NCT05554731

Development and Application of a New Balloon Catheter for Intraairway Hemostasis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: First Affiliated Hospital of Wenzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	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.

Timeline

• Start date: 2022-10-01
• Primary completion: 2023-10-30
• Completion: 2023-10-30
• First posted: 2022-09-26
• Last updated: 2022-09-26

Locations

1 site across 1 country: China