Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-02-22 @ 10:44 AM
Study NCT ID:
NCT02534233
Status:
COMPLETED
Last Update Posted:
2025-08-01
First Post:
2015-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Effect of CryoBalloon Focal Ablation System on Human Esophageal Epithelium
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001471', 'term': 'Barrett Esophagus'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003452', 'term': 'Cryosurgery'}], 'ancestors': [{'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mcanto1@jhmi.edu', 'phone': '443-287-8083', 'title': 'Dr Marcia Canto, Director of Clinical Research', 'organization': 'Johns Hopkins Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Prospective single arm non-randomized trial, no control subjects.'}}, 'adverseEventsModule': {'timeFrame': 'Post ablation treatment assessment day 1, 7 days, 30 days, and follow up endoscopies up to 12 months', 'description': 'pain (0-10 Likert pain scale,) pain requiring narcotics, dysphagia (0-4 dysphagia score), bleeding, esophageal strictures requiring dilation.', 'eventGroups': [{'id': 'EG000', 'title': 'CryoBalloon Ablation', 'description': 'Patients having ablation of dysplastic tissue in esophagus.\n\nCryoBalloon: Esophageal tissue ablation with focal freezing using nitrous oxide via a single use balloon catheter', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 0, 'seriousNumAtRisk': 53, 'deathsNumAffected': 0, 'seriousNumAffected': 9}], 'seriousEvents': [{'term': 'GI Bleeding', 'notes': 'Post esophageal cryoablation treatment bleeding requiring treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'post cryoablation treatment pain requiring narcotics', 'notes': 'subjects reporting pain requiring narcotics for pain at or between 1, 7, or 30 day follow up calls.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Esophageal stricture requiring dilation', 'notes': 'subject reporting 3 or 4 on dysphagia scale, unable to swallow semi solid or liquid food', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Complete Eradication of Esophageal Dysplasia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CryoBalloon Ablation', 'description': 'Patients having ablation of dysplastic tissue in esophagus.\n\nCryoBalloon: Esophageal tissue ablation with focal freezing using nitrous oxide via a single use balloon catheter'}], 'classes': [{'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': "Evaluate histopathology of esophageal tissue for absence of Barrett's esophagus or squamous dysplasia after cryoablation treatments (assess for complete eradication of dysplasia).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '51 assessable adult patients with data collected at 12 months'}, {'type': 'PRIMARY', 'title': 'Treatment-related Adverse Events Assessed by Pain Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CryoBalloon Ablation', 'description': 'Patients having ablation of dysplastic tissue in esophagus.\n\nCryoBalloon: Esophageal tissue ablation with focal freezing using nitrous oxide via a single use balloon catheter'}], 'classes': [{'title': 'Likert Pain score at 1 day post each cryoablation treatment', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '3'}]}]}, {'title': 'Likert Pain score at 1 week post each cryoablation treatment', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '3'}]}]}, {'title': 'Likert Pain score at 1 month post each (day 31 post each cryoablation treatment', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1 day post treatment (day 2), 1 week post treatment (day 8), and 1 month (day 31)', 'description': 'Evaluate by patient questionnaire for pain on an 11-point scale. The 11-point Likert scale represents a range of discomfort or pain from 0 (no pain) to 10 (extreme pain), which individuals indicate their level of discomfort or pain. Higher score more discomfort.\n\nEach subject is evaluated for post-treatment pain after each cryoablation session. Subjects may have a different number of treatment sessions depending on the extent of disease.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Treatment-related Adverse Events Assessed by Stricture Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CryoBalloon Ablation', 'description': 'Patients having ablation of dysplastic tissue in esophagus.\n\nCryoBalloon: Esophageal tissue ablation with focal freezing using nitrous oxide via a single use balloon catheter'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 12 months', 'description': 'Number of patients with esophageal strictures requiring dilation. Patients reporting dysphagia with solid food, with balloon dilations from index visit to 12 months.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Complete Eradication of Intestinal Metaplasia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CryoBalloon Ablation', 'description': 'Patients having ablation of dysplastic tissue in esophagus.\n\nCryoBalloon: Esophageal tissue ablation with focal freezing using nitrous oxide via a single use balloon catheter'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': "Evaluate histopathology of esophageal tissue for absence of Barrett's esophagus (intestinal metaplasia) after cryoablation", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "41 of the 51 evaluable subjects had Barrett's esophagus (intestinal metaplasia) data collected at 12 months; this outcome measure does not apply to subjects with esophageal squamous dyplasia."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CryoBalloon Ablation', 'description': 'Patients having ablation of dysplastic tissue in esophagus.\n\nCryoBalloon: Esophageal tissue ablation with focal freezing using nitrous oxide via a single use balloon catheter'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}]}, {'type': '12 Month', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': "2 participants with protocol deviations didn't complete", 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': "Individuals who are clinical patients of the Principal Investigator or Co-investigators will be identified as eligible by prior pathology proven biopsies with either Barrett's esophagus with dysplasia or esophageal squamous cell dysplasia.\n\nRecruitment will occur primarily in the outpatient GI clinic but can also be a phone contact and follow-up study consent for review with informed consent call.", 'preAssignmentDetails': '5 subjects were determined ineligible with index endoscopy finding exclusions, strictures restricting therapeutic scope or invasive disease.