A Nasal Applicator for the Treatment of Trigeminal Neuralgia
NCT ID: NCT01761604
Last Updated: 2017-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2011-12-31
2017-09-30
Brief Summary
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The 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.
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Detailed Description
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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.
The 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.
The 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.
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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Nasal ganglion block for TN
Sphenopalatine ganglion block using the Tx360™ device
Nasal ganglion block for TN
Interventions
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Nasal ganglion block for TN
Eligibility Criteria
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Inclusion Criteria
* Trigeminal Neuralgia
Exclusion Criteria
* Septal perforation
* Recent nasal/midface trauma (\< 3 months)
* Bleeding disorder such as Von Willebrand's disease or hemophilia
* Severe respiratory distress
* Neoplasm such as the following: Angiofibroma, sinus Tumors, Granuloma
* Congestion has been present more than 10 days, fever (define as temperature≥ 100.4 F)
* Current cocaine user
* Skin around and inside the nasal passage is dry, cracked, oozing, or bleeding
* Allergy to marcaine
* Pregnancy
18 Years
80 Years
ALL
No
Sponsors
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Chicago Anesthesia Pain Specialists
OTHER
Responsible Party
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Kenneth D Candido
Chairman of the Anesthesia Department at Advocate Illinois Masonic Medical Center
Principal Investigators
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Kenneth D Candido, M.D.
Role: PRINCIPAL_INVESTIGATOR
Chicago Anesthesia Pain Specialists
Locations
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Chicago Anesthesia Pain Specialists
Chicago, Illinois, United States
Countries
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Other Identifiers
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Advocate-IRB-5241
Identifier Type: -
Identifier Source: org_study_id
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