Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
Study NCT ID:
NCT07439666
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-02-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
NEUROCUPLE™ as an Opioid Alternative Following Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000080482', 'term': 'Enhanced Recovery After Surgery'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019990', 'term': 'Perioperative Care'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This will be a double-blinded randomized (1:1) placebo-controlled clinical trial to determine the feasibility and effectiveness of a 7-day application of the NEUROCUPLE device for pain relief and reduction of opioid refills after TKA. There is a placebo device (sham device without the captor array layer) that looks exactly like the active device, allowing for a true placebo-controlled randomized study.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 274}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-23', 'studyFirstSubmitDate': '2026-02-23', 'studyFirstSubmitQcDate': '2026-02-23', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain at Rest Using Numerical Rating Scale (NRS)', 'timeFrame': '24 hours post-surgery', 'description': 'Pain at rest during the first 24 hours after surgery will be assessed using a Numerical Rating Scale (NRS; 0 = no pain, 10 = worst pain) and compared between the NEUROCUPLE™ patch group and the placebo patch group. Higher scores indicate worse pain'}, {'measure': 'Opioid Consumption', 'timeFrame': 'at 24 hours post-surgery', 'description': 'Total opioid consumption, expressed in milligrams of morphine equivalents (MME), during the first 24 hours following surgery.\n\nOpioid use will be calculated using all available data sources, including in-hospital medication administration records and, when applicable, the state Prescription Drug Monitoring Program (PDMP).\n\nMME values will be compared between the NEUROCUPLE™ patch group and the placebo patch group. Lower MME values indicate reduced opioid requirements and may reflect improved postoperative pain control, while higher MME values suggest increased opioid use and potentially greater pain or slower recovery.'}], 'secondaryOutcomes': [{'measure': 'Pain Scores Using Numerical Rating Scale (NRS) at Rest and during Movement', 'timeFrame': 'Post-operative at Day 2 and Day 7', 'description': 'Pain will be assessed using a Numerical Rating Scale (0 = no pain, 10 = worst pain) at rest and during movement on postoperative Days 2 and 7. Higher scores indicate worse pain.'}, {'measure': 'Opioid Consumption', 'timeFrame': 'Postoperative Days 0-7', 'description': 'Total opioid consumption, expressed in milligrams of morphine equivalents (MME), will be recorded over the 7-day postoperative period.\n\nOpioid use will be calculated using all available data sources, including in-hospital medication administration records and the state Prescription Drug Monitoring Program (PDMP) when applicable.\n\nMME values will be compared between the NEUROCUPLE™ patch group and the placebo patch group. Lower MME values indicate reduced opioid requirements and may reflect improved postoperative pain control, whereas higher MME values suggest increased opioid use and potentially greater pain or slower recovery.'}, {'measure': 'Incidence of postoperative nausea and/or vomiting (yes/no)', 'timeFrame': 'Postoperative Days 0-7', 'description': 'Incidence and severity of postoperative nausea and vomiting will be recorded over the 7-day postoperative period as (yes/no) and compared between groups.'}, {'measure': 'Postoperative Length of Stay', 'timeFrame': 'From the date of surgery until hospital discharge (within the 7-day study period)', 'description': 'Length of hospital stay, defined as the number of days from the date of surgery to the date of hospital discharge, will be recorded and compared between groups.\n\nLower length of stay values indicate faster recovery, fewer complications, and earlier readiness for discharge. Higher length of stay values suggest slower recovery, increased complications, or higher postoperative symptom burden.'}, {'measure': 'Postoperative Adverse Events and Device-Related Side Effects', 'timeFrame': 'Postoperative Days 0-7', 'description': 'The incidence of postoperative adverse events, including any events determined to be related to the study device, will be recorded and compared between the treatment groups during the 7-day postoperative period.\n\nLower incidence rates indicate fewer complications and a more favorable safety profile, whereas higher incidence rates suggest increased complications, potential device-related issues, or a less favorable safety profile.'}, {'measure': 'Patient Satisfaction', 'timeFrame': 'at Post-operative Day 7', 'description': 'Patient satisfaction with recovery and device use will be assessed on postoperative Day 7 using standardized questionnaires. Scores range from 0 to 10, where 0 indicates the lowest level of satisfaction and 10 indicates the highest.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Total Knee Arthroplasty', 'Postoperative Pain', 'TKA', 'Opioid Use', 'Non opioid Pain Management', 'NEUROCUPLE Patch', 'Knee Replacement', 'Acute Postoperative Pain', 'Randomized Clinical Trial'], 'conditions': ['Total Knee Arthroplasty Postoperative Pain', 'Opioid Reduction After TKA']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if the NEUROCUPLE device can reduce pain and opioid use after primary unilateral total knee arthroplasty (TKA) in adults.