Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2025-12-29 @ 4:31 PM
Study NCT ID:
NCT01337206
Status:
COMPLETED
Last Update Posted:
2015-02-06
First Post:
2011-04-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SX ELLA Esophageal Degradable BD Stent System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004940', 'term': 'Esophageal Stenosis'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}], 'ancestors': [{'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015607', 'term': 'Stents'}], 'ancestors': [{'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-05', 'studyFirstSubmitDate': '2011-04-13', 'studyFirstSubmitQcDate': '2011-04-15', 'lastUpdatePostDateStruct': {'date': '2015-02-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The average number of dilations per patient within 3 months / 6 months following placement of an ELLA stent', 'timeFrame': '3 - 6 months'}], 'secondaryOutcomes': [{'measure': 'Number of patients remaining dysphagia and stricture free within 6 and 12 months after inclusion', 'timeFrame': '6 - 12 months'}, {'measure': 'Time to recurrent significant dysphagia', 'timeFrame': '6 - 12 months'}, {'measure': 'Time to dilation of recurrent stricture', 'timeFrame': '6 - 12 months'}, {'measure': '6 months and 12 months incidence of repeat dilation', 'timeFrame': '6 - 12 months'}, {'measure': 'Serious and minor adverse events with possible or likely relation to the study Intervention', 'timeFrame': '6 - 12 months'}, {'measure': 'Direct medicals costs: procedures, secondary interventions', 'timeFrame': '6 - 12 months'}, {'measure': 'Quality of Life', 'timeFrame': '6 - 12 months'}, {'measure': 'Technical success', 'timeFrame': '6 - 12 months', 'description': 'Observing proper deployment and placement of stent using endoscopic and radiographic imaging.'}, {'measure': 'Assessment of presence of gold markers within the region of the esophagus at 3 months, if possible', 'timeFrame': '6 - 12 months', 'description': 'Assessment of presence of gold markers within the region of the esophagus at 3 months, using radiographic imaging, if possible, to check for remaining sections of stent that have not yet degraded.'}]}, 'conditionsModule': {'keywords': ['Esophageal Stenosis', 'Esopageal Strictures', 'Esophageal Dysphagia'], 'conditions': ['Benign Esophageal Lesions']}, 'referencesModule': {'references': [{'pmid': '29883979', 'type': 'DERIVED', 'citation': "Walter D, van den Berg MW, Hirdes MM, Vleggaar FP, Repici A, Deprez PH, Viedma BL, Lovat LB, Weusten BL, Bisschops R, Haidry R, Ferrara E, Sanborn KJ, O'Leary EE, van Hooft JE, Siersema PD. Dilation or biodegradable stent placement for recurrent benign esophageal strictures: a randomized controlled trial. Endoscopy. 2018 Dec;50(12):1146-1155. doi: 10.1055/a-0602-4169. Epub 2018 Jun 8."}]}, 'descriptionModule': {'briefSummary': 'The SX-ELLA Stent Esophageal Degradable BD (BD Stent) is designed for dilation of benign esophageal lesions, namely: (1) stenosis (peptic, anastomotic or caustic) refractory to standard therapy, (2) achalasia refractory to standard therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A recurrent benign esophageal stricture due to all causes (surgery, radiation therapy, corrosive ingestion, peptic injury, PDT, or other ablative therapy)\n\nExclusion Criteria:\n\n* Patient \\< 18 years old\n* Patient is unwilling or unable to sign and date the informed consent\n* Patient is unwilling or unable to comply with the follow-up schedule\n* Patient is pregnant, breast-feeding, or planning to become pregnant in the next 12 months\n* Patient is simultaneously participating in another drug or device study or the patient has completed the follow-up phase for the primary objective of any previous study less than 30 days prior to enrollment in this study\n* Patient with a life expectancy \\< 12 months'}, 'identificationModule': {'nctId': 'NCT01337206', 'acronym': 'DESTINY', 'briefTitle': 'SX ELLA Esophageal Degradable BD Stent System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cook Group Incorporated'}, 'officialTitle': 'Evaluation of the Effectiveness of the SX ELLA Esophageal Degradable BD (BD Stent) Stent System', 'orgStudyIdInfo': {'id': '09-024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stenting Arm', 'description': 'Stenting Arm', 'interventionNames': ['Device: Stenting with ELLA Biodegradable stent']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dilation Arm', 'description': 'Dilation Arm', 'interventionNames': ['Procedure: Standard Dilations']}], 'interventions': [{'name': 'Stenting with ELLA Biodegradable stent', 'type': 'DEVICE', 'otherNames': ['Esophageal Stenting'], 'description': 'Treating benign esophageal lesions with the placement of a degradable stent', 'armGroupLabels': ['Stenting Arm']}, {'name': 'Standard Dilations', 'type': 'PROCEDURE', 'otherNames': ['Bougie Dilation, Balloon Dilation'], 'description': 'Treating benign esophageal lesions with standard dilation therapy', 'armGroupLabels': ['Dilation Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Clinique Universitaire Saint Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'University Hospitals Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '20089', 'city': 'Milan', 'country': 'Italy', 'facility': 'IRCCS Istituto Clinico Humanitas', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '22700', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Academic Medical Center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Nieuwegein', 'country': 'Netherlands', 'facility': 'St. Antonius Hospital', 'geoPoint': {'lat': 52.02917, 'lon': 5.08056}}, {'zip': '3508', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'University Medical Center Utrech', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'zip': '13005', 'city': 'Ciudad Real', 'country': 'Spain', 'facility': 'Hospital General Universitario de Ciudad Real', 'geoPoint': {'lat': 38.98626, 'lon': -3.92907}}, {'zip': 'NW1 2PG', 'city': 'London', 'country': 'United Kingdom', 'facility': 'University College of London Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Peter D. Siersema, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Utrech'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cook Group Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}