Laser Posterior Nasal Nerve Neurolysis: a Randonmized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This clinical trial aims to learn if laser posterior nasal nerve neurolysis can treat chronic rhinitis in adults. It will also learn about the safety of laser posterior nasal nerve neurolysis. The main questions it aims to answer are: 1. Does laser posterior nasal nerve neurolysis improve chronic rhinitis symptoms? 2. What side-effects or complications do participants have after laser posterior nasal nerve neurolysis? Researchers will compare laser posterior nasal nerve neurolysis to a placebo(a sham surgery with the same device and sound to see if laser posterior nasal nerve neurolysis works to treat chronic rhinitis. Participants will 1. Receive laser posterior nasal nerve neurolysis in the office as local anesthesia surgery. 2. Visit the clinic in the first week, first month, and 3rd months after the surgery. 3. Record their symptom scores before the surgery and during each follow-up visit.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Age between 18 and 65 years old

• Chronic rhinitis symptoms for at least 6 months that have not responded effectively to medication (should include at least Intranasal corticosteroid (ICS) combined with intermittent use of oral antihistamine and, as needed, combination nasal spray) or where medication has not provided sustained improvement

• Total rTNSS ≥ 5 with Moderate to severe rhinorrhea symptoms (24-hour reflective Total Nasal Symptom Score \[rTNSS\] rhinorrhea score of 2-3) and mild to severe nasal congestion symptoms (rTNSS nasal congestion score of 1-3)

• All enrolled patients routinely undergo endonasal endoscopic examination, or have had a sinus CT within the past month confirming no significant rhinosinusitis.

Locations
Other Locations
Taiwan
Ditmanson Medical Foundation Chia-Yi Christian Hospital
RECRUITING
Chiayi City
Contact Information
Primary
Chien Yu Huang, MD
skyf16@gmail.com
+886-5-2765041
Time Frame
Start Date: 2024-11-01
Estimated Completion Date: 2026-12
Participants
Target number of participants: 120
Treatments
Active_comparator: Laser surgery
Posterior nasal nerve ablation using laser to deliver laser energy to the posterior nasal nerve area.
Sham_comparator: Sham surgery
Sham surgery is performed with the same laser surgical instrument used to enter the nasal cavity for a sham procedure with minimal dosage.
Related Therapeutic Areas
Sponsors
Leads: Chiayi Christian Hospital

This content was sourced from clinicaltrials.gov