HemoptysisNCT05554731
Development and Application of a New Balloon Catheter for Intraairway Hemostasis
A study testing a New Balloon Catheter for Intraairway Hemostasis and Traditional Therapy in people with Hemoptysis, run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hemoptysis
- What is being tested?
- a New Balloon Catheter for Intraairway Hemostasis and Traditional Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 30 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The first affiliated hospital of wenzhou medical university
Wenzhou, Zhejiang, 325000
chengshui Chen
About this study
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.
Read more
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.
Read the detailed description
This study are aimed to investigate the safety and effectiveness of the new intraairway hemostatic balloon catheter in the treatment of massive hemoptysis, as well as the superior efficacy compared with the traditional treatment strategy of massive hemoptysis.
- Conditions
- Hemoptysis
- Being tested
- a New Balloon Catheter for Intraairway Hemostasis, Traditional Therapy
- Medical subject headings
- Hemoptysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a New Balloon Catheter for Intraairway HemostasisDevice
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 TherapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| New balloon catheter for Endotracheal hemostasis + Traditional Therapy | Experimental | 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). Receives: Device: a New Balloon Catheter for Intraairway Hemostasis; Device: Traditional Therapy |
| Traditional Therapy | Active comparator | 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). Receives: Device: a New Balloon Catheter for Intraairway Hemostasis; Device: Traditional Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate intraoperative success rate
Immediate intraoperative success rate
Measured: Immediately after surgery
Success rate of hemostasis 1 day after operation
Success rate of hemostasis 1 day after operation
Measured: 1 day after operation
Intraoperative complication
Significant increase in hemoptysis requiring other emergency management or suspension of operations, asphyxia, death, new arrhythmias, persistent worsening hypoxemia.
Measured: During surgery
Secondary outcomes (15)
Success rate of hemostasis 3 days and 1 and 2 weeks after operation
Success rate of hemostasis 3 days and 1 and 2 weeks after operation
Measured: 3 days and 1 and 2 weeks after operation
The bleeding time
The bleeding time
Measured: From date of randomization until the date of second operation , assessed up to 13 months
The operation rate of balloon occlusion again
The operation rate of balloon occlusion again
Measured: From date of randomization until the date of second operation , assessed up to 13 months
Measurement indexes of follow-up treatment measures
Including CTA and its preparation time, rate of arterial embolization surgery and proportion of emergency surgery.
Measured: From date of randomization until the date of second operation , assessed up to 13 months
Anesthesia complications
Complications after anesthesia including hypotension and shock, postoperative new tracheal intubation, coma and cerebrovascular accident.
Measured: During surgery
hyoxemia
For more than 2 hours, oxygen saturation drops below 90%.
Measured: From date of randomization until the date of second operation , assessed up to 13 months
Other complications
venous thrombosis of lower limbs
Measured: From date of randomization until the date of second operation , assessed up to 13 months
Balloon closure operation time
Compared with the traditional dilated balloon group, the operation time of balloon closure was calculated
Measured: up to 13 months
success rate of placement
success rate of placement
Measured: From date of randomization until death , assessed up to 13 months
time and incidence of balloon leakage
time and incidence of balloon leakage (under the premise of two inflations per day)
Measured: From date of randomization until the date of second operation , assessed up to 13 months
incidence of balloon displacement
incidence of balloon displacement (including the discount and distortion in the airway)
Measured: From date of randomization until the date of second operation , assessed up to 13 months
Nasal and bronchial mucosa injury
Compared with the traditional dilated balloon group, the damage of nasal and bronchial mucosa after balloon closure was observed
Measured: up to 13 months
Rate of hemoptysis after balloon occlusion
compared with traditional balloon dilation group
Measured: up to 13 months
Rate of re-balloon closure
compared with traditional balloon dilation group
Measured: up to 13 months
Incomplete completion rate of balloon closure operation
compared with traditional balloon dilation group
Measured: up to 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start1 Oct 2022 (estimated)
- Primary completion30 Oct 2023 (estimated)
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemoptysisStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05554731
- Sponsor's protocol ID
- 2020C03067
- Status last verified
- Sep 2022
- First submitted
- 19 Dec 2021
- Last updated
- 26 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Application of a New Balloon Catheter for Intraairway Hemostasis
- ClinicalTrials.gov ID
- NCT05554731
- Acronym / sponsor ID
- 2020C03067
- Conditions
- Hemoptysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 26 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study are aimed to investigate the safety and effectiveness of the new intraairway hemostatic balloon catheter in the treatment of massive hemoptysis, as well as the superior efficacy compared with the traditional treatment strategy of massive hemoptysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New balloon catheter for Endotracheal hemostasis + Traditional Therapy | Experimental | Device: a New Balloon Catheter for Intraairway Hemostasis, Device: Traditional Therapy1. 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). |
| Traditional Therapy | Active comparator | Device: a New Balloon Catheter for Intraairway Hemostasis, Device: Traditional Therapy1. 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). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| a New Balloon Catheter for Intraairway HemostasisIn 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. | Device | New balloon catheter for Endotracheal hemostasis + Traditional Therapy, Traditional Therapy |
| Traditional TherapyA 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. | Device | New balloon catheter for Endotracheal hemostasis + Traditional Therapy, Traditional Therapy |
Primary outcome
Immediate intraoperative success rate
Time frame: Immediately after surgery
Immediate intraoperative success rate
Success rate of hemostasis 1 day after operation
Time frame: 1 day after operation
Success rate of hemostasis 1 day after operation
Intraoperative complication
Time frame: During surgery
Significant increase in hemoptysis requiring other emergency management or suspension of operations, asphyxia, death, new arrhythmias, persistent worsening hypoxemia.
15 secondary outcomes
Success rate of hemostasis 3 days and 1 and 2 weeks after operation
Time frame: 3 days and 1 and 2 weeks after operation
The bleeding time
Time frame: From date of randomization until the date of second operation , assessed up to 13 months
The operation rate of balloon occlusion again
Time frame: From date of randomization until the date of second operation , assessed up to 13 months
Measurement indexes of follow-up treatment measures
Time frame: From date of randomization until the date of second operation , assessed up to 13 months
Anesthesia complications
Time frame: During surgery
hyoxemia
Time frame: From date of randomization until the date of second operation , assessed up to 13 months
Other complications
Time frame: From date of randomization until the date of second operation , assessed up to 13 months
Balloon closure operation time
Time frame: up to 13 months
success rate of placement
Time frame: From date of randomization until death , assessed up to 13 months
time and incidence of balloon leakage
Time frame: From date of randomization until the date of second operation , assessed up to 13 months
incidence of balloon displacement
Time frame: From date of randomization until the date of second operation , assessed up to 13 months
Nasal and bronchial mucosa injury
Time frame: up to 13 months
Rate of hemoptysis after balloon occlusion
Time frame: up to 13 months
Rate of re-balloon closure
Time frame: up to 13 months
Incomplete completion rate of balloon closure operation
Time frame: up to 13 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a New Balloon Catheter for Intraairway Hemostasis and Traditional Therapy in people with Hemoptysis, run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chen ChengShui, doctor (86-13806889081 ext. 8613806889081, wzchencs@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immediate intraoperative success rate (time frame: Immediately after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2022.