit': '71', 'upperLimit': '91'}]}]}, {'title': 'PPV CE PSB', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000', 'lowerLimit': '62', 'upperLimit': '88'}]}]}, {'title': 'PPV MRE PSB', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000', 'lowerLimit': '35', 'upperLimit': '63'}]}]}, {'title': 'Sensitivity CE Terminal ilium (TI)', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000', 'lowerLimit': '84', 'upperLimit': '99'}]}]}, {'title': 'Sensitivity MRE + IC TI', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000', 'lowerLimit': '89', 'upperLimit': '100'}]}]}, {'title': 'Specificity CE TI', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000', 'lowerLimit': '66', 'upperLimit': '91'}]}]}, {'title': 'Specificity MRE + IC TI', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000', 'lowerLimit': '23', 'upperLimit': '53'}]}]}, {'title': 'NPV CE TI', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000', 'lowerLimit': '76', 'upperLimit': '98'}]}]}, {'title': 'NPV MRE + IC TI', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000', 'lowerLimit': '68', 'upperLimit': '100'}]}]}, {'title': 'PPV CE TI', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000', 'lowerLimit': '76', 'upperLimit': '94'}]}]}, {'title': 'PPV MRE + IC TI', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000', 'lowerLimit': '57', 'upperLimit': '78'}]}]}, {'title': 'Sensitivity CE Colon', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000', 'lowerLimit': '62', 'upperLimit': '94'}]}]}, {'title': 'Sensitivity IC Colon', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000', 'lowerLimit': '72', 'upperLimit': '99'}]}]}, {'title': 'Specificity CE Colon', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000', 'lowerLimit': '77', 'upperLimit': '94'}]}]}, {'title': 'Specificity IC Colon', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000', 'lowerLimit': '79', 'upperLimit': '95'}]}]}, {'title': 'NPV CE Colon', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000', 'lowerLimit': '84', 'upperLimit': '98'}]}]}, {'title': 'NPV IC Colon', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000', 'lowerLimit': '88', 'upperLimit': '100'}]}]}, {'title': 'PPV CE Colon', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000', 'lowerLimit': '51', 'upperLimit': '84'}]}]}, {'title': 'PPV IC Colon', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000', 'lowerLimit': '56', 'upperLimit': '88'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': "Central readers will be used to read all videos/images and analyses will be based on these results. A consensus panel will be used if there are discrepancies in results between modalities at baseline. Capsule endoscopy and IC results will be read by gastroenterologists and MRE results will be read by radiologists.\n\nScores used will be Lewis Score, Simple Endoscopic Score for Crohn's Disease Index (SES-CD) Score and Magnetic Resonance Index of Activity (MaRIA) Score", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MRE, Patency Capsule (if Needed), CE, and IC', 'description': "Single-arm study, which includes MRE procedure, Patency Capsule Procedure (if needed), PillCam Crohn's Capsule Endoscopy Procedure and Ileocolonoscopy procedure.\n\nCapsule Endoscopy: At baseline subject will under the PillCam Crohn's Capsule Procedure"}], 'classes': [{'title': 'Preferred PillCam CE', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}]}]}, {'title': 'Preferred IC', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}]}]}, {'title': 'Preferred MRE + IC', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After completion of final procedure, either the same day or by the next business day following procedure completion.', 'description': 'Patient preference of which procedure they preferred (CE, IC or MRE plus IC)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who completed the satisfaction questionnaire and underwent all 3 procedures MRE, CE, and IC and could be evaluated for overall active CD at baseline (i.e., a modified intent-to-treat (mITT).\n\npopulation).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MRE, Patency Capsule (if Needed), CE, and IC', 'description': "Subjects will undergo MRE, patency capsule (if necessary), CE, and IC procedures.\n\nIf MRE shows evidence of a stricture, subject must undergo a Patency procedure prior to CE. If patency not confirmed by MRE or patency capsule, subject is discontinued from study.\n\nSubjects will perform bowel preparation and follow a detailed dietary regimen for CE and IC procedures. Between 45 and 75 minutes after final polyethylene glycol (PEG) ingestion, subject will swallow the PillCam Crohn's Capsule. Adequate boosts will be administered, as necessary. Subjects will be allowed to leave clinic after 'Alert 2' is received and if capsule is not yet excreted. Subjects leaving prior to excretion will be instructed to disconnect the recorder at excretion or battery failure (whichever is first).\n\nAfter CE procedure (either same or following day), subject will undergo IC. If IC is done the following day, subject will stay on clear liquid diet (or NPO (nothing by mouth), per physician discretion)."