Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-29 @ 3:10 PM
Study NCT ID:
NCT06789406
Status:
RECRUITING
Last Update Posted:
2025-12-23
First Post:
2025-01-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PMCF Study of the Axonics SNM System Model 5101 (R20)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053202', 'term': 'Urinary Incontinence, Urge'}, {'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}], 'ancestors': [{'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 55}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2031-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-19', 'studyFirstSubmitDate': '2025-01-17', 'studyFirstSubmitQcDate': '2025-01-17', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Performance/Effectiveness - Improvement in Qualify of Life scoring (OAB)', 'timeFrame': '3 months', 'description': 'To demonstrate an improvement in Overactive Bladder Quality of Life using the International Consultation of Incontinence Questionnaire Overactive Bladder Qualify of Life (ICIQ-OABqol): questions in each subscale are scored by a summed range of 0 to 100, with a higher score indicating better quality of life. Overall score ≥ 10 points from baseline to follow-up is indicative of a clinically meaningful improvement.'}, {'measure': 'Adverse event reporting (Safety)', 'timeFrame': '3 months', 'description': 'Device related, procedure-related and all serious adverse events'}], 'secondaryOutcomes': [{'measure': 'Performance/Effectiveness - Improvement in Qualify of Life scoring (OAB)', 'timeFrame': '12 months', 'description': 'To demonstrate an improvement in Overactive Bladder Quality of Life using the International Consultation of Incontinence Questionnaire Overactive Bladder Qualify of Life (ICIQ-OABqol): questions in each subscale are scored by a summed range of 0 to 100, with a higher score indicating better quality of life. Overall score ≥ 10 points from baseline to follow-up is indicative of a clinically meaningful improvement.'}, {'measure': 'Performance/Effectiveness - Improvement in Qualify of Life scoring (FI)', 'timeFrame': '12 months', 'description': 'Cleveland Clinic Florida - Fecal Incontinence Score (CCF-FIS): scores range from 0 for full continence to 20 for complete incontinence. A higher score is indicative of the severity of fecal incontinence. Assessed if participant had a score of ≥6 at baseline.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Urinary Urge Incontinence (UUI)', 'Urinary Frequency (UF)', 'Overactive Bladder (OAB)']}, 'descriptionModule': {'briefSummary': 'Post-market clinical follow-up for continued assessment of safety and performance to confirm long-term outcomes of the Axonics SNM System INS Model 5101.', 'detailedDescription': 'This post-market clinical follow-up (PMCF) is conducted to assess the continued safety, device performance, and clinical benefit of the rechargeable Axonics SNM System INS Model 5101 also referred to as R20.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18 years or older\n2. Primary indication of OAB (urinary urgency incontinence (UUI) / urinary frequency (UF) who are not candidates for, or who have failed conservative treatment\n3. Willing and capable to provide written consent and agrees to comply with specified evaluations at clinical centers for all follow-up assessments\n\nExclusion Criteria:\n\n1. Any significant medical condition that is likely to interfere with procedures, device operation, or likely to confound evaluation of endpoints (i.e., neurological conditions such as multiple sclerosis)\n2. Any psychiatric or personality disorder that is likely to interfere with procedures at the discretion of the participating physician; this may include poor understanding or compliance with requirements\n3. Previously underwent an external sacral neuromodulation SNM trial and was deemed a non-responder or was previously implanted with a sacral neuromodulation device and did not get therapeutic benefit (a non-responder)\n4. History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone\n5. A female who is breastfeeding\n6. A female with a positive urine pregnancy test'}, 'identificationModule': {'nctId': 'NCT06789406', 'briefTitle': 'PMCF Study of the Axonics SNM System Model 5101 (R20)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Axonics, Inc.'}, 'officialTitle': 'Post-Market Clinical Follow-up Study of the Axonics SNM System Model 5101 (R20)', 'orgStudyIdInfo': {'id': '105-0104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Overactive Bladder', 'description': 'Participants with the Axonics SNM System Model 5101 and followed up regarding their overactive bladder symptoms.', 'interventionNames': ['Device: Axonics SNM System INS Model 5101 (R20)']}], 'interventions': [{'name': 'Axonics SNM System INS Model 5101 (R20)', 'type': 'DEVICE', 'description': "Participants treated with the rechargeable Axonics SNM System Model 5101 also referred to as R20. Commercial devices used in this study are within their intended use as described in each geography's approved instructions for use.", 'armGroupLabels': ['Overactive Bladder']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rowena Shi', 'role': 'CONTACT'}, {'name': 'Kimberly Kenton, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': 'BD96RJ', 'city': 'Bradford', 'state': 'West Yorkshire', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Karen Regan', 'role': 'CONTACT'}, {'name': 'Stephen Cox', 'role': 'CONTACT'}, {'name': 'Elizabeth Kidger, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Bradford Royal Infirmary', 'geoPoint': {'lat': 53.79391, 'lon': -1.75206}}, {'zip': 'WF1 4DG', 'city': 'Wakefield', 'state': 'West Yorkshire', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Toyin Familade', 'role': 'CONTACT'}, {'name': 'Ased Ali, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Pinderfields Hospital', 'geoPoint': {'lat': 53.68331, 'lon': -1.49768}}, {'zip': 'W1G 8PH', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Nadia Malabi', 'role': 'CONTACT'}, {'name': 'Mahreen Pakzad, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University College London Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Anna Selverian', 'role': 'CONTACT', 'email': 'anna.selverian@bsci.com', 'phone': '(949) 396-6322'}, {'name': 'Erum Shaikh', 'role': 'CONTACT', 'email': 'Erum.Shaikh@bsci.com', 'phone': '(949) 396-6322'}], 'overallOfficials': [{'name': 'Mahreen Pakzad, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University College London Hospitals'}, {'name': 'Gita Ghadimi, OD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Boston Scientific Corporation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Axonics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}