Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-01-10 @ 2:35 PM
Study NCT ID:
NCT03165058
Status:
COMPLETED
Last Update Posted:
2021-05-07
First Post:
2017-05-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Assessment of Colonic Epithelial Integrity With Mucosal Impedance
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tina.higginbotham@vumc.org', 'phone': '615-322-4643', 'title': 'Tina Higginbotham', 'organization': 'GI Clinical Research Enterprise'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'After colonoscopy, patients are taken to the recovery area and monitored for complications as the sedative wears off. This time period is typically less than 60 minutes.', 'eventGroups': [{'id': 'EG000', 'title': 'Inflammatory Bowel Disease', 'description': 'Patients undergoing standard of care colonoscopy for inflammatory bowel disease (IBD) surveillance will have a MI catheter sensor positioned along the mucosal wall to measure resistance across the mucosa.\n\nmucosal impedance (MI) testing: During routine colonoscopy, consented study participants will have a MI catheter sensor positioned along the mucosal wall to measure resistance across the mucosa. The physician will take measurements in each segment of the colon, including segments that appear inflamed and normal adjacent areas (up to 10 locations). To obtain a stable reading, the sensor must remain in contact with the mucosa for five seconds. The study procedure will add approximately 1-2 minutes of anesthesia time for each participant. Basic demographic information, prior IBD treatments, and prior colonoscopic data will be collected from the medical record following the procedure for those patients who consent to research.', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Patients undergoing standard of care colonoscopy for age appropriate screening will have a MI catheter sensor positioned along the mucosal wall to measure resistance across the mucosa.\n\nmucosal impedance (MI) testing: During routine colonoscopy, consented study participants will have a MI catheter sensor positioned along the mucosal wall to measure resistance across the mucosa. The physician will take measurements in each segment of the colon, including segments that appear inflamed and normal adjacent areas (up to 10 locations). To obtain a stable reading, the sensor must remain in contact with the mucosa for five seconds. The study procedure will add approximately 1-2 minutes of anesthesia time for each participant. Basic demographic information, prior IBD treatments, and prior colonoscopic data will be collected from the medical record following the procedure for those patients who consent to research.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mucosal Impedance Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inflammatory Bowel Disease', 'description': 'Patients undergoing standard of care colonoscopy for inflammatory bowel disease (IBD) surveillance will have a MI catheter sensor positioned along the mucosal wall to measure resistance across the mucosa.\n\nmucosal impedance (MI) testing: During routine colonoscopy, consented study participants will have a MI catheter sensor positioned along the mucosal wall to measure resistance across the mucosa. The physician will take measurements in each segment of the colon, including segments that appear inflamed and normal adjacent areas (up to 10 locations). To obtain a stable reading, the sensor must remain in contact with the mucosa for five seconds. The study procedure will add approximately 1-2 minutes of anesthesia time for each participant. Basic demographic information, prior IBD treatments, and prior colonoscopic data will be collected from the medical record following the procedure for those patients who consent to research.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Patients undergoing standard of care colonoscopy for age appropriate screening will have a MI catheter sensor positioned along the mucosal wall to measure resistance across the mucosa.\n\nmucosal impedance (MI) testing: During routine colonoscopy, consented study participants will have a MI catheter sensor positioned along the mucosal wall to measure resistance across the mucosa. The physician will take measurements in each segment of the colon, including segments that appear inflamed and normal adjacent areas (up to 10 locations). To obtain a stable reading, the sensor must remain in contact with the mucosa for five seconds. The study procedure will add approximately 1-2 minutes of anesthesia time for each participant. Basic demographic information, prior IBD treatments, and prior colonoscopic data will be collected from the medical record following the procedure for those patients who consent to research.'}], 'classes': [{'title': 'Right Colon', 'categories': [{'measurements': [{'value': '1139', 'groupId': 'OG000', 'lowerLimit': '864', 'upperLimit': '1347'}, {'value': '849', 'groupId': 'OG001', 'lowerLimit': '716', 'upperLimit': '1250'}]}]}, {'title': 'Transverse Colon', 'categories': [{'measurements': [{'value': '891', 'groupId': 'OG000', 'lowerLimit': '705', 'upperLimit': '1123'}, {'value': '783', 'groupId': 'OG001', 'lowerLimit': '752', 'upperLimit': '880'}]}]}, {'title': 'Left Colon', 'categories': [{'measurements': [{'value': '673', 'groupId': 'OG000', 'lowerLimit': '547', 'upperLimit': '763'}, {'value': '699', 'groupId': 'OG001', 'lowerLimit': '594', 'upperLimit': '740'}]}]}, {'title': 'Rectum', 'categories': [{'measurements': [{'value': '767', 'groupId': 'OG000', 'lowerLimit': '618', 'upperLimit': '991'}, {'value': '531', 'groupId': 'OG001', 'lowerLimit': '418', 'upperLimit': '604'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '15 minutes', 'description': 'compare the mucosal impedance values between subjects with IBD and controls', 'unitOfMeasure': 'ohms', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is missing for 4 participants from each group either due to incomplete mucosal impedance (MI) readings or indeterminate disease status.'