Single-center Clinical Study on the Safety and Effect of Bronchoscopic Cryotherapy in Patients With Chronic Cough

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

Chronic cough is one of the most common complaints in respiratory specialty clinics, imposing significant economic burden on patients and severely affecting their quality of life. Currently, the pathogenesis of chronic refractory cough remains incompletely understood, and treatment remains a major challenge in clinical practice. Cryotherapy treatment via bronchoscopy has shown efficacy in certain airway diseases, but there is currently no research reporting its effects on chronic refractory cough. The goal of this clinical trial is to learn if Cryotherapy treatment works to treat individuals with chronic cough. It will also learn about The safety and effectiveness of the cryotherapy treatment system produced by Ningbo SensCure Biotechnology Co., Ltd.. The main questions it aims to answer are: * Does cryotherapy treatment lower the frequency and severity of cough and enhance quality of life? * Will there be safety or operational performance issues when using this cryotherapy treatment system? Researchers will compare cryotherapy treatment with no treatment to determine if cryotherapy treatment is effective for treating chronic cough. Participants will: * Take routine bronchoscopy examination, lavage, and mucosal biopsy ,with/without cryotherapy treatment locally (around the left and right main bronchi, upper trachea, and carina) * undergo a screening period of approximately 28 days. Follow-up visits and necessary examinations will be scheduled for the 3rd day after treatment initiation and at weeks 1, 2, 4, 8, and 12 thereafter. * Monitor vital signs and clinical manifestations.

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

• Age between 18 and 65 years, regardless of gender;

• Patients with cough of unknown etiology or cause, lasting for more than 8 weeks;

• Cough Visual Analogue Scale (VAS) score ≥ 50;

• Willingness to provide voluntary informed consent and agree to follow-up;

• The investigator believes that the overall status of the subjects does not affect the evaluation and completion of the trial.

Locations
Other Locations
China
The First Affiliated Hospital of Guangzhou Medical University
RECRUITING
Guangzhou
Contact Information
Primary
Shiyue Li
lishiyue@gird.cn
+86 13902233925
Time Frame
Start Date: 2024-04
Estimated Completion Date: 2024-09
Participants
Target number of participants: 20
Treatments
Experimental: Cryotherapy Treatment
The plan is to enroll 20 patients, who will be randomly assigned in a 1:1 ratio to the experimental group and the control group according to the protocol criteria. The experimental group will undergo routine bronchoscopy examination, lavage, and mucosal biopsy, followed by cryotherapy treatment locally (around the left and right main bronchi, upper trachea, and carina).
Sham_comparator: Not receiving cryotherapy treatment
The plan is to enroll 20 patients, who will be randomly assigned in a 1:1 ratio to the experimental group and the control group according to the protocol criteria. The control group will undergo routine bronchoscopy examination, lavage, and mucosal biopsy.
Related Therapeutic Areas
Sponsors
Leads: Guangzhou Medical University
Collaborators: Ningbo SensCure Biotechnology Co., Ltd.

This content was sourced from clinicaltrials.gov