Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT02953418
Status:
TERMINATED
Last Update Posted:
2020-08-12
First Post:
2016-10-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
RFA for Flat Type High-grade and Medium-grade Intraepithelial Squamous Neoplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078703', 'term': 'Radiofrequency Ablation'}], 'ancestors': [{'id': 'D000078702', 'term': 'Radiofrequency Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Tumordirectedtherapiesclinical@Medtronic.com', 'phone': '303-882-6759', 'title': 'Director of Clinical Affairs', 'organization': 'Medtronic MITG-RGI'}, 'certainAgreement': {'otherDetails': "Institution and Investigator shall not publish the Study results until after Medtronic's multi-site publication or until the elapse of 12 months from the close of the study at all Study sites, whichever occurs earlier.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study was terminated early, therefore there was a limited data set for analysis.'}}, 'adverseEventsModule': {'timeFrame': 'Safety data was evaluated throughout the entirety of follow up, after the study was terminated safety was evaluated for 90 days post RFA procedure.', 'eventGroups': [{'id': 'EG000', 'title': 'Radiofrequency Ablation', 'description': 'Step-wise endoscopic RFA with the Barrx™ Flex Radiofrequency Ablation System using will be performed in 3 month intervals up to 12 months.\n\nRadiofrequency ablation: RFA', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 1, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Oesophageal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Oesophageal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'H1N1Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Squamous cell carcinoma of the hypopharynx', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects With Complete Response (CR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiofrequency Ablation', 'description': 'Step-wise endoscopic RFA with the Barrx™ Flex Radiofrequency Ablation System using will be performed in 3 month intervals up to 12 months.\n\nRadiofrequency ablation: RFA'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 month', 'description': 'The primary endpoint is the percentage of subjects with "complete response (CR)", defined as complete eradication of squamous histological abnormalities (MGIN or worse) within the treatment area (TA) at 12 months after the initial treatment session', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As the study was terminated early, only 8 subjects completed 12 month follow up.'}, {'type': 'SECONDARY', 'title': 'Complete Response at Three Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiofrequency Ablation', 'description': 'Step-wise endoscopic RFA with the Barrx™ Flex Radiofrequency Ablation System using will be performed in 3 month intervals up to 12 months.\n\nRadiofrequency ablation: RFA'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 Months', 'description': 'Number of patients with a CR after primary RFA, defined as absence of MGIN or worse in any of the biopsies from the treatment area at the three months visit', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Complete Response Within the Treatment Area', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiofrequency Ablation', 'description': 'Step-wise endoscopic RFA with the Barrx™ Flex Radiofrequency Ablation System using will be performed in 3 month intervals up to 12 months.\n\nRadiofrequency ablation: RFA'}], 'classes': [{'title': '3 Month Complete Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': '6 Month Complete Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': '12 Month Complete Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3, 6 and 12 Month', 'description': 'Number of patients demonstrating complete response within the treatment area (TA), defined as detection of ESCC in biopsy or resection specimen at any time within the first 12 months.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all patients in the study were followed for the duration of the treatment phase of 12 months due to study termination. Therefore, primary and secondary endpoint data sample size may vary based on how many visits each subject completed.'}, {'type': 'SECONDARY', 'title': 'Disease Progression Outside the Treatment Area', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiofrequency Ablation', 'description': 'Step-wise endoscopic RFA with the Barrx™ Flex Radiofrequency Ablation System using will be performed in 3 month intervals up to 12 months.\n\nRadiofrequency ablation: RFA'}], 'classes': [{'title': 'Primary RFA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '3-Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': '6-Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': '9-Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': '12-Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Initial, 3, 6, 9 and 12 month', 'description': 'Proportion of patients demonstrating MGIN or worse outside the TA during treatment phase or follow-up', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all patients in the study were followed for the duration of the treatment phase of 12 months due to study termination. Therefore, primary and secondary endpoint data sample size may vary based on how many visits each subject completed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Radiofrequency Ablation', 'description': 'Step-wise endoscopic RFA with the Barrx™ Flex Radiofrequency Ablation System using will be performed in 3 month intervals up to 12 months.\n\nRadiofrequency ablation: RFA'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Radiofrequency Ablation', 'description': 'Step-wise endoscopic RFA with the Barrx™ Flex Radiofrequency Ablation System using will be performed in 3 month intervals up to 12 months.\n\nRadiofrequency ablation: RFA'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.41', 'spread': '8.03', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Chinese', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height (cm)', 'classes': [{'categories': [{'measurements': [{'value': '162.88', 'spread': '7.79', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight (kg)', 'classes': [{'categories': [{'measurements': [{'value': '64.93', 'spread': '10.30', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-07-12', 'size': 401835, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-07-16T15:47', 'hasProtocol': False}, {'date': '2018-03-15', 'size': 1771166, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-07-16T15:47', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'whyStopped': 'Enrollment taking longer than expected.