Laser Posterior Nasal Nerve Neurolysis

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.

Conditions

• Rhinorrhea
• Sneezing
• Allergic Rhinitis
• Chronic Rhinitis
• Nasal Obstruction
• Nasal Congestion
• Nasal Allergies
• Nasal Stuffiness

Interventions

PROCEDURE

Laser posterior nasal nerve neurolysis

Posterior nasal nerve ablation using laser is performed through an angled nasal probe at 20 degrees and a 90-degree endoscope to deliver laser energy to the posterior nasal nerve area. The thermal energy is conducted to the middle meatus and the posterior superior part of the inferior turbinate, targeting the area supplied by the posterior nasal nerve. The ablation continues until there is widespread mucosal blanching and the formation of at least one continuous brown eschar

PROCEDURE

Sham surgery

The same laser surgical instrument is used to enter the nasal cavity for a sham procedure with minimal dosage. The energy setting uses the lowest limit of 0.5W with intermittent emission (0.01 second emission with 1 second rest), and the emission mode is Super Pulse to reduce heat dispersion. It is applied to the mucosal surface without blood supply at the lower edge of the middle turbinate for 2 minutes on each side, totaling only 1.2 seconds of cumulative laser emission. Compared to the experimental group using 2W energy with continuous irradiation for 2 minutes, the total energy release difference in the sham surgery group is only 1/400 of the experimental group (2W120sec/0.5W1.2sec). This is to produce the sound, light, and tactile effects of the laser, but without sufficient energy transfer to cause high-temperature mucosal changes and tissue alterations, serving as a high-quality sham surgery control group.

Sponsors & Collaborators

• Chiayi Christian Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-11-01

Primary Completion

2025-12-06

Completion

2026-12-31

Countries

• Taiwan

Study Locations