}, {'type': 'SECONDARY', 'title': 'Difference in Inflamed and Normal Mucosa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Inflammatory Bowel Disease', 'description': 'Patients undergoing standard of care colonoscopy for inflammatory bowel disease (IBD) surveillance will have a MI catheter sensor positioned along the mucosal wall to measure resistance across the mucosa.\n\nmucosal impedance (MI) testing: During routine colonoscopy, consented study participants will have a MI catheter sensor positioned along the mucosal wall to measure resistance across the mucosa. The physician will take measurements in each segment of the colon, including segments that appear inflamed and normal adjacent areas (up to 10 locations). To obtain a stable reading, the sensor must remain in contact with the mucosa for five seconds. The study procedure will add approximately 1-2 minutes of anesthesia time for each participant. Basic demographic information, prior IBD treatments, and prior colonoscopic data will be collected from the medical record following the procedure for those patients who consent to research.'}], 'timeFrame': '15 minutes', 'description': 'compare the mucosal impedance values in inflamed and normal areas in IBD patients', 'reportingStatus': 'POSTED', 'populationDescription': 'There were no patients where inflamed mucosa was directly adjacent to normal mucosa to be able to measure impedance in both'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Inflammatory Bowel Disease', 'description': 'Patients undergoing standard of care colonoscopy for inflammatory bowel disease (IBD) surveillance will have a MI catheter sensor positioned along the mucosal wall to measure resistance across the mucosa.\n\nmucosal impedance (MI) testing: During routine colonoscopy, consented study participants will have a MI catheter sensor positioned along the mucosal wall to measure resistance across the mucosa. The physician will take measurements in each segment of the colon, including segments that appear inflamed and normal adjacent areas (up to 10 locations). To obtain a stable reading, the sensor must remain in contact with the mucosa for five seconds. The study procedure will add approximately 1-2 minutes of anesthesia time for each participant. Basic demographic information, prior IBD treatments, and prior colonoscopic data will be collected from the medical record following the procedure for those patients who consent to research.'}, {'id': 'FG001', 'title': 'Control', 'description': 'Patients undergoing standard of care colonoscopy for age appropriate screening will have a MI catheter sensor positioned along the mucosal wall to measure resistance across the mucosa.\n\nmucosal impedance (MI) testing: During routine colonoscopy, consented study participants will have a MI catheter sensor positioned along the mucosal wall to measure resistance across the mucosa. The physician will take measurements in each segment of the colon, including segments that appear inflamed and normal adjacent areas (up to 10 locations). To obtain a stable reading, the sensor must remain in contact with the mucosa for five seconds. The study procedure will add approximately 1-2 minutes of anesthesia time for each participant. Basic demographic information, prior IBD treatments, and prior colonoscopic data will be collected from the medical record following the procedure for those patients who consent to research.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Inflammatory Bowel Disease', 'description': 'Patients undergoing standard of care colonoscopy for inflammatory bowel disease (IBD) surveillance will have a MI catheter sensor positioned along the mucosal wall to measure resistance across the mucosa.\n\nmucosal impedance (MI) testing: During routine colonoscopy, consented study participants will have a MI catheter sensor positioned along the mucosal wall to measure resistance across the mucosa. The physician will take measurements in each segment of the colon, including segments that appear inflamed and normal adjacent areas (up to 10 locations). To obtain a stable reading, the sensor must remain in contact with the mucosa for five seconds. The study procedure will add approximately 1-2 minutes of anesthesia time for each participant. Basic demographic information, prior IBD treatments, and prior colonoscopic data will be collected from the medical record following the procedure for those patients who consent to research.'}, {'id': 'BG001', 'title': 'Control', 'description': 'Patients undergoing standard of care colonoscopy for age appropriate screening will have a MI catheter sensor positioned along the mucosal wall to measure resistance across the mucosa.