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.
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 device/procedure-related serious adverse
events, device/procedure 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.
Criteria and Procedures for Withdrawal/Termination of Trial Treatment
Subjects may prematurely terminate treatment or withdraw from the study due to any of the
following, but not limited to:
Medical or safety reasons deemed necessary by the investigator for the subject to
withdraw from the study;
Failure to meet inclusion criteria or meeting exclusion criteria after enrollment;
Subject's unwillingness to continue participating in the study for any reason;
Loss to follow-up (the investigator is unable to contact the subject to return to the
clinic for primary endpoint assessment and examination);
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 investigator's decision, or other reasons,
and the withdrawal reason should be recorded in the Case Report Form (CRF).
4．Expected Duration of Participation for Each Subject The expected duration of participation
for each subject is defined as the time from the subject's 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).
5．Monitoring 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).
6．Data 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 9.4 or higher software.
