Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2026-04-14 @ 10:00 PM
Study NCT ID:
NCT02099435
Status:
COMPLETED
Last Update Posted:
2017-01-20
First Post:
2014-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Hemospray for Lower Gastrointestinal Hemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004241', 'term': 'Diverticulum, Colon'}, {'id': 'D016888', 'term': 'Angiodysplasia'}, {'id': 'D003111', 'term': 'Colonic Polyps'}, {'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D004240', 'term': 'Diverticulum'}, {'id': 'D000076385', 'term': 'Diverticular Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007417', 'term': 'Intestinal Polyps'}, {'id': 'D011127', 'term': 'Polyps'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-11-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-19', 'studyFirstSubmitDate': '2014-03-26', 'studyFirstSubmitQcDate': '2014-03-26', 'lastUpdatePostDateStruct': {'date': '2017-01-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of device related adverse events', 'timeFrame': '30 days'}], 'secondaryOutcomes': [{'measure': 'Percentage of recurrent bleeding that occurs outside the blood vessel', 'timeFrame': '30 days'}, {'measure': 'Percentage of hemostasis of lower GI bleeds originating from multiple sources', 'timeFrame': '30 days'}, {'measure': 'All cause mortality', 'timeFrame': '30 days', 'description': 'Mortality within 30 days of index procedure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Gastriointestinal', 'Lower gastriointestinal', 'Digestive', 'Hemostasis', 'Recurrent bleeding', 'Hemospray'], 'conditions': ['Colonic Diverticula', 'Angiodysplasia', 'Colonic Polyp']}, 'referencesModule': {'references': [{'pmid': '30612959', 'type': 'DERIVED', 'citation': 'Hookey L, Barkun A, Sultanian R, Bailey R. Successful hemostasis of active lower GI bleeding using a hemostatic powder as monotherapy, combination therapy, or rescue therapy. Gastrointest Endosc. 2019 Apr;89(4):865-871. doi: 10.1016/j.gie.2018.10.029. Epub 2018 Oct 26.'}]}, 'descriptionModule': {'briefSummary': 'This study is to evaluate the performance of Hemospray for the teatment of nonvariceal lower gastrointestinal bleeding.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'clinical sites', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient in which Hemospray is used to treat an endoscopically confirmed nonvariceal lower GI bleed requiring hemostasis\n\nExclusion Criteria:\n\n* Less than 19 years old\n* Unwilling or unable to sign and date the informed consent\n* Pregnant, lactating or planning to become pregnant within 30 days of the procedure\n* Contraindicated to undergo colonoscopy\n\nMedical/Endoscopic Exclusion Criteria\n\n* Actual or suspected lower GI perforation or fistula\n* Bleeding originating from inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis)\n* Actual or suspected ischemic colitis or infectious colitis\n* Unable to visualize site of active bleeding (such as suspected diverticular bleed where source is unable to be identified)\n* Unable to treat active site of bleeding (e.g., bleeding site cannot be reached by the colonoscope)"}, 'identificationModule': {'nctId': 'NCT02099435', 'briefTitle': 'Study of Hemospray for Lower Gastrointestinal Hemorrhage', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cook Group Incorporated'}, 'officialTitle': 'A Prospective Observational Cohort Study of Hemospray for Lower Gastrointestinal Hemorrhage (APPROACH LGI)', 'orgStudyIdInfo': {'id': '12-007'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hemospray to treat lower GI bleeds', 'interventionNames': ['Device: Hemospray']}], 'interventions': [{'name': 'Hemospray', 'type': 'DEVICE', 'description': 'The Hemospray™ device comes in a 7F kit and a 10F kit. Each kit includes two 220 cm Teflon application catheters, a handle with CO2 cartridge and a syringe containing approximately 20 g of the Hemospray™ material. Hemospray™ is a proprietary inorganic mineral powder that acts as a mechanical barrier when sprayed over a bleeding lesion and the surrounding mucosa.', 'armGroupLabels': ['Hemospray to treat lower GI bleeds']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Royal Alexandra Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hotel Dieu Hospital', 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Montreal General Hospital - McGill University', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cook Group Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}