UnknownNot Applicable

Development and Application of a New Balloon Catheter for Intraairway Hemostasis

China200 participantsStarted 2022-10-01

Plain-language summary

Massive hemoptysis is a serious disease of respiratory system, which seriously endangers the life of patients. There are obvious difficulties in the treatment of hemoptysis. In the traditional treatment, patients still have the risk of massive hemoptysis and suffocation, and the risk control in the treatment process cannot be ensured. Intra - airway interventional therapy, especially the hemostatic technique of intra - airway balloon catheter, is an important means to control the risk of hemoptysis. However, the current intraairway balloon catheter therapy technology is immature, complicated and difficult to operate, and the cost is high. There is a lack of special balloon for hemostasis, and the balloon borrowed for other purposes cannot meet the needs of hemoptysis treatment. Therefore, it is urgent to develop a new balloon catheter for airway hemostasis, which has simple technical operation, easy to master and popularize, efficient and safe function and structure. According to this requirement, this project designed and developed hemostatic balloon catheter with multiple functions such as self-guiding, anti-displacement, anti-leakage and detachable rear end, so as to make the treatment of massive hemoptysis more safe and effective, simpler and faster, so as to be widely applied in clinical practice.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * The patients were 18-75 years, male or non-pregnant female; * Meet the clinical definition of massive hemoptysis (blood loss ≥100ml each time or ≥500ml 24h); * The patient/legal authorized representative understood the purpose and procedure of the test and voluntarily signed the informed consent. Exclusion Criteria: * Patients and their family members have no subjective treatment intention;Patients fail to cooperate or sign preoperative informed consent; * The obvious effect of balloon catheter therapy is not ideal; * Severe arrhythmia, acute myocardial ischemia; * blood pressure is not effectively controlled (diastolic blood pressure ≥95mmHg or systolic blood pressure ≥150mmHg); * Severe coagulopathy; * Severe organ insufficiency (except respiratory insufficiency); * Allergic to narcotic drugs; * Pregnant women, those who are breast-feeding or trying to conceive; * Patients who do not wish to sign informed consent; * Patients who failed to follow up; * Other patients deemed unsuitable for the study by the investigator.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Immediate intraoperative success rate

Timeframe: Immediately after surgery

Success rate of hemostasis 1 day after operation

Timeframe: 1 day after operation

Intraoperative complication

Timeframe: During surgery

Trial details

NCT IDNCT05554731

SponsorFirst Affiliated Hospital of Wenzhou Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-30

Contact for this trial

Chen ChengShui, doctor

86-13806889081 wzchencs@163.com

View on ClinicalTrials.gov More Hemoptysis trials