Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-03-01 @ 2:26 AM
Study NCT ID:
NCT03077594
Status:
COMPLETED
Last Update Posted:
2023-01-18
First Post:
2017-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characterization of the Neo-squamous Epithelial Barrier
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Esophageal biopsies'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-06-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-16', 'studyFirstSubmitDate': '2017-02-01', 'studyFirstSubmitQcDate': '2017-03-07', 'lastUpdatePostDateStruct': {'date': '2023-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mucosal Impedance as measured by an endoscopic probe', 'timeFrame': 'Up to two years', 'description': "Assess the mucosal impedance of neosquamous epithelium after successful treatment of Barrett's Esophagus."}], 'secondaryOutcomes': [{'measure': 'Tissue levels of prostaglandin E2', 'timeFrame': 'Up to two years', 'description': "Assess the levels of prostaglandin E2 in neosquamous epithelium after successful treatment of Barrett's Esophagus."}, {'measure': 'Intracellular space', 'timeFrame': 'Up to two years', 'description': "Assess the intercellular space in neosquamous epithelium following successful treatment of Barrett's Esophagus with use of transmission electron microscopy."}, {'measure': 'Volumetric Laser Endomicroscopy', 'timeFrame': 'Up to two years', 'description': 'Assess and measure precise thickness of and area of subsquamous structions underneath the neosquamous epithelium.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Barrett's Esophagus With Dysplasia"]}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': "To prospectively assess the functional aspects of the the esophageal squamous epithelial barrier and correlate this with tissue inflammation and intercellular space dilation in patients who have successfully completed endoscopic radiofrequency ablation versus balloon cryotherapy for Barrett's Esophagus related metaplasia.", 'detailedDescription': 'The investigators will measure and correlate mucosal impedance (measured using a novel endoscopic mucosal impedance catheter), intercellular space as measured with transmission electron microscopy and tissue levels of prostaglandin E2 in patients undergoing surveillance following successful endoscopic therapy (defined as two negative endoscopic surveillance histology for intestinal metaplasia).\n\nMucosal impedance will be measured by an endoscopic probe. Research biopsies will also be obtained for measurement of tissue levels of prostaglandin E2 and intracellular space with transmission electron microscopy.\n\nVolumetric laser endomicroscopy will measure the precise thickness of and area of subsquamous structures underneath the neosquamous epithelium.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have successfully completed endoscopic ablation (one endoscopy with no evidence of intestinal metaplasia).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (age 18-90) who underwent an ablative program for BE\n\nExclusion Criteria:\n\n* Patients that have not achieved complete remission of intestinal metaplasia.\n* Patients unable to consent.\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT03077594', 'briefTitle': 'Characterization of the Neo-squamous Epithelial Barrier', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': "Prospective Characterization of the Neo-squamous Epithelial Barrier Following Successful Endoscopic Therapy in Barrett's Esophagus", 'orgStudyIdInfo': {'id': '16-005490'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Successfully ablated patients', 'description': 'Mucosal impedance will be performed at the time of clinically indicated endoscopy. Research biopsies will be obtained during clinically indicated endoscopy.', 'interventionNames': ['Device: Mucosal Impedance', 'Other: Research Biopsies']}, {'label': 'Successfully ablated patients - VLE', 'description': 'Mucosal impedance will be performed at the time of clinically indicated endoscopy. Research biopsies will be obtained during clinically indicated endoscopy. Volumetric laser endomicroscopy (VLE) will be done.', 'interventionNames': ['Device: Mucosal Impedance', 'Other: Research Biopsies', 'Device: Volumetric Laser Endomicroscopy']}], 'interventions': [{'name': 'Mucosal Impedance', 'type': 'DEVICE', 'description': 'Aim 1: Mucosal impedance will be measured by an endoscopic probe 1 cm above the gastroesophageal junction, 5 cm above the gastroesophageal junction and in the proximal esophagus in an area not exposed to the index therapeutic radiofrequency ablation. Aim 2: Mucosal impedance will be measured 1 cm above gastroesophageal junction, 1 cm below previous squamous columnar junction, 1 cm above previous squamocolumnar junction.', 'armGroupLabels': ['Successfully ablated patients', 'Successfully ablated patients - VLE']}, {'name': 'Research Biopsies', 'type': 'OTHER', 'description': 'Aim 1: Research biopsies will be obtained at 1 cm above the gastroesophageal junction, 5 cm above the gastroesophageal junction, and in the proximal esophagus in an area not exposed to the index therapeutic radiofrequency ablation. Aim 2: Aim 2: Research biopsies will be taken 1 cm above gastroesophageal junction, 1 cm below previous squamous columnar junction, 1 cm above previous squamocolumnar junction.', 'armGroupLabels': ['Successfully ablated patients', 'Successfully ablated patients - VLE']}, {'name': 'Volumetric Laser Endomicroscopy', 'type': 'DEVICE', 'description': 'Aim 2: Volumetric laser endomicroscopy will be done and marked at 1 cm above gastroesophageal junction, 1 cm below previous squamous columnar junction, 1 cm above previous squamocolumnar junction.', 'armGroupLabels': ['Successfully ablated patients - VLE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Prasad Iyer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Prasad G. Iyer', 'investigatorAffiliation': 'Mayo Clinic'}}}}