Ignite Creation Date:
2025-12-26 @ 12:16 PM
Ignite Modification Date:
2025-12-29 @ 4:11 PM
Study NCT ID:
NCT06128200
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-25
First Post:
2023-11-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NEUROMARK Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'This is a single-blind study; participants will be blinded to the randomization assignment.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'A prospective, multicenter, randomized, sham-controlled, single-blinded, superiority trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-21', 'studyFirstSubmitDate': '2023-11-07', 'studyFirstSubmitQcDate': '2023-11-07', 'lastUpdatePostDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'rTNSS', 'timeFrame': '90-days post procedure follow-up', 'description': 'Comparison of the percentage of responders (participants with a 30% or greater reduction in rTNSS relative to baseline) between study arms at 90-days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Chronic Rhinitis']}, 'descriptionModule': {'briefSummary': 'The NEUROMARK RCT Study is a prospective, multicenter, randomized, sham-controlled, single-blinded, superiority trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nParticipant Must:\n\n1. Be ≥18 years of age.\n2. Have been experiencing rhinitis symptoms for a minimum of 6 months.\n3. Have moderate to severe symptoms of runny nose (individual rTNSS symptom rating of 2 or 3), mild to severe symptoms of nasal congestion (individual rTNSS symptom rating of 1,2, or 3), and a minimum total score of 5 (out of 12) at baseline.\n4. Be an appropriate candidate for bilateral NEUROMARK device treatment performed under local anesthesia.\n5. Be willing and able to comply with all study elements, as indicated by written informed consent.\n\nPrimary Exclusion Criteria:\n\nParticipant Must Not:\n\n1. Have clinically significant anatomic obstruction that in the investigator's opinion limit access to the posterior nose, including but not limited to severe septal deviation or perforation, nasal polyps, and/or sinonasal tumor.\n2. Have had previous sinus or nasal surgery within 6 months of study enrollment.\n3. Have previously undergone RF, cryotherapy, or other surgical interventions for rhinitis.\n4. Have rhinitis symptoms that are due to seasonal allergies only."}, 'identificationModule': {'nctId': 'NCT06128200', 'briefTitle': 'NEUROMARK Randomized Controlled Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Neurent Medical'}, 'officialTitle': 'Randomized Controlled Trial Comparing NEUROMARK System to Sham Control in Patients With Chronic Rhinitis', 'orgStudyIdInfo': {'id': 'CIP-0010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active', 'description': 'Subjects in this arm will undergo treatment with the NEUROMARK device.', 'interventionNames': ['Device: NEUROMARK System']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham', 'description': 'Subjects in this arm will undergo the procedure with a Sham device. Sham control participants will be offered the option to receive active treatment after the 90-day follow-up provided they still meet all eligibility criteria.', 'interventionNames': ['Device: Sham NEUROMARK System']}], 'interventions': [{'name': 'NEUROMARK System', 'type': 'DEVICE', 'description': 'The NEUROMARK System is indicated for use in otorhinolaryngology (ENT) surgery for creation of radiofrequency (RF) lesions to disrupt posterior nasal nerves in patients with chronic rhinitis.', 'armGroupLabels': ['Active']}, {'name': 'Sham NEUROMARK System', 'type': 'DEVICE', 'description': 'Sham ablation procedure using the NEUROMARK System', 'armGroupLabels': ['Sham']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35204', 'city': 'Homewood', 'state': 'Alabama', 'country': 'United States', 'facility': 'ExcelENT', 'geoPoint': {'lat': 33.47177, 'lon': -86.80082}}, {'zip': '36801', 'city': 'Opelika', 'state': 'Alabama', 'country': 'United States', 'facility': 'East Alabama ENT', 'geoPoint': {'lat': 32.64541, 'lon': -85.37828}}, {'zip': '90006', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Sensa Health', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95815', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Sacramento ENT', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '90503', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Breathe Clear Institute', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '33426', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'ENT & Allergy Associates of Florida', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '34952', 'city': 'Port Saint Lucie', 'state': 'Florida', 'country': 'United States', 'facility': 'ENT & Allergy Associates of Florida', 'geoPoint': {'lat': 27.29393, 'lon': -80.35033}}, {'zip': '46016', 'city': 'Anderson', 'state': 'Indiana', 'country': 'United States', 'facility': 'Ascension St. Vincent', 'geoPoint': {'lat': 40.10532, 'lon': -85.68025}}, {'zip': '40205', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Kentuckiana', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '40220', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Advanced ENT & Allergy', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '21204', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Centers for Advanced ENT Care', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '18017', 'city': 'Bethlehem', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Bethlehem ENT', 'geoPoint': {'lat': 40.62593, 'lon': -75.37046}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Methodist ENT Specialists', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '75708', 'city': 'McKinney', 'state': 'Texas', 'country': 'United States', 'facility': 'The ENT & Allergy Centers of Texas', 'geoPoint': {'lat': 33.19762, 'lon': -96.61527}}, {'zip': '23235', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Richmond ENT', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '98374-1145', 'city': 'Puyallup', 'state': 'Washington', 'country': 'United States', 'facility': 'ENT & Allergy Associates', 'geoPoint': {'lat': 47.18538, 'lon': -122.2929}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neurent Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}