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-07-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-29', 'studyFirstSubmitDate': '2016-10-28', 'resultsFirstSubmitDate': '2020-07-16', 'studyFirstSubmitQcDate': '2016-10-31', 'lastUpdatePostDateStruct': {'date': '2020-08-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-07-29', 'studyFirstPostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects With Complete Response (CR)', 'timeFrame': '12 month', 'description': 'The primary endpoint is the percentage of subjects with "complete response (CR)", defined as complete eradication of squamous histological abnormalities (MGIN or worse) within the treatment area (TA) at 12 months after the initial treatment session'}], 'secondaryOutcomes': [{'measure': 'Complete Response at Three Months', 'timeFrame': '3 Months', 'description': 'Number of patients with a CR after primary RFA, defined as absence of MGIN or worse in any of the biopsies from the treatment area at the three months visit'}, {'measure': 'Complete Response Within the Treatment Area', 'timeFrame': '3, 6 and 12 Month', 'description': 'Number of patients demonstrating complete response within the treatment area (TA), defined as detection of ESCC in biopsy or resection specimen at any time within the first 12 months.'}, {'measure': 'Disease Progression Outside the Treatment Area', 'timeFrame': 'Initial, 3, 6, 9 and 12 month', 'description': 'Proportion of patients demonstrating MGIN or worse outside the TA during treatment phase or follow-up'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Esophageal Squamous Cell Neoplasia (ESCN)']}, 'descriptionModule': {'briefSummary': 'Multicenter, prospective cohort clinical trial in greater China'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient is 18-85 years of age\n2. Patient has evidence of ESCN, within the last 3 months, patient demonstrated a new diagnosis or a reconfirmed diagnosis of squamous MGIN and/or HGIN of the esophagus\n3. On endoscopic examination, subject has at least one USL that measures at least 3 cm in at least one dimension and greater than ¼ of the esophageal circumference and has MGIN or HGIN on biopsy, confirmed by central pathologist\n4. All lesions in the esophagus are completely flat (Paris type 0-IIb), both on WLE and Lugol\'s chromoendoscopy\n5. The maximum allowable linear length of "USL-bearing esophagus" is 12 cm\n6. Baseline endoscopic ultrasound (EUS) (if applicable) shows no exclusionary findings for the trial\n7. Computed Tomography )CT( scan of chest and upper third of the abdomen (if applicable) shows no exclusionary findings for the trial\n8. Based on the judgment of the study endoscopist, the patient is eligible for treatment, follow-up endoscopy, and biopsy as required by the protocol\n9. EMR or ESD occurred \\> 3 months before enrollment, patients may be eligible for the study if procedure was curative (negative margins and no risk of lymph node involvement) and the patient has no other findings concerning for cancer\n10. The subject is willing to provide written, informed consent to participate in this clinical study and understands the responsibilities of trial participation\n\nExclusion Criteria:\n\n1. Patient has esophageal squamous cell carcinoma (ESCC)\n2. Any non-flat (Paris type 0-I, 0-IIa, 0-IIc, 0-III) abnormalities anywhere in the esophagus\n3. Any abnormalities under WLE, Lugol\'s chromoendoscopy or NBI that are suspicious for ESCC anywhere in the esophagus (e.g. \'pink sign\' USL, defined as a color change after Lugol\'s staining: initially whitish yellow and pink 2-3 minutes later)\n4. Any USL with MGIN or worse on biopsy outside the treatment area\n5. Esophageal stricture preventing passage of a therapeutic endoscope\n6. Prior endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) which occurred \\< 3 months before enrollment\n7. Any esophageal dilation in the past 12 months\n8. Any history of a non-squamous cell cancer of the esophagus, or any history of a squamous cell cancer of the esophagus (any stage)\n9. Any previous ablative therapy within the esophagus (photodynamic therapy, multipolar electrical coagulation, argon plasma coagulation, laser treatment, or other) or any radiation therapy to the esophagus\n10. Previous esophageal surgery, except fundoplication without complications (i.e., no slippage, dysphagia, etc.)\n11. Evidence of esophageal varices detected within last 6 months or at initial RFA procedure\n12. Patient has active reflux esophagitis grade C or D\n13. Evidence of eosinophilic esophagitis on endoscopy and/or histology\n14. Inner diameter of the esophagus measuring \\<18 mm\n15. Report of uncontrolled coagulopathy with international normalized ratio (INR) \\> 2 or platelet count \\<75,000 platelets per µL (note: a complete blood count is not required for all subjects in this study)\n16. Patient is using anti-thrombotic agents that cannot be discontinued 7 days before and after therapeutic sessions\n17. Patient has an implantable pacing device (examples: automated implantable cardioverter defibrillator, neurostimulator, cardiac pacemaker) and has not received clearance for enrollment in this study by specialist responsible for the pacing device\n18. Patient has life expectancy less than 5 years\n19. Patient suffers from psychiatric or other illness and/or has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post- treatment instructions, or follow-up guidelines\n20. Patient is considered to be part of a vulnerable population (e.g. prisoners or those without sufficient mental capacity)\n21. The subject has participated in an investigational drug or device research study within 30 days of enrollment that would interfere with this study\n22. Patient is pregnant or has plans to become pregnant in the ensuing 12 months (confirmation of non-pregnant status in women of child-bearing age and ability required with urine or blood test to be eligible)'}, 'identificationModule': {'nctId': 'NCT02953418', 'acronym': 'REACH', 'briefTitle': 'RFA for Flat Type High-grade and Medium-grade Intraepithelial Squamous Neoplasia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic - MITG'}, 'officialTitle': 'A Multicenter Trial of Endoscopic Radiofrequency Ablation for High-grade and Low-grade Intraepithelial Squamous Neoplasia Using the Barrx™ Flex Radiofrequency Ablation System', 'orgStudyIdInfo': {'id': 'COVB3050540'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Radiofrequency ablation', 'description': 'Step-wise endoscopic RFA with the Barrx™ Flex Radiofrequency Ablation System using will be performed in 3 month intervals up to 12 months.', 'interventionNames': ['Device: Radiofrequency ablation']}], 'interventions': [{'name': 'Radiofrequency ablation', 'type': 'DEVICE', 'otherNames': ['The Barrx™ Flex Radiofrequency Ablation System'], 'description': 'RFA', 'armGroupLabels': ['Radiofrequency ablation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100021', 'city': 'Beijing', 'country': 'China', 'facility': 'Cancer Institute and Hospital, Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Amanda Cafaro, RN', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medtronic Gastrointestinal & Hepatology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic - MITG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}