Development and Application of a New Balloon Catheter for Intraairway Hemostasis
NCT ID: NCT05554731
Last Updated: 2022-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
200 participants
INTERVENTIONAL
2022-10-01
2023-10-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Safety of Balloon Guide Catheter in Mechanical Thrombectomy Patients
NCT03754738
Drug-coated Balloon Angioplasty for Patients With Symptomatic Vertebral Artery Stenosis
NCT03504657
Budd-Chiari Syndrome in China: Balloon Angioplasty Alone or Combined With Stent Placement?
NCT02201485
Atherectomy Followed With a Drug Coated Balloon in the Treatment of Long Femoropopliteal Lesions
NCT05868564
The Safety and Efficiency of Endovascular Treatment of Acute or Subacute Thromboembolic Occlusions of Lower Extremity.
NCT04861506
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
New balloon catheter for Endotracheal hemostasis + Traditional Therapy
1. Haemoptysis clinic for regular haemoptysis after treatment and life safety safeguard measures;
2. Balloon closure after informed consent (it can be blocked in emergency);
3. CTA (can be performed as an emergency prior to balloon blockage);
4. Artery interventional therapy (if necessary);
5. Surgery (if needed).
a New Balloon Catheter for Intraairway Hemostasis
In the treatment group, the new balloon catheter was inserted in three steps, that is, the tracheoscope was inserted into the airway to remove the blood in the airway and find the target bronchus.The new airway hemostatic balloon catheter was directly inserted through the tracheoscopy biopsy channel, and then directly inflated and fixed after positioning.Then exit the tracheoscope directly to complete.
Traditional Therapy
A six-step technique was adopted to place the traditional balloon catheter, that is, the tracheoscope was entered to find the target bronchus, the guide wire was inserted through the biopsy channel, the tracheoscope was exchanged to exit the tracheoscope, the catheter was entered through the guide wire exchange, the tracheoscope was re-entered, the catheter was positioned, inflated and fixed, and the tracheoscope was withdrawn.
Traditional Therapy
1. Haemoptysis clinic for regular haemoptysis after treatment and life safety safeguard measures;
2. CTA (can be performed as an emergency prior to balloon blockage);
3. Artery interventional therapy (if necessary);
4. Surgery (if needed).
a New Balloon Catheter for Intraairway Hemostasis
In the treatment group, the new balloon catheter was inserted in three steps, that is, the tracheoscope was inserted into the airway to remove the blood in the airway and find the target bronchus.The new airway hemostatic balloon catheter was directly inserted through the tracheoscopy biopsy channel, and then directly inflated and fixed after positioning.Then exit the tracheoscope directly to complete.
Traditional Therapy
A six-step technique was adopted to place the traditional balloon catheter, that is, the tracheoscope was entered to find the target bronchus, the guide wire was inserted through the biopsy channel, the tracheoscope was exchanged to exit the tracheoscope, the catheter was entered through the guide wire exchange, the tracheoscope was re-entered, the catheter was positioned, inflated and fixed, and the tracheoscope was withdrawn.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
a New Balloon Catheter for Intraairway Hemostasis
In the treatment group, the new balloon catheter was inserted in three steps, that is, the tracheoscope was inserted into the airway to remove the blood in the airway and find the target bronchus.The new airway hemostatic balloon catheter was directly inserted through the tracheoscopy biopsy channel, and then directly inflated and fixed after positioning.Then exit the tracheoscope directly to complete.
Traditional Therapy
A six-step technique was adopted to place the traditional balloon catheter, that is, the tracheoscope was entered to find the target bronchus, the guide wire was inserted through the biopsy channel, the tracheoscope was exchanged to exit the tracheoscope, the catheter was entered through the guide wire exchange, the tracheoscope was re-entered, the catheter was positioned, inflated and fixed, and the tracheoscope was withdrawn.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
First Affiliated Hospital of Wenzhou Medical University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The first affiliated hospital of wenzhou medical university
Wenzhou, Zhejiang, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
chengshui Chen
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2020C03067
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.