Prospective Multicenter Observational Study and Promotion of the Application of Focused Ultrasound in Reduction of Hypertrophy and Desensitization for Allergic Rhinitis

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

Allergic rhinitis (AR) is a common condition, with nearly 300 million affected individuals in China, significantly impacting the quality of life. Despite standardized drug treatments, approximately 20% of AR patients experience inadequate control and require surgical intervention. AR manifests as nasal itching, sneezing, clear nasal discharge, nasal congestion, primarily associated with inflammation-induced hypertrophy of nasal turbinates and a heightened neurogenic state of the nasal mucosa. Surgical treatment focuses on reducing hypertrophy of nasal turbinates and desensitizing neurogenic hyperreactivity.High-intensity focused ultrasound (HIFU), as a minimally invasive therapeutic modality in AR, is still in its early stages of application and requires further multicenter clinical studies and widespread adoption. This project collaborates with six established institutions proficient in ultrasound treatment for AR. It aims to conduct a prospective multicenter observational study and subsequent dissemination, emphasizing the application of reduction of hypertrophy and desensitization in AR.Through standardized case selection, subjective and objective measures such as subjective symptom scores, quality of life assessments, nasal reflex, and nasal resistance tests before and after treatment will be employed to evaluate the effectiveness and safety of HIFU in reducing hypertrophy and desensitizing aspects of AR. Simultaneously, building on our established Otolaryngology Head and Neck Surgery Alliance and Southwest Allergy Alliance, the research results will be promoted through lectures, hands-on guidance, training sessions, academic conferences, and other means to facilitate the application of HIFU in AR and benefit a larger population of AR patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Refractory AR.

• Patients exhibiting persistent mucosal hypersensitivity or high secretion state (rhinorrhea, sneezing, etc.).

Locations
Other Locations
China
Chongqing Medical University
RECRUITING
Chongqing
Contact Information
Primary
Shen Yang, Doctoral
sy_smile@sina.cn
15111953398
Time Frame
Start Date: 2023-08-01
Estimated Completion Date: 2025-07-31
Participants
Target number of participants: 240
Treatments
Active_comparator: High-intensity focused ultrasound (HIFU)
The High-Intensity Focused Ultrasound (HIFU) knife, also known as the High-Intensity Focused Ultrasound Tumor Treatment System or HIFU ablation therapy, abbreviated as the HIFU knife, is a non-invasive and non-intrusive tumor treatment method utilizing high-intensity focused ultrasound technology. This technology was successfully developed by the Ultrasound Medical Engineering Research Institute of Chongqing Medical University in 1997.
Placebo_comparator: Placebo
For patients in the Placebo treatment group, treatment is provided based on the severity of their symptoms, following the protocols outlined in the Allergic Rhinitis (AR) diagnosis and treatment guidelines. Patients are administered intranasal corticosteroids, oral antihistamines, oral leukotriene receptor antagonists, and intranasal antihistamines, as appropriate, in accordance with the severity of their symptoms.
Related Therapeutic Areas
Sponsors
Leads: Chongqing Medical University

This content was sourced from clinicaltrials.gov