Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2026-02-24 @ 5:06 AM
Study NCT ID:
NCT04664868
Status:
COMPLETED
Last Update Posted:
2020-12-11
First Post:
2020-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SphinkeeperTM Procedure for Treating Severe Faecal Incontinence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004688', 'term': 'Encopresis'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019960', 'term': 'Elimination Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-07', 'studyFirstSubmitDate': '2020-11-30', 'studyFirstSubmitQcDate': '2020-12-07', 'lastUpdatePostDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Faecal incontinence assessment', 'timeFrame': 'six months', 'description': 'Episodes and number of faecal incomtinence and stool form with faecal incontinence were assessed using the Vaizey incontinence score (range 0-22, higher numbers mean severe incontinence forms)'}], 'secondaryOutcomes': [{'measure': 'Psychological und physical well-being', 'timeFrame': 'six months', 'description': 'The Psychological und physical well-being before and after implantation of Sphinkeeper was assessed using the SF12 standardized questionnaire (range 0-100; higher scores= Better quality of life)'}, {'measure': 'Migration of Sphinkeeper prostheses', 'timeFrame': 'six months', 'description': 'The Migration of Sphinkeeper prostheses were analyzed using endoanal ultrasound one and six months after implantation. The prostheses will be categorized by their position in relation to the anal canal axis. (Grade of rotation to the anal canal axis)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Faecal Incontinence']}, 'descriptionModule': {'briefSummary': 'Patients, aged 18 - 90 years, undergoing sphinkeeper operation at the Department of General Surgery at the Medical University of Vienna are enrolled into our study. Primary endpoints is the functional outcome as well as movement, migration and extrusion of sphinkeeper prostheses after implantation by endoluminal ultrasound and manometrical examination.', 'detailedDescription': 'The Sphinkeeper™ implantation for fecal incontinence is a novel surgical procedure with limited data on its clinical efficacy. Therefore, we aimed to assess the functional outcome following Sphinkeeper™ surgery in patients with refractory FI.\n\nPatients with FI, who met the inclusion criteria were enrolled to our study and received Sphinkeeper™ implantation. Functional outcome and quality of life was evaluated by standard questionnaires before and after surgery. In the routine check-up patients received endoanal ultrasound and anorectal manometry.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Candidates for sphinkeeper operations due to fecal incontinence will be enrolled in this study.', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18 - 90 years, undergoing sphinkeeper operation at the Department of General Surgery, Medical University of Vienna\n* Ability and willingness to understand and comply with study interventions and restrictions.\n* Voluntarily signed informed consent after full explanation of the study to the participant.\n\nExclusion Criteria:\n\n* Any physical or mental disorder, which could interfere with the participant's safety during the clinical trial or with the study objectives\n* Inability to communicate well with the investigator due to language problems or reduced mental development\n* Inability or unwillingness to give written informed consent"}, 'identificationModule': {'nctId': 'NCT04664868', 'briefTitle': 'SphinkeeperTM Procedure for Treating Severe Faecal Incontinence', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'SphinkeeperTM Procedure for Treating Severe Faecal Incontinence', 'orgStudyIdInfo': {'id': '2338/2019'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Sphinkeeper™', 'type': 'PROCEDURE', 'description': 'Sphinkeeper™ prostheses are self-expandable solid prostheses, made of inert Hyexpan (polyacrylonitrile) and are inserted into the intersphincteric anal groove.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Stefan Riss, Prof.MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Medical University of Vienna, Head of Pelvic Floor surgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD can be shared just in anonymised form in case of an ethical agreement with other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.med.univ., Research Fellow', 'investigatorFullName': 'Dr. Christopher Dawoud', 'investigatorAffiliation': 'Medical University of Vienna'}}}}