Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2026-01-22 @ 4:03 PM
Study NCT ID:
NCT01761604
Status:
COMPLETED
Last Update Posted:
2017-09-14
First Post:
2013-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Nasal Applicator for the Treatment of Trigeminal Neuralgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014277', 'term': 'Trigeminal Neuralgia'}], 'ancestors': [{'id': 'D020433', 'term': 'Trigeminal Nerve Diseases'}, {'id': 'D005156', 'term': 'Facial Neuralgia'}, {'id': 'D005155', 'term': 'Facial Nerve Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-13', 'studyFirstSubmitDate': '2013-01-02', 'studyFirstSubmitQcDate': '2013-01-03', 'lastUpdatePostDateStruct': {'date': '2017-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Modified Brief Pain inventory (short form)', 'timeFrame': 'Before procedure and after procedure', 'description': 'Before procedure, baseline. And after procedure day 1, 7, 14, 21, and 28.'}], 'primaryOutcomes': [{'measure': 'Pain intensity numeric rating scale', 'timeFrame': 'Before procedure and after procedure', 'description': 'Change in pain intensity before procedure, baseline. And after procedure 15 minutes, 30 minutes, day 1, 7, 14, 21, and 28.'}], 'secondaryOutcomes': [{'measure': "Patient's global impression of change", 'timeFrame': 'After procedure', 'description': 'Before procedure, baseline. And after procedure 30 minutes, day 1, 7, 14, 21, and 28.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Trigeminal Neuralgia']}, 'descriptionModule': {'briefSummary': 'The pain from Trigeminal Neuralgia (TN) imposes a substantial burden on patients in daily function and reduces quality of life. The sphenopalatine ganglion, located in the posterior part of the middle nasal turbinate, is involved in the pain associated to TN, by blocking the sphenopalatine ganglion relieves patients from the symptoms. However, methods currently in use to accomplish this are either cumbersome for the patient or invasive regarding the puncture of structures.\n\nThe purpose of this study is to evaluate the efficacy of Tx360™, a new nasal applicator device, in the treatment of TN. A local anesthetic will be delivered on the ganglion area. We are expecting that this new device will provide at least the same pain relief as the previously described approaches. However, this nasal applicator is intended to be an easy and non invasive method for office use.', 'detailedDescription': 'The pain from Trigeminal Neuralgia (TN) imposes a substantial burden on patients in daily function and reduces quality of life. Pain severity correlates with reduced measures of daily functioning, and overall health status.\n\nThe sphenopalatine ganglion, located in the posterior part of the middle nasal turbinate, is involved in the pain associated to TN, by blocking the sphenopalatine ganglion relieves patients from the symptoms. However, methods currently in use to accomplish this are either cumbersome for the patient or invasive regarding the puncture of structures.\n\nThe purpose of this study is to evaluate the efficacy of Tx360™, a new nasal applicator device, in the treatment of TN. The Tx360™ is a single use nasal applicator that can reach the sphenopalatine ganglion area. It is designed to dispense medications through a flexible canula.\n\nThe patients with TN will receive a 0.5 mL spray of local anesthetic on the ganglion area, and measure the change in pain intensity and quality of life.\n\nWe are expecting that this new device will provide at least the same pain relief as the previously described approaches. However, this nasal applicator is intended to be an easy and non invasive method for office use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18- 80 years old\n* Trigeminal Neuralgia\n\nExclusion Criteria:\n\n* Nasal septal deformity such as: cleft lip and palate, choanal atresia\n* Septal perforation\n* Recent nasal/midface trauma (\\< 3 months)\n* Bleeding disorder such as Von Willebrand's disease or hemophilia\n* Severe respiratory distress\n* Neoplasm such as the following: Angiofibroma, sinus Tumors, Granuloma\n* Congestion has been present more than 10 days, fever (define as temperature≥ 100.4 F)\n* Current cocaine user\n* Skin around and inside the nasal passage is dry, cracked, oozing, or bleeding\n* Allergy to marcaine\n* Pregnancy"}, 'identificationModule': {'nctId': 'NCT01761604', 'briefTitle': 'A Nasal Applicator for the Treatment of Trigeminal Neuralgia', 'organization': {'class': 'OTHER', 'fullName': 'Chicago Anesthesia Pain Specialists'}, 'officialTitle': 'The Use of Tx360™ Nasal Applicator for Sphenopalatine Ganglion Block in the Treatment of Trigeminal Neuralgia', 'orgStudyIdInfo': {'id': 'Advocate-IRB-5241'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Nasal ganglion block for TN', 'description': 'Sphenopalatine ganglion block using the Tx360™ device', 'interventionNames': ['Device: Nasal ganglion block for TN']}], 'interventions': [{'name': 'Nasal ganglion block for TN', 'type': 'DEVICE', 'armGroupLabels': ['Nasal ganglion block for TN']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60657', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Chicago Anesthesia Pain Specialists', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Kenneth D Candido, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chicago Anesthesia Pain Specialists'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chicago Anesthesia Pain Specialists', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chairman of the Anesthesia Department at Advocate Illinois Masonic Medical Center', 'investigatorFullName': 'Kenneth D Candido', 'investigatorAffiliation': 'Chicago Anesthesia Pain Specialists'}}}}