Ignite Creation Date:
2025-12-24 @ 12:53 PM
Ignite Modification Date:
2025-12-25 @ 12:17 PM
Study NCT ID:
NCT05721261
Status:
RECRUITING
Last Update Posted:
2025-08-08
First Post:
2023-02-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Regeneration of Acutely Injured Nerves With Temporary Electrical Stimulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-05', 'studyFirstSubmitDate': '2023-02-01', 'studyFirstSubmitQcDate': '2023-02-01', 'lastUpdatePostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensory recovery', 'timeFrame': '6 months'}, {'measure': 'Cumulative incidence of adverse events', 'timeFrame': '6 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nerve Injury']}, 'descriptionModule': {'briefSummary': 'A novel temporary peripheral nerve stimulation system that delivers a single dose of electrical stimulation therapy for 1 hour will be evaluated for safety and effectiveness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Peripheral nerve injury\n\nExclusion criteria:\n\n* Peripheral neuropathy\n* Patients with any active implanted device'}, 'identificationModule': {'nctId': 'NCT05721261', 'acronym': 'REGAIN', 'briefTitle': 'Regeneration of Acutely Injured Nerves With Temporary Electrical Stimulation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Epineuron Technologies Inc.'}, 'officialTitle': 'Regeneration of Acutely Injured Nerves With Temporary Electrical Stimulation', 'orgStudyIdInfo': {'id': 'EPNR-CIP-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active treatment', 'interventionNames': ['Device: Temporary Peripheral Nerve Stimulation System']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham treatment', 'interventionNames': ['Device: Sham Temporary Peripheral Nerve Stimulation System']}], 'interventions': [{'name': 'Temporary Peripheral Nerve Stimulation System', 'type': 'DEVICE', 'description': 'Single use medical device. Therapy consists of single, 1 hour dose of electrical stimulation delivered proximal to injury site.', 'armGroupLabels': ['Active treatment']}, {'name': 'Sham Temporary Peripheral Nerve Stimulation System', 'type': 'DEVICE', 'description': 'Single use medical device. Sham treatment consists of single, 1 hour dose of sham stimulation.', 'armGroupLabels': ['Sham treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32608', 'city': 'Gainesville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ellen Satteson, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Tarek A El-Gammal, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jongmin Kim, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Florida Health', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Karan Desai, MD, FAAOS', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Justin Zumsteg, MD, FAAOS', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Orlando Health Jewett Orthopedic Institute', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '21218', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'The Curtis National Hand Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '17403', 'city': 'York', 'state': 'Pennsylvania', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'WellSpan Health', 'geoPoint': {'lat': 39.9626, 'lon': -76.72774}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'William Pientka II, MD, FAAOS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'John Peter Smith Hospital', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'city': 'Edmonton', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'K. Ming Chan, MD, FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Matthew Curran, MD, MSc, FRCSC', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jaret Olson, MD, FRCSC', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Michael Morhart, MSc, MD, FRCSC', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hollie Power, MD, FRCSC', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Adil Ladak, MD, MSc, FRCSC', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Alberta Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'city': 'Saint John', 'state': 'New Brunswick', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Alison Wong, MD, MSc, FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Saint John Regional Hospital', 'geoPoint': {'lat': 45.27076, 'lon': -66.05616}}, {'city': 'Hamilton', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'James Bain, MD, MSc, FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Genevieve Dostaler, MD, MHA, FRCSC', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Brian Hyosuk Chin, MD, MSc, FRCSC', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hamilton General Hospital', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'city': 'Hamilton', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Carolyn Levis, MD, MSc, FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "St. Joseph's Healthcare Hamilton", 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'city': 'London', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Stahs Pripotnev, MD, FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Roth | McFarlane Hand & Upper Limb Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Yasser El-Sheikh, MD, FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'North York General Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Sharon Kim, MD, FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Brian Hong, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Trillium Health Partners', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Tracy Cameron, PhD', 'role': 'CONTACT', 'email': 'tcameron@epineurontech.com', 'phone': '905-206-0466'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Epineuron Technologies Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}