Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT04662905
Status:
RECRUITING
Last Update Posted:
2025-05-13
First Post:
2020-11-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Novel Treatment Delivery of ECAP-controlled Closed-loop SCS for Chronic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062187', 'term': 'Spinal Cord Stimulation'}, {'id': 'D016503', 'term': 'Drug Delivery Systems'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D004358', 'term': 'Drug Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-12', 'studyFirstSubmitDate': '2020-11-30', 'studyFirstSubmitQcDate': '2020-12-04', 'lastUpdatePostDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Evoke Compound Action Potentials (ECAPs) as measured by the Evoke SCS System', 'timeFrame': 'Through study completion, up to 2 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test and evaluate novel treatment delivery of ECAP-controlled closed loop SCS through the incorporation of new software and/or hardware features for patients with the Evoke System.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Subject has undergone trial implant or is planning to be implanted with the Evoke System within its approved indication.\n* 2\\. Subject is willing and capable of giving informed consent and able to comply with study-related requirements.\n\nExclusion Criteria:\n\nN/A'}, 'identificationModule': {'nctId': 'NCT04662905', 'acronym': 'Freshwater', 'briefTitle': 'Novel Treatment Delivery of ECAP-controlled Closed-loop SCS for Chronic Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Saluda Medical Pty Ltd'}, 'officialTitle': 'A Prospective, Multicentre, Single-arm Feasibility Study Examining Novel Treatment Delivery of the Evoke Spinal Cord Stimulator (SCS) System to Treat Patients With Chronic Pain of the Trunk and/or Limbs', 'orgStudyIdInfo': {'id': 'CLIN-PCL-007873'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ECAP-controlled, closed-loop SCS', 'description': 'Spinal cord stimulation that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude', 'interventionNames': ['Device: Evoke Spinal Cord Stimulation (SCS) System']}], 'interventions': [{'name': 'Evoke Spinal Cord Stimulation (SCS) System', 'type': 'DEVICE', 'description': 'ECAP-controlled, closed-loop SCS', 'armGroupLabels': ['ECAP-controlled, closed-loop SCS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2605', 'city': 'Garran', 'state': 'Australian Capital Territory', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'ACT Pain Centre', 'geoPoint': {'lat': -35.34206, 'lon': 149.10846}}, {'zip': '2153', 'city': 'Bella Vista', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Sydney Pain Specialists', 'geoPoint': {'lat': -33.74127, 'lon': 150.95456}}, {'zip': '2292', 'city': 'Broadmeadow', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Genesis Research Services', 'geoPoint': {'lat': -32.92371, 'lon': 151.72849}}, {'zip': '2290', 'city': 'Charlestown', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Northern Integrated Pain Management', 'geoPoint': {'lat': -32.96828, 'lon': 151.69318}}, {'zip': '2220', 'city': 'Hurstville', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Australian Medical Research', 'geoPoint': {'lat': -33.9677, 'lon': 151.10149}}, {'zip': '2042', 'city': 'Newtown', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Inner West Pain Centre', 'geoPoint': {'lat': -33.89835, 'lon': 151.17754}}, {'zip': '2065', 'city': 'Saint Leonards', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Royal North Shore Hospital'}, {'zip': '2065', 'city': 'St Leonards', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Northern Pain Centre', 'geoPoint': {'lat': -33.82344, 'lon': 151.19836}}, {'zip': '2000', 'city': 'Sydney', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'facility': "Women's Health & Research Institute of Australia", 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '2076', 'city': 'Wahroonga', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Sydney Pain Research Centre Pty Ltd', 'geoPoint': {'lat': -33.71816, 'lon': 151.11561}}, {'zip': '4066', 'city': 'Auchenflower', 'state': 'Queensland', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Interventus Pain Specialists', 'geoPoint': {'lat': -27.47443, 'lon': 152.99213}}, {'zip': '4000', 'city': 'Brisbane', 'state': 'Queensland', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Axxon Pain Medicine', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'zip': '4014', 'city': 'Brisbane', 'state': 'Queensland', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Total Pain Clinic', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'zip': '4006', 'city': 'Fortitude Valley', 'state': 'Queensland', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'QPAIN', 'geoPoint': {'lat': -27.45706, 'lon': 153.03178}}, {'zip': '4567', 'city': 'Noosa', 'state': 'Queensland', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Sunshine Coast Clinical Research', 'geoPoint': {'lat': -26.39433, 'lon': 153.0901}}, {'zip': '4573', 'city': 'Peregian Beach', 'state': 'Queensland', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Paul Frank Medical Services', 'geoPoint': {'lat': -26.481, 'lon': 153.096}}, {'zip': '5034', 'city': 'Wayville', 'state': 'South Australia', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'CerCare Pty Ltd', 'geoPoint': {'lat': -34.94468, 'lon': 138.59132}}, {'zip': '3168', 'city': 'Clayton', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Monash Clinical Research', 'geoPoint': {'lat': -37.91667, 'lon': 145.11667}}, {'zip': '3199', 'city': 'Frankston', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Frankston Pain Management', 'geoPoint': {'lat': -38.14458, 'lon': 145.12291}}, {'zip': '3220', 'city': 'Geelong', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Pain Matrix', 'geoPoint': {'lat': -38.14711, 'lon': 144.36069}}, {'zip': '3121', 'city': 'Richmond', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Melbourne Pain Specialists', 'geoPoint': {'lat': -37.81819, 'lon': 145.00176}}, {'zip': '3121', 'city': 'Richmond', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Pain Specialists Australia', 'geoPoint': {'lat': -37.81819, 'lon': 145.00176}}, {'zip': '6011', 'city': 'Cottesloe', 'state': 'Western Australia', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'PainCare Perth', 'geoPoint': {'lat': -31.99426, 'lon': 115.75816}}], 'centralContacts': [{'name': 'Director, Clinical Affairs', 'role': 'CONTACT', 'email': 'angela.leitner@saludamedical.com', 'phone': '16512084223'}], 'overallOfficials': [{'name': 'Angela M Leitner', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Saluda Medical Pty Ltd'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saluda Medical Pty Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}