Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06272032
Status:
RECRUITING
Last Update Posted:
2024-02-22
First Post:
2024-01-27
Brief Title:
Prospective Multicenter Observational Study and Promotion of the Application of Focused Ultrasound in Allergic Rhinitis
Sponsor:
Chongqing Medical University
Organization:
Chongqing Medical University
Study Overview
Official Title:
Prospective Multicenter Observational Study and Promotion of the Application of Focused Ultrasound in Reduction of Hypertrophy and Desensitization for Allergic Rhinitis
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 hyperreactivityHigh-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 ARThrough 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
Detailed Description:
Ultrasound is a form of mechanical vibrational wave that can penetrate living tissues without causing harm to the tissue As a non-invasive physical modality ultrasound boasts advantages such as non-invasive safety excellent directional propagation strong penetration capability and optimal focusing effects Through actions such as cavitation mechanical force vibration and heat generation ultrasound can induce a series of structural and functional changes in tissue cells resulting in corresponding clinical effectsAs early as 2006 research reported that ultrasound when focused at specific depths beneath the nasal mucosa creates scattered punctate coagulation-type necrosis in the biological focus zone beneath the mucosa This process involves the dissolution and disappearance of nuclei in some vascular smooth muscle cells endothelial cell degeneration partial thrombosis formation vacuolar degeneration of neural cells and partial or complete necrosis of glandular cells The coagulation-type necrosis subsequently dissolves and is absorbed while the structure of nasal mucosa cup cells ciliated columnar epithelial cells and basal cells remains normal without damage to cilia and microvilliClinical studies indicate that focused ultrasound not only improves symptoms of allergic rhinitis AR but also holds certain advantages in preserving the structural and functional integrity of the nasal mucosa However challenges exist in the current application of focused ultrasound for AR including weak evidence from clinical studies insufficient long-term efficacy observations and limited understanding of treatment complications Moreover consensus is lacking on indications treatment intensity duration safety and complications avoidance demanding urgent resolutionIn light of these challenges and guided by the principle of minimizing harm to patients in treatment this study centered on the minimally invasive surgical treatment of reduction of hypertrophy and desensitization in AR aims to collaborate with six established tertiary hospitals in China proficient in ultrasound treatment for AR The study will conduct a prospective multicenter clinical research to observe the clinical efficacy and safety of ultrasound focus in AR explore its application value in AR and promote the safe and effective clinical use of focused ultrasound in AR The ultimate goal is to enhance the overall therapeutic effectiveness of AR benefiting a large population of AR patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None