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '158'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '119'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}]}], 'dropWithdraws': [{'type': 'MRE Stricture or Patency Capsule Failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '187 subjects signed consent. Per the protocol, a subject was not considered "enrolled" until consent was signed and subject met inclusion/exclusion criteria. Of the 187 who signed consent, 158 were considered "enrolled" per the protocol. 29 were "screen failures", i.e. they signed informed consent, but ended up failing inclusion/exclusion.', 'preAssignmentDetails': 'Of the 187 subjects who signed informed consent, 29 failed inclusion/exclusion criteria and were exited from the study. Criteria included labs, which caused some subjects to wash out at this early phase. This left us with 158 subjects. For various reasons, 39 additional subjects were exited prior to all imaging procedures being completed.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'MRE, Patency Capsule (if Needed), CE, and IC', 'description': "Subjects will undergo MRE, patency capsule (if necessary), CE, and IC procedures.\n\nIf MRE shows evidence of a stricture, subject must undergo a Patency procedure prior to CE. If patency cannot be confirmed through MRE or patency capsule will be discontinued from the study.\n\nSubjects will perform bowel preparation and follow a detailed dietary regimen for CE and IC procedures. Between 45 and 75 minutes after final PEG ingestion, subject will swallow the PillCam Crohn's Capsule. Adequate boosts will be administered, as necessary. Subjects will be allowed to leave clinic after 'Alert 2' is received and if capsule is not yet excreted. Subjects leaving prior to excretion will be instructed to disconnect the recorder at excretion or battery failure (whichever is first).\n\nAfter CE procedure (either same or following day), subject will undergo IC. If the IC is done the following day, subject will stay on clear liquid diet (or NPO, per physician's discretion for sedation)."}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '96', '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': '99', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '63', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '36', '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.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Austria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '95', 'groupId': 'BG000'}]}]}, {'title': 'Israel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '28.82', 'spread': '7.36', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m²', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Per-protocol analysis set, included subjects who underwent MRE, CE, and IC (and could be evaluated for CD activity) with no major protocol deviations (violations that may have significant impact on outcomes) and did not meet the following: subject withdraw; capsule remained in stomach or small bowel for entire procedure; system technical failure'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-11-16', 'size': 1241974, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-05-06T14:56', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 187}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-28', 'studyFirstSubmitDate': '2017-07-24', 'resultsFirstSubmitDate': '2020-05-11', 'studyFirstSubmitQcDate': '2017-08-02', 'lastUpdatePostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-28', 'studyFirstPostDateStruct': {'date': '2017-08-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Accuracy of CE Versus IC Plus MRE for Detecting Active Crohn's Disease (CD), by Visualizing the Small Bowel and Colon in Subjects With Know CD and Mucosal Disease.", 'timeFrame': 'Baseline', 'description': "Central readers will be used to read all videos/images and analyses will be based on these results. A consensus panel will be used if there are discrepancies in results between modalities at baseline. Capsule endoscopy and IC results will be read by gastroenterologists and MRE results will be read by radiologists.\n\nScores used will be Lewis Score, Simple Endoscopic Score for Crohn's Disease Index (SES-CD) Score and Magnetic Resonance Index of Activity (MaRIA) Score"}], 'secondaryOutcomes': [{'measure': 'Specificity, Negative Predictive Value, and Positive Predictive Value for Active CD in the Small Bowel and Colon by CE as Compared to IC Plus MRE.', 'timeFrame': 'Baseline', 'description': "Central readers will be used to read all videos/images and analyses will be based on these results. A consensus panel will be used if there are discrepancies in results between modalities at baseline. Capsule endoscopy and IC results will be read by gastroenterologists and MRE results will be read by radiologists.