A Nasal Applicator for the Treatment of Trigeminal Neuralgia
Completed · Not applicable
Conditions studied: Trigeminal Neuralgia
In brief
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. 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.
Key facts
- Study ID
- NCT01761604
- Run by
- Chicago Anesthesia Pain Specialists
- People needed
- 10
- Starts
- 2011-12-01
- Expected to finish
- 2017-09-01
- Last updated by the study team
- 2017-09-14
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 18- 80 years old
- Trigeminal Neuralgia
You may not qualify if…
- Nasal septal deformity such as: cleft lip and palate, choanal atresia
- 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
Where it is running
- Chicago Anesthesia Pain Specialists — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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