Ignite Creation Date:
2025-12-25 @ 12:46 AM
Ignite Modification Date:
2025-12-25 @ 10:59 PM
Study NCT ID:
NCT07191067
Status:
RECRUITING
Last Update Posted:
2025-10-17
First Post:
2025-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061208', 'term': 'Pulsed Radiofrequency Treatment'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D000078702', 'term': 'Radiofrequency Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-15', 'studyFirstSubmitDate': '2025-09-08', 'studyFirstSubmitQcDate': '2025-09-20', 'lastUpdatePostDateStruct': {'date': '2025-10-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Worst Pain at Day 10', 'timeFrame': '10 days post-TKA', 'description': 'The worst pain felt by each subject at day 10 after the TKA procedure (as measured by question 3 on the BPI)'}], 'secondaryOutcomes': [{'measure': 'Total morphine equivalents used', 'timeFrame': '5 days post-TKA', 'description': 'Total morphine equivalents used cumulatively through Day 5'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'Multi-center, randomized, blinded, sham-controlled study to determin the safety and efficacy of the NOVABLOC system on post-operative pain in patients undergoing TKA procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or non-pregnant females age ≥ 21 years of age;\n2. Has an underlying diagnosis of osteoarthritis indicated for a primary unilateral TKA according to established treatment guidelines;\n3. Able and willing to provide and document informed consent and Authorization for Release of Protected Health Information (PHI);\n4. Able and willing to comply with all trial tests, procedures, assessments, and follow-up visits for up to 45 days.\n5. Able to read and understand instructions and information presented in English.\n\nExclusion Criteria:\n\n1. Chronic opioid use (average ≥ 30 oral morphine equivalents / day) ≤ thirty (30) days of the TKA procedure;\n2. Extended-release or long-acting opioid (e.g. buprenorphine, Morphine ER, etc.) use ≤ thirty (30) days of the TKA procedure;\n3. History of substance abuse or misuse;\n4. History of significant cardiac disease (e.g. ejection fraction ≤ 50%; coronary intervention ≤ six (6) months; significant valvular abnormalities);\n5. Prior radiofrequency ablation or cryotherapy for pain on the operative knee;\n6. Prior TKA on the operative knee;\n7. BMI \\> 40;\n8. History of neurological, neuromuscular or neuropathic disease that would confound the study results, including chronic pain conditions;\n9. Have an active implanted biomedical device (such as cardiac pacemaker, insulin pump, pain stimulator, implantable cardioverter defibrillator) or cochlear \\[ear\\] stimulator);\n10. History of hip or knee dislocation or bone fractures on the operative leg;\n11. Sepsis or systemic infectious illness; local infection of skin or subcutaneous tissues where procedural access is required including thigh, hip or groin;\n12. Concomitant medical or psychiatric illness that could compromise evaluation or treatment, including anxiety (GAD-7 score \\>10) or depression (PHQ-9 score \\>15);\n13. Pregnant, actively planning a pregnancy or breast-feeding a child;\n14. Uncontrolled diabetes (A1C \\> 7.5%);\n15. History of bleeding disorder;\n16. Participating in another clinical trial/investigation within 45 days prior to signing informed consent.'}, 'identificationModule': {'nctId': 'NCT07191067', 'acronym': 'NOVABLOC TKA', 'briefTitle': 'Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty', 'organization': {'class': 'INDUSTRY', 'fullName': 'Synaptrix, Inc.'}, 'officialTitle': 'A Multi-Center Two-Arm, Randomized, Blinded, Sham-Controlled Trial to Determine the Safety and Efficacy of the NOVABLOC System on Postoperative Pain, Functional Recovery and Opioid Use in Patients Undergoing Primary Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': '1-25-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'NOVABLOC Stimulation', 'description': 'Subjects will receive NOVABLOC stimulation prior to their TKA', 'interventionNames': ['Device: Pulsed radiofrequency']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Stimulation', 'description': 'Subject will receive sham non-therapeutic stimulation', 'interventionNames': ['Device: Non-therapeutic stimulation']}], 'interventions': [{'name': 'Pulsed radiofrequency', 'type': 'DEVICE', 'description': 'Pulsed radiofrequency will be applied to the femoral and sciatic nerves prior to TKA.', 'armGroupLabels': ['NOVABLOC Stimulation']}, {'name': 'Non-therapeutic stimulation', 'type': 'DEVICE', 'description': 'Electrical square wave stimulation performed to mimic the duration of the active arm and mimic the procedure for blinding purposes.', 'armGroupLabels': ['Sham Stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36526', 'city': 'Daphne', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Natalia Alexeeva, PhD', 'role': 'CONTACT', 'email': 'natalex7230@outlook.com', 'phone': '315-395-3300'}, {'name': 'Daniel Matthews, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Alabama Orthopedic Sports Medicine & Baldwin County Surgery Center', 'geoPoint': {'lat': 30.60353, 'lon': -87.9036}}], 'centralContacts': [{'name': 'Daniel Guerrero', 'role': 'CONTACT', 'email': 'dan.guerrero@synaptrix.net', 'phone': '612-227-1483'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Synaptrix, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}