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NCT05786781 Clinical Trial

An Exploratory Study on the Application of Transarterial CT Angiography in the Interventional Treatment of Hemoptysis

Hemoptysis Clinical Trial

Official title:
An Exploratory Study on the Application of Transarterial CT Angiography in the Interventional Treatment of Hemoptysis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05786781
Other study ID # UHCT22759
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 2, 2023
Est. completion date March 1, 2024

Study information
Verified date February 2023
Source Wuhan Union Hospital, China
Contact Bin Liang
Phone +8618086006235
Email 553954881@qq.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a single-arm, exploratory study to evaluate the value of transarterial CT angiography applying Nexaris Angio-CT in the interventional treatment of hemoptysis

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date March 1, 2024
Est. primary completion date March 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with massive hemoptysis(defined as more than 100mL per session or more than 300mL/day)or patients with recurrent mild to moderate hemoptysis and failed conservative treatment history Exclusion Criteria: - Pregnancy - Patients with a previous history of bronchial artery embolization - Uncorrectable severe infection, coagulation dysfunction, organ failure or cachexia, severe contrast agent allergy, and other interventional treatment contraindications

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Transarterial CT angiography
Transarterial catheter-directed CT angiography during interventional treatment of hemoptysis

Locations
Country Name City State
China Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology Wuhan Hubei

Sponsors (1)
Lead Sponsor Collaborator
Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary The accuracy rate of transarterial CT angiography in the identification of culprit vessel The accuracy rate of transarterial CT angiography in the identification of culprit vessel Intraoperative phase
Primary Total effective dose The total effective dose is the sum of the effective dose delivered by CT, fluoroscopy and DSA. The effective dose delivered by CT was determined using the dose length product (expressed as mGy*cm) and subsequently converted to the ED using a suitable conversion factor (0.014 mSv mGy-1 cm-1). The effective dose delivered by fluoroscopy and DSA was determined using the dose area product (expressed as mGy*cm2) and subsequently converted to the ED using a suitable conversion factor (0.12 mSv Gy-1cm-2). The dose length product and the dose area product were acquired on radiation dose structured reports. Intraoperative phase
Primary Early hemoptysis recurrence rate Recurrence rate of hemoptysis within 3 months after treatment 3 months after treatment
Secondary Technical success rate Technical success is defined as complete cessation of target blood flow confirmed by DSA Intraoperative phase
Secondary Immediate hemostasis success rate Hemostasis rate within 24 hours after treatment 24 hours after treatment
Secondary The amount of contrast agent consumed The amount of contrast agent consumed during treatment Intraoperative phase
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