Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2026-01-24 @ 8:09 AM
Study NCT ID:
NCT02233933
Status:
UNKNOWN
Last Update Posted:
2014-09-09
First Post:
2014-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of Argon Plasma Coagulation Versus APC and APC and Hemospray in the Treatment of Radiation Proctitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006471', 'term': 'Gastrointestinal Hemorrhage'}, {'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C581750', 'term': 'hemospray'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-09-08', 'studyFirstSubmitDate': '2014-08-28', 'studyFirstSubmitQcDate': '2014-09-08', 'lastUpdatePostDateStruct': {'date': '2014-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cessation of rectal bleeding', 'timeFrame': '12 months', 'description': 'treatment of one group of patients with Radiation Proctitis with Argon Plasma Coagulator ( APC) and a second group will be treated with APC and Hemospray'}], 'secondaryOutcomes': [{'measure': 'number of treatments required to achieve cessation of rectal bleeding', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['radiation proctitis', 'bleeding', 'therapy'], 'conditions': ['Rectal Bleeding']}, 'descriptionModule': {'briefSummary': 'Randomized trial of Argon Plasma Coagulation compared with Argon Plasma Coagulation and Hemospray in the therapy of bleeding from Radiation Proctitis', 'detailedDescription': '20 patients with Radiation Proctitis will be randomized to receive either Argon Plasma Coagulation therapy alone or therapy with APC followed by Hemospray administration ;the treatment in each arm is administered during a sigmoidoscopic examination'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* bleeding from radiation proctitis\n\nExclusion Criteria:\n\n* pregnancy bleeding diathesis'}, 'identificationModule': {'nctId': 'NCT02233933', 'briefTitle': 'Trial of Argon Plasma Coagulation Versus APC and APC and Hemospray in the Treatment of Radiation Proctitis', 'organization': {'class': 'OTHER', 'fullName': 'British Columbia Cancer Agency'}, 'officialTitle': 'Randomized Trial of Argon Plasma Coagulation Versus Argon Plasma Coagulation and Hemospray in the Therapy of Radiation Proctitis', 'orgStudyIdInfo': {'id': 'RadP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'argon plasma coagulation', 'description': 'argon plasma coagulation of radiation proctitis', 'interventionNames': ['Other: Hemospray']}, {'type': 'EXPERIMENTAL', 'label': 'argon plasma coagulator and hemospray', 'description': 'treatment of radiation proctitis with argon plasma coagulator followed by application of hemospray', 'interventionNames': ['Other: Hemospray']}], 'interventions': [{'name': 'Hemospray', 'type': 'OTHER', 'description': 'hemospray is used after argon coagulation to stop bleeding', 'armGroupLabels': ['argon plasma coagulation', 'argon plasma coagulator and hemospray']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'contacts': [{'name': 'Alan A Weiss, MD', 'role': 'CONTACT', 'email': 'aweiss@bccancer.bc.ca', 'phone': '778 9979332'}, {'name': 'Alan A Weiss, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'British Columbia Cancer Clinic', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'centralContacts': [{'name': 'Alan A Weiss, MD', 'role': 'CONTACT', 'email': 'aweiss@bccancer.bc.ca', 'phone': '7789979332'}], 'overallOfficials': [{'name': 'Alan A Weiss, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'BCCA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'British Columbia Cancer Agency', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investgator', 'investigatorFullName': 'Alan Weiss', 'investigatorAffiliation': 'British Columbia Cancer Agency'}}}}