\n\nmucosal impedance (MI) testing: During routine colonoscopy, consented study participants will have a MI catheter sensor positioned along the mucosal wall to measure resistance across the mucosa. The physician will take measurements in each segment of the colon, including segments that appear inflamed and normal adjacent areas (up to 10 locations). To obtain a stable reading, the sensor must remain in contact with the mucosa for five seconds. The study procedure will add approximately 1-2 minutes of anesthesia time for each participant. Basic demographic information, prior IBD treatments, and prior colonoscopic data will be collected from the medical record following the procedure for those patients who consent to research.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-08-08', 'size': 436189, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-05-14T12:28', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2019-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-05', 'studyFirstSubmitDate': '2017-05-22', 'resultsFirstSubmitDate': '2020-05-19', 'studyFirstSubmitQcDate': '2017-05-22', 'lastUpdatePostDateStruct': {'date': '2021-05-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-19', 'studyFirstPostDateStruct': {'date': '2017-05-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mucosal Impedance Values', 'timeFrame': '15 minutes', 'description': 'compare the mucosal impedance values between subjects with IBD and controls'}], 'secondaryOutcomes': [{'measure': 'Difference in Inflamed and Normal Mucosa', 'timeFrame': '15 minutes', 'description': 'compare the mucosal impedance values in inflamed and normal areas in IBD patients'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inflammatory Bowel Diseases']}, 'descriptionModule': {'briefSummary': 'In this study, the investigators propose to use mucosal impedance (MI), a minimally invasive technology, to detect mucosal damage (i.e. barrier dysfunction) based on mucosal conductivity changes in the colonic epithelium.', 'detailedDescription': "The intestinal epithelium functions to separate luminal contents from the interstitium. Increased intestinal permeability can represent compromise of the epithelium's integrity. Prior research has demonstrated that defects in intestinal barrier function are associated with inflammatory bowel disease (IBD) and increased intestinal permeability can be important in the maintenance of remission in IBD patients. There is currently not a convenient way to measure colonic epithelial barrier function in real time which could provide clinically relevant information ."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will be identified by physicians in the endoscopy center at Vanderbilt. Those patients undergoing colonoscopy for either the indication of screening colonoscopy or IBD surveillance will be asked, on the day of their colonoscopy, whether they want to participate in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Men and women over the age of 18 with a diagnosis of IBD (Ulcerative Colitis or Crohn's Disease)\n* Men and women undergoing screening colonoscopy (typical age would be 50 or greater but there are exceptions)\n\nExclusion Criteria:\n\n* Age less than 18 years old\n* Patients unable to give informed consent\n* Patients with history of colonic surgeries\n* Patients with history of colonic motility disorder"}, 'identificationModule': {'nctId': 'NCT03165058', 'briefTitle': 'Assessment of Colonic Epithelial Integrity With Mucosal Impedance', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Assessment of Colonic Epithelial Integrity With Mucosal Impedance', 'orgStudyIdInfo': {'id': '160534'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Inflammatory Bowel Disease', 'description': 'Patients undergoing standard of care colonoscopy for inflammatory bowel disease (IBD) surveillance will have a MI catheter sensor positioned along the mucosal wall to measure resistance across the mucosa.', 'interventionNames': ['Diagnostic Test: mucosal impedance (MI) testing']}, {'label': 'control', 'description': 'Patients undergoing standard of care colonoscopy for age appropriate screening will have a MI catheter sensor positioned along the mucosal wall to measure resistance across the mucosa.', 'interventionNames': ['Diagnostic Test: mucosal impedance (MI) testing']}], 'interventions': [{'name': 'mucosal impedance (MI) testing', 'type': 'DIAGNOSTIC_TEST', 'description': 'During routine colonoscopy, consented study participants will have a MI catheter sensor positioned along the mucosal wall to measure resistance across the mucosa. The physician will take measurements in each segment of the colon, including segments that appear inflamed and normal adjacent areas (up to 10 locations). To obtain a stable reading, the sensor must remain in contact with the mucosa for five seconds. The study procedure will add approximately 1-2 minutes of anesthesia time for each participant. Basic demographic information, prior IBD treatments, and prior colonoscopic data will be collected from the medical record following the procedure for those patients who consent to research.', 'armGroupLabels': ['Inflammatory Bowel Disease', 'control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center Endoscopy Laboratory', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Yash Choksi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Yash Amit Choksi', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}