Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2025-12-26 @ 5:13 PM
Study NCT ID:
NCT03767166
Status:
COMPLETED
Last Update Posted:
2021-03-18
First Post:
2018-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Archimedes Biodegradable Biliary and Pancreatic Stents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-17', 'studyFirstSubmitDate': '2018-11-20', 'studyFirstSubmitQcDate': '2018-12-04', 'lastUpdatePostDateStruct': {'date': '2021-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biodegradation time', 'timeFrame': '24 Months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pancreatic Diseases']}, 'referencesModule': {'references': [{'pmid': '32145287', 'type': 'DERIVED', 'citation': 'Anderloni A, Fugazza A, Maroni L, Ormando V, Maselli R, Carrara S, Cappello A, Mangiavillano B, Omodei P, Preatoni P, Galtieri PA, Pellegatta G, Repici A. New biliary and pancreatic biodegradable stent placement: a single-center, prospective, pilot study (with video). Gastrointest Endosc. 2020 Aug;92(2):405-411. doi: 10.1016/j.gie.2020.02.049. Epub 2020 Mar 5.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective, phase II, single-centre, non-randomised, single-arm study, enrolling patients with benign and malignant bilio-pancreatic diseases with an indication to biliary or pancreatic plastic stent positioning during ERCP.\n\nOn procedure day, the study team will confirm that the patient meets all the inclusion criteria and none of the exclusion criteria.\n\nThe patient will undergo the ABS insertion and monitored and follow-up accordingly to biodegration variant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with benign and malignant bilio-pancreatic diseases with an indication to biliary or pancreatic plastic stent positioning during ERCP.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with an indication to position one ore more biliary plastic stents during ERCP\n* Patients with an indication to position a pancreatic plastic stent during ERCP\n\nExclusion Criteria:\n\n* Age \\< 18 y\n* Life expectancy \\< 1 m,\n* Inability to pass a guidewire through stricture\n* Contra-indication for endoscopy or interventional radiology\n* Presence of partial gastric resection\n* Unsigned informing consent form, ICF\n* Pregnancy\n* Pseudo Klatskin tumors (metastases in the liver hilum) and gallbladder carcinoma'}, 'identificationModule': {'nctId': 'NCT03767166', 'acronym': 'ARCHIMEDES', 'briefTitle': 'The Archimedes Biodegradable Biliary and Pancreatic Stents', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Clinico Humanitas'}, 'officialTitle': 'A Prospective, Single Arm Study to Evaluate the Feasibility of the Archimedes Biodegradable Biliary and Pancreatic Stents Placement', 'orgStudyIdInfo': {'id': '2275'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Biodegradable biliary and pancreatic stents placement', 'type': 'DEVICE', 'description': 'Biodegradable biliary and pancreatic stents placement'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20089', 'city': 'Rozzano', 'state': 'Milano', 'country': 'Italy', 'facility': 'Endoscopy Unit, Humanitas Research Hospital', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Clinico Humanitas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}