Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2026-01-01 @ 9:41 PM
Study NCT ID:
NCT04629768
Status:
UNKNOWN
Last Update Posted:
2020-11-16
First Post:
2020-08-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Purastat Prevention Delayed Bleeding Duodenum
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 59}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-09', 'studyFirstSubmitDate': '2020-08-31', 'studyFirstSubmitQcDate': '2020-11-09', 'lastUpdatePostDateStruct': {'date': '2020-11-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The presence of active bleeding or high risk stigma of bleeding', 'timeFrame': '1 day after EMR', 'description': 'On an EGD, performed the day after the duodenal EMR with PuraStat application, the presence of active bleeding or the presence of visible vessels after removal of a blood clot will be observed'}], 'secondaryOutcomes': [{'measure': 'The presence of clinical signs of delayed bleeding', 'timeFrame': "'During hospital stay, assessed up to 10 days' and '30 days after EMR'", 'description': 'The presence of hematemesis, melena, hemoglobin/hematocrit drop, hypotension or shock will be observed in the patients that had duodenal EMR with PuraStat application.'}, {'measure': 'The presence of other adverse events', 'timeFrame': "'During hospital stay, assessed up to 10 days' and '30 days after EMR'", 'description': 'The presence of adverse events like perforation, severe pain, fever… will be observed in the patients that had duodenal EMR with Purastat application'}, {'measure': 'The feasibility of PuraStat application: Amount', 'timeFrame': 'During EMR procedure', 'description': 'The amount of PuraStat will be investigated: Volume in mL'}, {'measure': 'The feasibility of PuraStat application: Ease', 'timeFrame': 'During EMR procedure', 'description': 'The ease of application will be investigated: Questionnaire will be answered by the endoscopist.'}, {'measure': 'The feasibility of Purastat application: Coverage', 'timeFrame': 'During EGD procedure', 'description': 'Is PuraStat covering the resection defect the day after the EMR? This will be investigated by questionnaire that will be answered by the endoscopist who performs the EGD'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Purastat', 'EMR duodenum'], 'conditions': ['Lesion; Duodenum']}, 'descriptionModule': {'briefSummary': 'PuraStat is a viscous solution of synthetic peptides that provides a physical barrier to facilitate hemostasis. It is indicated for haemostasis in a variety of surgical indications. In this study the efficacy of PuraStat in reducing delayed bleeding following duodenal endoscopic mucosal resection (EMR) will be assessed. PuraStat will be applied to the EMR defect after the resection. The presence of active bleeding or high risk stigma of bleeding will be observed on an esophagogastroduodenoscopy (EGD) performed 1 day after the duodenal EMR. Furthermore the presence of clinical signs of delayed bleeding, other adverse events and the feasibility of PuraStat application will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Duodenal non-ampullary mucosal lesion ≥ 10 mm\n* ≥ 18y of age\n* Informed consent obtained\n\nExclusion Criteria:\n\n* Ampulloma\n* Submucosal lesion\n* Lesion \\< 10 mm\n* \\>1 lesion resected\n* Active use of anticoagulant or antithrombotic medication other than aspirin\n* Known clotting disorder\n* Inability to give informed consent\n* \\< 18y of age'}, 'identificationModule': {'nctId': 'NCT04629768', 'briefTitle': 'Purastat Prevention Delayed Bleeding Duodenum', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'A Study to Evaluate the Effectiveness of Purastat® in the Prevention of Delayed Bleeding After EMR of Non-ampullary Duodenal Lesions', 'orgStudyIdInfo': {'id': 'S63851'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Duodenal EMR + PuraStat', 'description': 'PuraStat will be applied to the defect after duodenal EMR of the lesion', 'interventionNames': ['Device: PuraStat']}], 'interventions': [{'name': 'PuraStat', 'type': 'DEVICE', 'description': 'Purastat is applied to the EMR defect', 'armGroupLabels': ['Duodenal EMR + PuraStat']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Raf Bisschops, MD PhD', 'role': 'CONTACT', 'email': 'raf.bisschops@uzleuven.be', 'phone': '+3216342161'}, {'name': 'Ingrid Demedts, MD PhD', 'role': 'CONTACT', 'email': 'ingrid.demedts@uzleuven.be', 'phone': '+3216345518'}, {'name': 'Raf Bisschops, MD PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ingrid Demedts, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospitals Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'centralContacts': [{'name': 'Raf Bisschops', 'role': 'CONTACT', 'email': 'raf.bisschops@uzleuven.be', 'phone': '+3216342161'}, {'name': 'Ingrid Demedts', 'role': 'CONTACT', 'email': 'ingrid.demedts@uzleuven.be', 'phone': '+3216345518'}], 'overallOfficials': [{'name': 'Ingrid Demedts', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UZ Leuven'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prof. Dr. Raf Bisschops', 'class': 'OTHER'}, 'collaborators': [{'name': '3-D Matrix Europe SAS', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical professor', 'investigatorFullName': 'Prof. Dr. Raf Bisschops', 'investigatorAffiliation': 'Universitaire Ziekenhuizen KU Leuven'}}}}