\n\nScores used will be Lewis Score, Simple Endoscopic Score for Crohn's Disease Index (SES-CD) Score and Magnetic Resonance Index of Activity (MaRIA) Score"}, {'measure': 'Sensitivity, Specificity, Negative Predictive Value and Positive Predictive Value for Active CD in Designated Bowel Segments (Proximal Small Bowel Terminal Ileum, and Colon) by Capsule Endoscopy as Compared to IC Plus MRE', 'timeFrame': 'Baseline', 'description': "Central readers will be used to read all videos/images and analyses will be based on these results. A consensus panel will be used if there are discrepancies in results between modalities at baseline. Capsule endoscopy and IC results will be read by gastroenterologists and MRE results will be read by radiologists.\n\nScores used will be Lewis Score, Simple Endoscopic Score for Crohn's Disease Index (SES-CD) Score and Magnetic Resonance Index of Activity (MaRIA) Score"}, {'measure': 'Patient Satisfaction', 'timeFrame': 'After completion of final procedure, either the same day or by the next business day following procedure completion.', 'description': 'Patient preference of which procedure they preferred (CE, IC or MRE plus IC)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Irritable Bowel Disease', 'IBD', 'Mucosal Disease', "Crohn's", 'Inflammatory Bowel Disease'], 'conditions': ['Crohn Disease']}, 'referencesModule': {'references': [{'pmid': '32499275', 'type': 'DERIVED', 'citation': "Bruining DH, Oliva S, Fleisher MR, Fischer M, Fletcher JG; BLINK study group. Panenteric capsule endoscopy versus ileocolonoscopy plus magnetic resonance enterography in Crohn's disease: a multicentre, prospective study. BMJ Open Gastroenterol. 2020 Jun;7(1):e000365. doi: 10.1136/bmjgast-2019-000365."}]}, 'descriptionModule': {'briefSummary': "This study will evaluate the efficacy of capsule endoscopy (CE) versus ileocolonoscopy (IC) plus MRE for detection of active Crohn's disease (CD) in the small bowel in subjects with known CD and mucosal disease.\n\nThe primary objective of the study is to assess the accuracy of CE versus IC plus MRE for detecting active CD, by visualizing the small bowel and colon in subjects with known CD and mucosal disease.\n\nThere will be assessment of mucosal disease activity at baseline. Patient satisfaction questionnaire will be completed at baseline.", 'detailedDescription': "This is a multicenter, prospective, study, evaluating the efficacy of CE versus IC plus MRE for detecting active Crohn's Disease (CD) in the small bowel and colon in subjects with known CD and mucosal disease.\n\nA screening visit will be performed within 30 days prior to baseline procedures to assess pre-procedure eligibility. At this visit the following assessments will be performed: Informed Consent, Inclusion/Exclusion Criteria, Demographics, Montreal Classification, Medical History, Previous GI procedures, Surgical history, Laboratory tests and pregnancy tests.\n\nAt baseline, subjects with known CD on routine evaluation (e.g. history, physical exams, labs) and a recent history of mucosal disease (within the last 2 years and diagnosis based on radiologic, endoscopic, or histologic findings) OR subjects with known CD and active disease based on clinical judgment based on symptoms, laboratory data or other clinical information will undergo Magnetic Resonance Enterography (MRE), Capsule Endoscopy (CE) and Ileocolonoscopy (IC), to assess presence or absence of CD across the small and large bowel. Also, at baseline the following assessments will take place: Laboratory tests, Pregnancy test, Concomitant medications, Patient satisfaction questionnaire and Adverse Events (AE).\n\nSubjects will be exited from the study once all Baseline Procedures have been completed and AEs resolved.\n\nAll CE videos, IC videos and MRE images will be evaluated by central readers.\n\nThe planned number of subjects is 352. Subjects will be enrolled at up to 40 sites in the United States, Israel, and Austria. Study duration is expected to be up to approximately 1.5 years. The expected duration of each subject's participation is approximately 1 month."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject has provided informed consent.\n* Subject is ≥ 18 years of age\n* Subject is willing and able to comply with all aspects of treatment and evaluation schedule.\n* Subject has known CD and a recent history (within last 2 years) of mucosal disease (based on radiologic, endoscopic, or histologic evidence) OR known CD and active disease, based on clinical judgment based on symptoms, laboratory data or other clinical information.\n\nExclusion Criteria:\n\n* Subject has indeterminate, ulcerative, antibiotic-associated colitis.\n* Subject has stool positive for ova and parasite and for Clostridium difficile toxins within 3 months prior to enrollment.\n* Subject with other known infectious cause of abdominal symptoms.\n* Subject with clinical evidence of renal disease with the past 6 months, defined as estimated glomerular filtration rate (GFR) outside the normal reference range.\n* Subject with known history of intestinal obstruction or current obstructive symptoms, such as severe abdominal pain with accompanying nausea or vomiting, based on investigator judgment.\n* Subject with a diagnosis of gastroparesis or small bowel or large bowel dysmotility.\n* Subject with suspected or known bowel obstruction, stricture (defined as unequivocal proximal upstream dilation equal ≥ 2.5 cm), or fistula.