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'CryoBalloon Ablation', 'description': 'Patients having ablation of dysplastic tissue in esophagus.\n\nCryoBalloon: Esophageal tissue ablation with focal freezing using nitrous oxide via a single use balloon catheter'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '39', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'eligibility criteria is age 18 years or greater', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '64.7', 'spread': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '45', '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': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Likert 11 Point Pain Score (0 no pain-10 worst)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '3'}]}]}], 'paramType': 'MEAN', 'description': 'The 11-point Likert scale represents a range of discomfort or pain from 0 (no pain) to 10 (extreme pain), which individuals indicate their level of discomfort or pain', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-04-29', 'size': 803796, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-05-15T19:19', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-14', 'studyFirstSubmitDate': '2015-08-19', 'resultsFirstSubmitDate': '2025-06-05', 'studyFirstSubmitQcDate': '2015-08-26', 'lastUpdatePostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-07-14', 'studyFirstPostDateStruct': {'date': '2015-08-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Complete Eradication of Esophageal Dysplasia', 'timeFrame': '12 months', 'description': "Evaluate histopathology of esophageal tissue for absence of Barrett's esophagus or squamous dysplasia after cryoablation treatments (assess for complete eradication of dysplasia)."}, {'measure': 'Treatment-related Adverse Events Assessed by Pain Scale', 'timeFrame': '1 day post treatment (day 2), 1 week post treatment (day 8), and 1 month (day 31)', 'description': 'Evaluate by patient questionnaire for pain on an 11-point scale. The 11-point Likert scale represents a range of discomfort or pain from 0 (no pain) to 10 (extreme pain), which individuals indicate their level of discomfort or pain. Higher score more discomfort.\n\nEach subject is evaluated for post-treatment pain after each cryoablation session. Subjects may have a different number of treatment sessions depending on the extent of disease.'}, {'measure': 'Treatment-related Adverse Events Assessed by Stricture Rate', 'timeFrame': 'Up to 12 months', 'description': 'Number of patients with esophageal strictures requiring dilation. Patients reporting dysphagia with solid food, with balloon dilations from index visit to 12 months.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Complete Eradication of Intestinal Metaplasia', 'timeFrame': '12 months', 'description': "Evaluate histopathology of esophageal tissue for absence of Barrett's esophagus (intestinal metaplasia) after cryoablation"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ["barrett's esophagus with dysplasia", 'early esophageal cancer'], 'conditions': ["Barrett's Esophagus", 'Esophageal Squamous Dysplasia', 'Esophageal Cancer']}, 'referencesModule': {'references': [{'pmid': '29626424', 'type': 'RESULT', 'citation': "Canto MI, Shaheen NJ, Almario JA, Voltaggio L, Montgomery E, Lightdale CJ. Multifocal nitrous oxide cryoballoon ablation with or without EMR for treatment of neoplastic Barrett's esophagus (with video). Gastrointest Endosc. 2018 Sep;88(3):438-446.e2. doi: 10.1016/j.gie.2018.03.024. Epub 2018 Apr 5."}, {'pmid': '28720474', 'type': 'RESULT', 'citation': 'Canto MI, Abrams JA, Kunzli HT, Weusten B, Komatsu Y, Jobe BA, Lightdale CJ. Nitrous oxide cryotherapy for treatment of esophageal squamous cell neoplasia: initial multicenter international experience with a novel portable cryoballoon ablation system (with video). Gastrointest Endosc. 2018 Feb;87(2):574-581. doi: 10.1016/j.gie.2017.07.013. Epub 2017 Jul 16.'}], 'seeAlsoLinks': [{'url': 'https://doi.org/10.1016/j.tige.2021.11.007', 'label': "Durability of Cryoballoon Ablation in Neoplastic Barrett's Esophagus"}]}, 'descriptionModule': {'briefSummary': "Assess Cryoablation (CryoBalloon Ablation cryotherapy) for treatment of Dysplastic Barrett's Esophagus, Esophageal Squamous Dysplasia and early Esophageal Cancer. The cryoablation treatment will be offered as an alternative to standard ablation therapies such as Radiofrequency Ablation, Argon Plasma Coagulation and carbon dioxide Cryotherapy).", 'detailedDescription': "Cryoablation (cryotherapy) is an established type of mucosal ablation for treatment of various conditions in the GI tract, including Barrett's esophagus and esophageal cancer. The purpose of this study is to assess the safety, feasibility and performance of cryoablation system (the C2 Focal Cryoablation Device in patients with BE and esophageal squamous dysplasia who need ablation therapy for clinical standard care. The new cryoablation treatment will be offered as an alternative to standard ablation therapies already in place (radiofrequency ablation, carbon dioxide cryotherapy)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients recommended for ablation of either Barrett's esophagus with dysplasia or esophageal squamous dysplasia, scheduled for upper endoscopy.\n\nExclusion Criteria:\n\n* Patient unable to undergo endoscopy,\n* Patients with visible esophageal mass."}, 'identificationModule': {'nctId': 'NCT02534233', 'acronym': 'ColdPlay2', 'briefTitle': 'Evaluation of Effect of CryoBalloon Focal Ablation System on Human Esophageal Epithelium', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Evaluation of Effect of CryoBalloon Focal Ablation System on Human Esophageal Epithelium', 'orgStudyIdInfo': {'id': 'NA_00075654'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CryoBalloon ablation', 'description': 'Patients having ablation of dysplastic tissue in esophagus.', 'interventionNames': ['Device: CryoBalloon']}], 'interventions': [{'name': 'CryoBalloon', 'type': 'DEVICE', 'otherNames': ['Cryoablation'], 'description': 'Esophageal tissue ablation with focal freezing using nitrous oxide via a single use balloon catheter', 'armGroupLabels': ['CryoBalloon ablation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Marcia Canto, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pentax Medical', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}