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A prospective, single-blind, single-center, two-arm study to evaluate the feasibility and safety of cryoablation of the posterior nasal nerve and anterior ethmoidal nerve in the treatment of moderate to severe persistent allergic rhinitis

Safety and efficacy of cryoablation of the posterior nasal nerve and anterior ethmoidal nerve in the treatment of allergic rhinitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300067308
Enrollment
Unknown
Registered
2023-01-04
Start date
2023-03-01
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic rhinitis

Interventions

group 1:cryoablation of the posterior nasal nerve
group 2:cryoablation of the posterior nasal nerve and anterior ethmoidal nerve

Sponsors

Shanghai East Hospital, School of Medicine, Tongji University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
21 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age 21-65 years old, gender is not limited; 2. For patients with clearly diagnosed AR, the diagnostic criteria refer to the Guidelines for the Diagnosis and Treatment of Allergic Rhinitis in China (2022): (1) Symptoms: 2 or more symptoms such as paroxysmal sneezing, clear watery nasal discharge, nasal itching, and nasal congestion, which last or accumulate for more than 1 hour every day, and may be accompanied by eye symptoms such as tearing, itchy eyes, and red eyes; (2) Signs: Pale nasal mucosa, edema, and watery nasal discharge are common; (3) Allergen detection: at least one allergen SPT and/or serum-specific IgE positive, or nasal challenge test positive; (results within one year are all valid); 3. Symptom onset >= 4 days/week, and >= 4 consecutive weeks; 4. Moderate-severe AR, that is, the symptoms are severe or severe, and have a significant impact on the quality of life (including sleep, daily life, work and study); 5. rTNSS >= 8 points within 12 hours, of which the nasal congestion score >= 2 points; 6. Patients and guardians are informed and agree to participate in the research.

Exclusion criteria

Exclusion criteria: 1. Those who have taken steroids in the past 2 weeks and antihistamines or external steroids in 1 week; 2. Nasal space-occupying lesions and structural abnormalities, including but not limited to: nasal polyps, nasal masses, meninges-encephalocele, congenital nostril atresia, congenital pyriform stenosis, maxillary frontal process thickening and inward shifting, deviated nasal septum, perforated nasal septum, pneumatization of nasal middle nail, etc.; 3. Combining with asthma attacks; 4. Patients with serious primary diseases such as cardiovascular, cerebrovascular, liver, kidney, hematopoietic system; 5. Those who had nasal sinus surgery in the past, resulting in obvious changes in the anatomical structure of the back of the nose; 6. Those who have received head and neck radiation therapy in the past; 7. Those with active or chronic sinus infection; 8. Those who have active coagulation disorder or are receiving anticoagulant therapy and cannot safely stop the drug for 2 weeks; 9. People with dry eye syndrome in the past; 10. Pregnant, lactating or pregnant women; 11. Active smokers, or continuous smokers in the past 6 months; 12. Any physical condition that the researcher believes may seriously affect the research results or increase the risk.

Design outcomes

Primary

MeasureTime frame
reflective Total Nasal Symptom Score 3 months after surgery;

Secondary

MeasureTime frame
rTNSS at 7 days, 1 month, 6 months, and 12 months after surgery;Rhinoconjunctivitis Quality of Life Questionnaire;

Countries

China

Contacts

Public ContactZhaoxin Ma

Shanghai East Hospital, School of Medicine, Tongji University

mzhx114@163.com+86 13310110889

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026