Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06378671
Status:
RECRUITING
Last Update Posted:
2024-04-25
First Post:
2024-04-07
Brief Title:
Single-center Clinical Study on the Safety and Effect of Bronchoscopic Cryotherapy in Patients With Chronic Cough
Sponsor:
Guangzhou Medical University
Organization:
Guangzhou Medical University
Study Overview
Official Title:
Single-center Clinical Study on the Safety and Effect of Bronchoscopic Cryotherapy in Patients With Chronic Cough
Status:
RECRUITING
Status Verified Date:
2024-04
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:
ColdCough
Brief 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 withwithout 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
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 withwithout 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
Detailed Description:
1 Objective The objective is to treat patients with chronic cough using the cryotherapy treatment system including cryotherapy ablation equipment and associated cryotherapy ablation catheters to improve cough symptoms and enhance patient quality of life Additionally to evaluate the safety and effectiveness of the cryotherapy treatment system produced by Ningbo SensCure Biotechnology Co Ltd and to provide scientifically reliable data for further formal clinical trials
2 content This is a prospective randomized controlled small-sample clinical trial with plans to enroll 20 participants The experimental device is the cryotherapy treatment system developed and manufactured by Ningbo SensCure Biotechnology Co Ltd including cryotherapy ablation equipment and associated cryotherapy ablation catheters Safety evaluation criteria including the incidence of deviceprocedure-related serious adverse events deviceprocedure adverse event rate incidence of serious adverse events and device defect rate and effectiveness evaluation criteria including cough visual analog scale score number of coughs within 2 hours modified cough score scale Leicester Cough Questionnaire and cough sensitivity testing will be used to assess the safety and effectiveness of the cryotherapy treatment system for treating patients with chronic cough
3 Criteria and Procedures for WithdrawalTermination of Trial Treatment
Subjects may prematurely terminate treatment or withdraw from the study due to any of the following but not limited to
1 Medical or safety reasons deemed necessary by the investigator for the subject to withdraw from the study
2 Failure to meet inclusion criteria or meeting exclusion criteria after enrollment
3 Subjects unwillingness to continue participating in the study for any reason
4 Loss to follow-up the investigator is unable to contact the subject to return to the clinic for primary endpoint assessment and examination
5 Termination of the study requested by the investigator or the company for any reason
For all subjects who prematurely terminate the study the investigator should obtain the reason for withdrawal as much as possible such as adverse events correction of ineffective treatment withdrawal from the trial based on the investigators decision or other reasons and the withdrawal reason should be recorded in the Case Report Form CRF
4Expected Duration of Participation for Each Subject The expected duration of participation for each subject is defined as the time from the subjects signing of the informed consent form to the end of the final follow-up visit According to the trial design the visit schedule for each subject is as follows Visit 1 screening period pre-operative -28 days to treatment period Visit 2 treatment period Day 0 Visit 3 Day 3 1 day Visit 4 Week 1 1 day Visit 5 Week 2 3 days Visit 6 Week 4 3 days Visit 7 Week 8 7 days and Visit 8 Week 12 7 days
5Monitoring Plan Executor Monitor Monitoring Content Whether the trial protocol is followed whether all Case Report Form CRF entries are correct complete and consistent with the original documents such as medical records and physical examination reports and whether there are any errors or omissions in the data Since most of the data in the CRF are transcribed from original sources such as medical records and physical examination reports much of the content is secondary data Therefore during monitoring the content of the CRF needs to be meticulously cross-checked with the original documents to ensure that the data in the CRF are completely consistent with the original data This process is also known as Source Data Verification SDV
6Data Management and Statistical Analysis Methods A separate data folder will be established for each participant and dedicated personnel will be responsible for data collection and entry Adhering to Good Clinical Practice GCP principles it is essential to ensure the authenticity and traceability of the data retaining all raw data for verification purposes Statistical analysis of the data will be conducted using SAS 94 or higher software
2 content This is a prospective randomized controlled small-sample clinical trial with plans to enroll 20 participants The experimental device is the cryotherapy treatment system developed and manufactured by Ningbo SensCure Biotechnology Co Ltd including cryotherapy ablation equipment and associated cryotherapy ablation catheters Safety evaluation criteria including the incidence of deviceprocedure-related serious adverse events deviceprocedure adverse event rate incidence of serious adverse events and device defect rate and effectiveness evaluation criteria including cough visual analog scale score number of coughs within 2 hours modified cough score scale Leicester Cough Questionnaire and cough sensitivity testing will be used to assess the safety and effectiveness of the cryotherapy treatment system for treating patients with chronic cough
3 Criteria and Procedures for WithdrawalTermination of Trial Treatment
Subjects may prematurely terminate treatment or withdraw from the study due to any of the following but not limited to
1 Medical or safety reasons deemed necessary by the investigator for the subject to withdraw from the study
2 Failure to meet inclusion criteria or meeting exclusion criteria after enrollment
3 Subjects unwillingness to continue participating in the study for any reason
4 Loss to follow-up the investigator is unable to contact the subject to return to the clinic for primary endpoint assessment and examination
5 Termination of the study requested by the investigator or the company for any reason
For all subjects who prematurely terminate the study the investigator should obtain the reason for withdrawal as much as possible such as adverse events correction of ineffective treatment withdrawal from the trial based on the investigators decision or other reasons and the withdrawal reason should be recorded in the Case Report Form CRF
4Expected Duration of Participation for Each Subject The expected duration of participation for each subject is defined as the time from the subjects signing of the informed consent form to the end of the final follow-up visit According to the trial design the visit schedule for each subject is as follows Visit 1 screening period pre-operative -28 days to treatment period Visit 2 treatment period Day 0 Visit 3 Day 3 1 day Visit 4 Week 1 1 day Visit 5 Week 2 3 days Visit 6 Week 4 3 days Visit 7 Week 8 7 days and Visit 8 Week 12 7 days
5Monitoring Plan Executor Monitor Monitoring Content Whether the trial protocol is followed whether all Case Report Form CRF entries are correct complete and consistent with the original documents such as medical records and physical examination reports and whether there are any errors or omissions in the data Since most of the data in the CRF are transcribed from original sources such as medical records and physical examination reports much of the content is secondary data Therefore during monitoring the content of the CRF needs to be meticulously cross-checked with the original documents to ensure that the data in the CRF are completely consistent with the original data This process is also known as Source Data Verification SDV
6Data Management and Statistical Analysis Methods A separate data folder will be established for each participant and dedicated personnel will be responsible for data collection and entry Adhering to Good Clinical Practice GCP principles it is essential to ensure the authenticity and traceability of the data retaining all raw data for verification purposes Statistical analysis of the data will be conducted using SAS 94 or higher software
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