\n* Subject has used non-steroidal anti-inflammatory drugs including aspirin, two times per week, during the 4 weeks preceding enrollment. Low dose aspirin regimens (≤ 100 mg daily) are acceptable and not exclusionary.\n* Subject suffers from any condition, such as swallowing problems, that precludes compliance with study and/or device instructions.\n* Subject with cardiac pacemaker or other implanted electromedical device.\n* Subject has an allergy or other known contraindication to the medications used in the study.\n* Subject is pregnant (documented by a positive pregnancy test) or is actively breast-feeding.\n* Subject is considered to be a part of a vulnerable population (eg. prisoners or those without sufficient mental capacity).\n* Subject has a known contraindication to MRE or IC.\n* Subject has participated in a drug or device research study within 30 days of enrollment that may interfere with the subject's safety or ability to participate in the study.\n* Subject has any medical condition that would make it unsafe for them to participate, per Investigator's discretion\n* Subject with ileostomy or colostomy, history of total or subtotal colectomy (including those with ileosigmoidostomy, and ileorectostomy)"}, 'identificationModule': {'nctId': 'NCT03241368', 'acronym': 'BLINK', 'briefTitle': "Clinical Study Comparing PillCam® Crohn's Capsule Endoscopy to Ileocolonoscopy (IC) Plus MRE for Detection of Active CD in the Small Bowel and Colon in Subjects With Known CD and Mucosal Disease.", 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic - MITG'}, 'officialTitle': "Multicenter, Prospective, Study Comparing PillCam® Crohn's Capsule Endoscopy (CE) to Ileocolonoscopy (IC) Plus MRE for Detection of Active Crohn's Disease (CD) in the Small Bowel and Colon in Subjects With Known CD and Mucosal Disease", 'orgStudyIdInfo': {'id': 'COVSBCC0549'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'MRE, Patency Capsule (if needed), CE, and IC', 'description': "Single-arm study, which includes MRE procedure, Patency Capsule Procedure (if needed), PillCam Crohn's Capsule Endoscopy Procedure and Ileocolonoscopy procedure.", 'interventionNames': ['Device: Capsule Endoscopy']}], 'interventions': [{'name': 'Capsule Endoscopy', 'type': 'DEVICE', 'otherNames': ["PillCam Crohn's® Capsule"], 'description': "At baseline subject will under the PillCam Crohn's Capsule Procedure", 'armGroupLabels': ['MRE, Patency Capsule (if needed), CE, and IC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36688', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of South Alabama', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic (Scottsdale, AZ)', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Encore Borland Groover Clinical Research', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Children's Center for Digestive Healthcare", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60153', 'city': 'Maywood', 'state': 'Illinois', 'country': 'United States', 'facility': 'Loyola University - Chicago', 'geoPoint': {'lat': 41.8792, 'lon': -87.84312}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46237', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indianapolis Gastroenterology Research Foundation', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Louisiana State University Health Science Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'University of Massachusetts Memorial Medical Center', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic (Rochester, MN)', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '07962', 'city': 'Morristown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Atlantic Health (Morristown)', 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}, {'zip': '28801', 'city': 'Asheville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Asheville Gastroenterology Associates, PA', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals Cleveland Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '73112', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Digestive Disease Specialists Inc.', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hospital of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '23320', 'city': 'Chesapeake', 'state': 'Virginia', 'country': 'United States', 'facility': 'Gastroenterology Associates of Tidewater', 'geoPoint': {'lat': 36.81904, 'lon': -76.27494}}, {'zip': '24016', 'city': 'Roanoke', 'state': 'Virginia', 'country': 'United States', 'facility': 'Carilion Clinic', 'geoPoint': {'lat': 37.27097, 'lon': -79.94143}}, {'zip': '23434', 'city': 'Suffolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Gastroenterology Institute', 'geoPoint': {'lat': 36.72836, 'lon': -76.58496}}, {'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Virginia Mason Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Allgemeines Krankenhaus - Universitatskliniken Wein', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '5265601', 'city': 'Tel Litwinsky', 'state': 'Ramat Gan', 'country': 'Israel', 'facility': 'Sheba Medical Center', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}], 'overallOfficials': [{'name': 'David Bruining, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic - MITG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}