Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-24 @ 5:00 PM
Study NCT ID:
NCT04007250
Status:
COMPLETED
Last Update Posted:
2019-07-26
First Post:
2019-06-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
FENIX™ Continence Restoration System Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005242', 'term': 'Fecal Incontinence'}, {'id': 'D004688', 'term': 'Encopresis'}], 'ancestors': [{'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'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': 94}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-24', 'studyFirstSubmitDate': '2019-06-27', 'studyFirstSubmitQcDate': '2019-07-02', 'lastUpdatePostDateStruct': {'date': '2019-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in fecal incontinence (FI) episodes', 'timeFrame': 'Evaluate at 6 months and then annually at 12 months through 60 months post implant', 'description': 'Proportion of participants with at least a 50% reduction in FI episodes per week'}, {'measure': 'Change in fecal incontinence days', 'timeFrame': 'Evaluate at 6 months and then annually at 12 months through 60 months post implant', 'description': 'Proportion of participants achieving at least 50% reduction in FI days per week and urgent episodes'}, {'measure': 'Adverse events related to the FENIX system', 'timeFrame': 'assessed up to last follow up [max 60 months]', 'description': 'From the time of implant and at each follow-up visit, safety will be evaluated by characterizing adverse events (AEs) related to the FENIX system and summarizing incidence rates. Serious device-related AEs will be summarized separately.'}, {'measure': 'Change in Fecal Incontinence Quality of Life: Fecal Incontinence Quality of Life (FIQOL) score.', 'timeFrame': 'Evaluate at 6 months and then annually at 12 months through 60 months post implant', 'description': 'Proportion of patients with improvement in Fecal Incontinence Quality of Life (FIQOL) score. The Fecal Incontinence Quality of Life Scale consists of 29 items divided into 4 scales:\n\n* Lifestyle (10 items)\n* Coping/Behavior (9 items)\n* Depression/Self Perception (7 items)\n* Embarrassment (3 items) Scales range from 1 to 5, scale scores are the average (mean) of all responses to all items in each scale. A lower score indicated a lower quality of life. The scales are not combined for a "composite" or total score but always presented individually.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Magnetic Anal Sphincter Augmentation', 'FENIX™ continence restoration system', 'Magnetic Anal Sphincter'], 'conditions': ['Fecal Incontinence', 'Faecal Incontinence']}, 'descriptionModule': {'briefSummary': 'The FENIX Registry is a multi-center, observational database designed to collect data regarding the FENIX™ Continence Restoration System in everyday clinical practice, evaluate the clinical course of patients from pre-operative assessment through five years post-surgery and Track and monitor effectiveness and safety through the use of a bowel diary, fecal incontinence quality-of-life measures and adverse event reporting. Up to 25 sites will participate in the Registry. Sites to enroll consecutive eligible patients into the Registry. Registry will enroll approximately 200 FENIX patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Chronic fecal incontinence patients who have failed or are not candidates for more conservative therapy.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals being treated with the FENIX™ Continence Restoration System\n* Individuals who have provided appropriate authorization per institutional policy and procedure to have clinical and health information collected for the FENIX Registry.\n* Individuals willing to complete a 14-day bowel diary, questionnaires and comply with all required follow-up.\n\nExclusion Criteria:\n\n* Known circumstances that would make it unlikely for an individual to complete the five-year follow-up (e.g. life expectancy \\<5 years)'}, 'identificationModule': {'nctId': 'NCT04007250', 'briefTitle': 'FENIX™ Continence Restoration System Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Torax Medical Incorporated'}, 'officialTitle': 'FENIX™ Continence Restoration System Registry', 'orgStudyIdInfo': {'id': '3422'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'FENIX participants', 'description': 'Individuals being treated with the FENIX™ Continence Restoration System.', 'interventionNames': ['Device: FENIX™ Continence Restoration System']}], 'interventions': [{'name': 'FENIX™ Continence Restoration System', 'type': 'DEVICE', 'otherNames': ['Magnetic anal sphincter augmentation'], 'description': 'The FENIX™ Continence Restoration System is indicated for use for the treatment of chronic fecal incontinence in patients who have failed or are not candidates for more conservative therapy. The FENIX™ System Implant is placed around the external anal sphincter to augment a weak anal sphincter and restore continence.\n\nThe FENIX™ System is comprised of the following components:\n\n* FENIX™ System Implant\n* FENIX™ System Anal Sphincter Sizing Tool The FENIX™ System Implant consists of a series of titanium beads with magnetic cores that are connected with independent titanium wires to form an annular shape. The attractive force of the magnetic beads is designed to provide additional strength to keep a weak anal sphincter closed.', 'armGroupLabels': ['FENIX participants']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nantes', 'country': 'France', 'facility': 'University Hospital of Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Essen', 'country': 'Germany', 'facility': 'Kliniken Essen-Mitte', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Torax Medical Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}