HemoptysisNCT05786781
An Exploratory Study on the Application of Transarterial CT Angiography in the Interventional Treatment of Massive Hemoptysis
A study testing Transarterial CT angiography in people with Hemoptysis, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
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 massive hemoptysis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemoptysis
- What is being tested?
- Transarterial CT angiography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 28 Mar 2023to 31 Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with massive hemoptysis（defined as more than 100mL per session or more than 300mL/day or with acute respiratory failure requiring mechanical ventilation or hemodynamic instability (systolic blood pressure < 90 mmHg), regardless of hemoptysis amount）
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei
About this study
This is a single-arm, exploratory study to evaluate the value of transarterial CT angiography applying Nexaris Angio-CT in the interventional treatment of massive hemoptysis
- Conditions
- Hemoptysis
- Being tested
- Transarterial CT angiography
- Medical subject headings
- Hemoptysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transarterial CT angiographyDevice
Transarterial catheter-directed CT angiography during interventional treatment of hemoptysis
| Study group | Role | What they receive |
|---|---|---|
| Transarterial CT angiography | Experimental | Transarterial catheter-directed CT angiography during interventional treatment of hemoptysis Receives: Device: Transarterial CT angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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, by calculating the matching rate between Angio-CT and selective angiography findings.
Measured: Intraoperative phase
In-hospital clinical success
either the complete cessation of hemoptysis or a clinically significant reduction in bleeding, defined as ≤ 5 mL/24 hours of blood-tinged sputum or fresh blood during the hospitalization period.
Measured: During the postoperative hospitalization period (i.e., the period after bronchial artery embolization until discharge)
Early hemoptysis recurrence rate
Recurrence rate of hemoptysis within 3 months after treatment
Measured: 3 months after treatment
Secondary outcomes (4)
Technical success rate
Technical success is defined as complete cessation of target blood flow confirmed by DSA
Measured: Intraoperative phase
Radiation exposure
Radiation exposure data were systematically collected from structured radiation dose reports. For Angio-CT scans, radiation exposure was quantified using the volume CT dose index (CTDIvol) and dose-length product (DLP). For digital subtraction angiography (DSA) and fluoroscopy, air kerma (AK) and dose-area product (DAP) were utilized as metrics.
Measured: Intraoperative phase
The amount of contrast agent consumed
The amount of contrast agent consumed during treatment
Measured: Intraoperative phase
Adverse events
AEs were monitored and classified according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. The CTCAE system grades AEs on a 5-point scale, with grade ≥ 3 denoting a serious AE.
Measured: Intraoperative phase and during 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start28 Mar 2023
- Primary completion30 Sep 2024
- Study completion31 Dec 2024
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 Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05786781
- Sponsor's protocol ID
- UHCT22759
- Status last verified
- Apr 2025
- First submitted
- 20 Feb 2023
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study on the Application of Transarterial CT Angiography in the Interventional Treatment of Massive Hemoptysis
- ClinicalTrials.gov ID
- NCT05786781
- Acronym / sponsor ID
- UHCT22759
- Conditions
- Hemoptysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 28 Mar 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 28 Mar 2023 (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.
This is a single-arm, exploratory study to evaluate the value of transarterial CT angiography applying Nexaris Angio-CT in the interventional treatment of massive hemoptysis
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transarterial CT angiography | Experimental | Device: Transarterial CT angiographyTransarterial catheter-directed CT angiography during interventional treatment of hemoptysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with massive hemoptysis（defined as more than 100mL per session or more than 300mL/day or with acute respiratory failure requiring mechanical ventilation or hemodynamic instability (systolic blood pressure < 90 mmHg), regardless of hemoptysis amount）
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Transarterial CT angiographyTransarterial catheter-directed CT angiography during interventional treatment of hemoptysis | Device | Transarterial CT angiography |
Primary outcome
The accuracy rate of transarterial CT angiography in the identification of culprit vessel
Time frame: Intraoperative phase
The accuracy rate of transarterial CT angiography in the identification of culprit vessel, by calculating the matching rate between Angio-CT and selective angiography findings.
In-hospital clinical success
Time frame: During the postoperative hospitalization period (i.e., the period after bronchial artery embolization until discharge)
either the complete cessation of hemoptysis or a clinically significant reduction in bleeding, defined as ≤ 5 mL/24 hours of blood-tinged sputum or fresh blood during the hospitalization period.
Early hemoptysis recurrence rate
Time frame: 3 months after treatment
Recurrence rate of hemoptysis within 3 months after treatment
4 secondary outcomes
Technical success rate
Time frame: Intraoperative phase
Radiation exposure
Time frame: Intraoperative phase
The amount of contrast agent consumed
Time frame: Intraoperative phase
Adverse events
Time frame: Intraoperative phase and during 3 months after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transarterial CT angiography in people with Hemoptysis, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 13 Apr 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The accuracy rate of transarterial CT angiography in the identification of culprit vessel (time frame: Intraoperative phase). 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 13 Apr 2025.