\n\nThe main questions it aims to answer are:\n\n* Does the NEUROCUPLE device reduce postoperative pain at rest during the first 24 hours after TKA?\n* Does the NEUROCUPLE device reduce opioid consumption during the first 24 hours after TKA?\n\nResearchers will compare the NEUROCUPLE device to a placebo device (identical in appearance but inactive) to see if the device reduces pain and opioid use after surgery.\n\nParticipants will:\n\n* Apply the NEUROCUPLE device or placebo device for 7 days following surgery\n* Have their pain and opioid use monitored through clinical records and patient reporting\n* Report pain at rest and during movement on postoperative Days 2 and 7\n* Be assessed for nausea, vomiting, device-related side effects, length of hospital stay, and overall satisfaction'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>18 years of age\n* Scheduled for elective primary unilateral TKA\n\nExclusion Criteria:\n\n* Children (\\<18 yr.)\n* Pregnant women\n* Active alcoholism (defined as daily use of more than 1 liter of wine and /or 3 or more shots of hard liquor) or drug abuse (defined as daily use of illicit drugs)\n* Severe chronic pain condition that requires daily preoperative opioid dependence\n* Other concomitant surgery being performed in addition to TKA\n* Patients undergoing bilateral TKA\n* Patients undergoing knee replacement revision\n* Patients with limited mobility (in a wheelchair or requiring a walker)\n* Patients who are not returning home after surgery'}, 'identificationModule': {'nctId': 'NCT07439666', 'briefTitle': 'NEUROCUPLE™ as an Opioid Alternative Following Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'The Role of NEUROCUPLE™ as an Alternative to Opioids Following Total Knee Arthroplasty Patients', 'orgStudyIdInfo': {'id': 'STUDY25120065'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NEUROCUPLE™ Group', 'description': 'This arm of subjects will receive the active NEUROCUPLE™ patch to wear for 7 days following their TKA surgery.', 'interventionNames': ['Device: NEUROCUPLE™ Patch', 'Other: Enhanced Recovery After Surgery (ERAS) Standard of Care']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Group', 'description': 'This arm of subjects will receive the placebo (non-active, sham) patch to wear for 7 days following their TKA surgery.', 'interventionNames': ['Device: Sham patch', 'Other: Enhanced Recovery After Surgery (ERAS) Standard of Care']}], 'interventions': [{'name': 'NEUROCUPLE™ Patch', 'type': 'DEVICE', 'description': 'nCAP Medical has developed an effective, safe, non-opioid alternative, the NEUROCUPLE™ device, based on an innovative nanotechnology to reduce surgical pain and facilitate functional recovery while reducing opioid prescriptions, opioid-related adverse events and reducing the cost of care in millions of Americans undergoing TKA each year. The patch will be worn for 7-days', 'armGroupLabels': ['NEUROCUPLE™ Group']}, {'name': 'Sham patch', 'type': 'DEVICE', 'description': 'Non-active placebo patch visually identical to NEUROCUPLE™ worn for 7 days following total knee arthroplasty.', 'armGroupLabels': ['Sham Group']}, {'name': 'Enhanced Recovery After Surgery (ERAS) Standard of Care', 'type': 'OTHER', 'description': 'Participants in both arms will receive approved Enhanced Recovery After Surgery (ERAS) multimodal care, including preoperative education and optimization, intraoperative minimally invasive techniques and multimodal analgesia, and postoperative early mobilization, early nutrition, pain control, and monitoring for complications', 'armGroupLabels': ['NEUROCUPLE™ Group', 'Sham Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15146', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'contacts': [{'name': 'Jacques E. Chelly, MD, PhD, MBA', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UPMC East Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'contacts': [{'name': 'Amy Monroe, MPH, MBA', 'role': 'CONTACT', 'email': 'monroeal@upmc.edu', 'phone': '412-623-6382'}, {'name': 'Dayana Alsamsam, BSPS, MSc', 'role': 'CONTACT', 'email': 'alsamsamd@upmc.edu'}, {'name': 'Jacques E. Chelly, MD, PhD, MBA', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UPMC Shadyside Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '15237', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'contacts': [{'name': 'Jacques E. Chelly, MD, PhD, MBA', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UPMC Passavant Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'centralContacts': [{'name': 'Jacques E. Chelly, MD, PhD, MBA', 'role': 'CONTACT', 'email': 'ChelJE@anes.upmc.edu', 'phone': '(412)623-6904'}, {'name': 'Dayana Alsamsam, BSPS, MSc', 'role': 'CONTACT', 'email': 'alsamsamd@upmc.edu', 'phone': '412-123-4567'}], 'overallOfficials': [{'name': 'Jacques E. Chelly, MD, PhD, MBA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh / UPMC'}, {'name': 'Amy Monroe, MPH, MBA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Pittsburgh / UPMC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jacques E. Chelly', 'class': 'OTHER'}, 'collaborators': [{'name': 'nCap Medical', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor, Anesthesiology', 'investigatorFullName': 'Jacques E. Chelly', 'investigatorAffiliation': 'University of Pittsburgh'}}}}