Ignite Creation Date:
2025-12-24 @ 4:42 PM
Ignite Modification Date:
2026-03-27 @ 12:58 AM
Study NCT ID:
NCT03186066
Status:
COMPLETED
Last Update Posted:
2024-03-12
First Post:
2017-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endoscopic Treatment of the Buried Bumper Syndrome: Comparison of the Flamingo Device Versus Standard Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-04-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-07', 'studyFirstSubmitDate': '2017-06-11', 'studyFirstSubmitQcDate': '2017-06-11', 'lastUpdatePostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time for Removal of PEG', 'timeFrame': 'Assessed at day 1 (day of intervention)'}], 'secondaryOutcomes': [{'measure': 'Success rate', 'timeFrame': 'Assessed at day 1'}, {'measure': 'Complications', 'timeFrame': 'Assessed during follow-up for up to ten days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Buried Bumper Syndrome']}, 'referencesModule': {'references': [{'pmid': '37543062', 'type': 'DERIVED', 'citation': 'Wannhoff A, Kullmer A, Albers D, Fahndrich M, Ganten T, Wettstein M, Meier B, Schumacher B, Schmidt A, Caca K. Prospective randomized controlled trial comparing a novel and dedicated device with conventional endoscopic techniques for the treatment of buried bumper syndrome (with video). Gastrointest Endosc. 2024 Jan;99(1):23-30.e1. doi: 10.1016/j.gie.2023.07.048. Epub 2023 Aug 3.'}]}, 'descriptionModule': {'briefSummary': 'Percutaneous endoscopic gastrostomy (PEG) is a method for nutrition delivery for patients with insufficient oral intake. A rare but severe complication of PEG is the Buried Bumper Syndrome (BBS). In BBS the internal fixation device of the PEG migrates along the stoma chanel. The internal fixation disc becomes covered by gastric mucosa, which causes loss of patency, fixation of the PEG and possible leakage around the PEG.\n\nBBS can be treated endoscopically by dissecting the overgrowing tissue with endoscopic submucosal dissection (ESD) knifes. A new and alternative approach is the use of the Flamingo device, which is inserted over the PEG and then is used to radially dissect the overgrowing tissue with a cutting wire.\n\nIn this study both methods, the standard method using an ESD knife and the Flamingo device, are compared in a randomized controlled open-label trial. Primary endpoint is the time needed for PEG removal.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Endoscopy proven Buried Bumper Syndrome\n* PEG or Jet-PEG\n\nExclusion Criteria:\n\n* Major Coagulation disorder\n* Percutaneous endoscopic jejunostomy or use of a ballon fixed device'}, 'identificationModule': {'nctId': 'NCT03186066', 'acronym': 'ESCAPE', 'briefTitle': 'Endoscopic Treatment of the Buried Bumper Syndrome: Comparison of the Flamingo Device Versus Standard Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Kliniken Ludwigsburg-Bietigheim gGmbH'}, 'officialTitle': 'A Prospective Randomized Controlled Multicenter Trial for Evaluation of the Flamingo Device in Endoscopic Treatment of the Buried Bumper Syndrome.', 'orgStudyIdInfo': {'id': 'ESCAPE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Therapy', 'description': 'Buried Bumper Syndrome is treated by endoscopically dissecting the overgrown tissue with an endoscopic submucosal dissection knife.', 'interventionNames': ['Procedure: Standard Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Flamingo Device', 'description': 'The Flamingo device is used for treatment of Buried Bumper Syndrome.', 'interventionNames': ['Device: Flamingo Device']}], 'interventions': [{'name': 'Flamingo Device', 'type': 'DEVICE', 'description': 'Endoscopic Treatment of Buried Bumper Syndrome with the Flamingo Device', 'armGroupLabels': ['Flamingo Device']}, {'name': 'Standard Therapy', 'type': 'PROCEDURE', 'description': 'Endoscopic Treatment of Buried Bumper Syndrome with an endoscopic submucosal dissection knife', 'armGroupLabels': ['Standard Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71640', 'city': 'Ludwigsburg', 'country': 'Germany', 'facility': 'Klinikum Ludwigsburg', 'geoPoint': {'lat': 48.89731, 'lon': 9.19161}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kliniken Ludwigsburg-Bietigheim gGmbH', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}