Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-25 @ 5:26 PM
Study NCT ID:
NCT06336304
Status:
RECRUITING
Last Update Posted:
2025-02-26
First Post:
2024-03-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
NXT Post-Market Clinical Follow-up
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}, {'id': 'D001750', 'term': 'Urinary Bladder, Neurogenic'}, {'id': 'D053202', 'term': 'Urinary Incontinence, Urge'}], 'ancestors': [{'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'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-24', 'studyFirstSubmitDate': '2024-03-21', 'studyFirstSubmitQcDate': '2024-03-21', 'lastUpdatePostDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess NXT system performance', 'timeFrame': '120 Minutes', 'description': 'Assess the proportion of affirmative responses to the question: did the NXT system successfully measure all necessary urodynamic parameters you required for this patient?'}, {'measure': 'Assess NXT system safety', 'timeFrame': '120 Minutes', 'description': 'The primary safety endpoint will be measured by recording the incidence of serious adverse events and adverse events.'}], 'secondaryOutcomes': [{'measure': 'Assess NXT system performance', 'timeFrame': '120 Minutes', 'description': 'Assess the proportion of affirmative responses to the question: Was the urodynamic study completed without any technical failure that prevented its completion?'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Urinary Incontinence', 'Urinary Obstruction', 'Urinary Bladder, Overactive', 'Urinary Bladder, Neurogenic', 'Urinary Incontinence, Urge']}, 'descriptionModule': {'briefSummary': 'NXT Urodynamics System Post-Market Clinical Follow-up Clinical Investigation to Confirm Ongoing Safety and Performance in Urodynamic Patient Sub-Populations', 'detailedDescription': 'The primary objective of this study is to confirm the safety and performance of NXT urodynamic system for the intended patient populations, medically indicated for urodynamic study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male, Female and Pediatric subjects who have been medically indicated for UDS testing.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients medically indicated for urodynamic study\n* Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements\n\nExclusion Criteria:\n\n* Patients or legally authorized representative with cognitive or psychiatric condition that interferes with or precludes direct and accurate communication regarding the study, giving informed consent or ability to complete the patient questionnaire\n* Patients with confirmed active bladder infections (not including patients with asymptotic bacteria)\n* Pregnant women\n* Patients with recent (less than 2 weeks) pelvic floor surgery\n* Requires use of suprapubic catheter'}, 'identificationModule': {'nctId': 'NCT06336304', 'briefTitle': 'NXT Post-Market Clinical Follow-up', 'organization': {'class': 'INDUSTRY', 'fullName': 'Laborie Medical Technologies Inc.'}, 'officialTitle': 'NXT Urodynamics System Post-Market Clinical Follow-up Clinical Investigation', 'orgStudyIdInfo': {'id': 'NXTPMCF-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pediatric', 'interventionNames': ['Diagnostic Test: Urodynamic procedure']}, {'label': 'Male Adult Obstructive', 'interventionNames': ['Diagnostic Test: Urodynamic procedure']}, {'label': 'Male Adult Incontinence and/or Overactive Bladder', 'interventionNames': ['Diagnostic Test: Urodynamic procedure']}, {'label': 'Female Adult Obstructive', 'interventionNames': ['Diagnostic Test: Urodynamic procedure']}, {'label': 'Female Adult Incontinence and/or Overactive Bladder', 'interventionNames': ['Diagnostic Test: Urodynamic procedure']}, {'label': 'Adults with Neurological Co-morbidities', 'interventionNames': ['Diagnostic Test: Urodynamic procedure']}], 'interventions': [{'name': 'Urodynamic procedure', 'type': 'DIAGNOSTIC_TEST', 'description': 'Urodynamic procedure', 'armGroupLabels': ['Adults with Neurological Co-morbidities', 'Female Adult Incontinence and/or Overactive Bladder', 'Female Adult Obstructive', 'Male Adult Incontinence and/or Overactive Bladder', 'Male Adult Obstructive', 'Pediatric']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21076', 'city': 'Hanover', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Barbara Kyei', 'role': 'CONTACT'}, {'name': 'Kaiser Robertson, MD', 'role': 'CONTACT'}], 'facility': 'Chesapeake Urology Hanover', 'geoPoint': {'lat': 39.19289, 'lon': -76.72414}}, {'zip': '21117', 'city': 'Owing Mills', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Seema Shahi', 'role': 'CONTACT'}, {'name': 'Laura Giusto, MD', 'role': 'CONTACT'}], 'facility': 'Chesapeake Urology Owing Mills'}, {'zip': '43212', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Maxwell Newton', 'role': 'CONTACT', 'email': 'maxwell.newton@osumc.edu', 'phone': '614-366-9561'}, {'name': 'Iryna Crescenze, MD', 'role': 'CONTACT'}], 'facility': 'Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '22903', 'city': 'Charlottesville', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Olusegun Adelaja', 'role': 'CONTACT', 'email': 'oba4e@virginia.edu', 'phone': '434-924-5783'}, {'name': 'Jacqueline Zillioux, MD', 'role': 'CONTACT'}], 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'centralContacts': [{'name': 'Kaitlyn Palm', 'role': 'CONTACT', 'email': 'rs.nxtpmcf@laborie.com', 'phone': '6128160068'}, {'name': 'Adele Campbell', 'role': 'CONTACT', 'email': 'rs.nxtpmcf@laborie.com', 'phone': '6032558251'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laborie Medical Technologies Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}