Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2026-03-03 @ 7:40 PM
Study NCT ID:
NCT02729727
Status:
COMPLETED
Last Update Posted:
2022-04-28
First Post:
2016-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study to Evaluate CryoBalloon™ Ablation System in Patients Undergoing Esophagectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2016-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-21', 'studyFirstSubmitDate': '2016-03-14', 'studyFirstSubmitQcDate': '2016-03-31', 'lastUpdatePostDateStruct': {'date': '2022-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of CryoBalloon Ablation System', 'timeFrame': 'through study completion, an average of 2 weeks', 'description': 'Incidence of device related serious adverse events'}], 'secondaryOutcomes': [{'measure': 'Device Performance', 'timeFrame': 'through study completion, an average of 2 weeks', 'description': 'Ease of deployment of the CryoBalloon, procedure time, endoscope compatibility, device malfunction.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Esophageal Cancer']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and treatment effect of the CryoBalloon™ Full Ablation System for the ablation of human esophageal epithelium in patients scheduled to undergo esophagectomy', 'detailedDescription': 'The primary outcomes for the study are the safety and treatment effect of the CryoBalloon™ Ablation System. An esophagectomy will be performed as scheduled following the ablation procedure; histopathological analysis of surgically-resected specimens will be performed to determine the treatment effect.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Up to two (2) areas of 3 cm each non-ulcerated, columnar lined esophagus or squamous linted tissue suitable for ablation\n* Older than 18 years of age at the time of consent\n* Requires a clinically-necessary esophagectomy for esophageal cancer\n* Patient has provided written informed consent using the Informed Consent Form approved by the Institution's reviewing Medical Ethics Committee (MEC)\n\nExclusion Criteria:\n\n* Patient refuses or is unable to provide written informed consent\n* Patient has esophageal narrowing limiting access to the intended site of ablation"}, 'identificationModule': {'nctId': 'NCT02729727', 'briefTitle': 'Clinical Study to Evaluate CryoBalloon™ Ablation System in Patients Undergoing Esophagectomy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pentax Medical'}, 'officialTitle': 'Clinical Study to Evaluate the CryoBalloon™ Full Ablation System for the Ablation of Human Esophageal Epithelium in Patients Undergoing Esophagectomy', 'orgStudyIdInfo': {'id': 'CP-0008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Single Arm', 'description': 'To evaluate safety and treatment effect of the CryoBalloon Ablation System for the Ablation of human esophageal epithelium in patients scheduled to undergo esophagectomy', 'interventionNames': ['Device: CryoBalloon Ablation System']}], 'interventions': [{'name': 'CryoBalloon Ablation System', 'type': 'DEVICE', 'description': 'Tissue Ablation using CryoBalloon Ablation System', 'armGroupLabels': ['Single Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1105', 'city': 'Amsterdam', 'state': 'North Holland', 'country': 'Netherlands', 'facility': 'Academic Medical Centre Amsterdam', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'overallOfficials': [{'name': 'Jacques J.G.H.M. Bergman, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AMC Medical Research B.V.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pentax Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}