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An exploratory single-center clinical study on the efficacy, safety and feasibility of incomplete interlobar fissure closure guided by bronchial navigation and positioning equipment

An exploratory single-center clinical study on the efficacy, safety and feasibility of incomplete interlobar fissure closure guided by bronchial navigation and positioning equipment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107559
Enrollment
Unknown
Registered
2025-08-14
Start date
2025-08-30
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory pneumothorax

Interventions

Experimental group:Bronchial blocking technique+Bronchial navigation equipment
Control group (self-control):Bronchial blocking technique

Sponsors

The Second Affiliated hospital of Fujian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Male or female, aged >=18 years old; 2. Patients with various types of pneumothorax with persistent air leakage after 7 days of continuous intercostal drainage; 3. The investigator evaluated that the subject is eligible for bronchial occlusion to treat refractory pneumothorax, and the responsible drainage bronchus can be identified via the blocking balloon; 4. Those whose chest CT shows incomplete interlobar fissures and whose drainage bronchi cannot be located by balloon exploration; 5.Voluntarily participate in the trial and sign the informed consent form;

Exclusion criteria

Exclusion criteria: 1. Contraindications for bronchoscopy: • Myocardial infarction within the past 1 month; • Active massive hemoptysis; Platelet count < 20×109/L; Female patients who are breastfeeding, pregnant or preparing for pregnancy; Malignant arrhythmia, unstable angina pectoris, severe cardiopulmonary insufficiency, hypertensive crisis, severe pulmonary hypertension, intracranial hypertension, acute cerebrovascular events, aortic dissection, aortic aneurysm, severe mental illness and extreme systemic failure, etc; 2.The presence of uncontrolled acute pulmonary infection or severe chronic infection at the target occlusion site; 3.Patients presenting with significant hemodynamic instability or uncontrolled respiratory failure; 4. Those who have undergone incomplete interlobar fissure closure but still have balloon occlusion and the responsible drainage bronchus cannot be determined; 5. Patients with electromagnetic active implant devices in their bodies; 6. Participants are allergic to anesthetics; Or have a history of multiple severe allergies or hereditary allergies; 7. Those who have participated in or are currently participating in drug clinical trials within 3 months prior to the screening, or have participated in other medical device clinical trials within 30 days; 8. The researchers believe that the patient has other circumstances that make them unsuitable for inclusion in this study.

Design outcomes

Primary

MeasureTime frame
The success rate of incomplete interlobular fissure closure;The cure rate of bronchial occlusion after interlobar fissure closure;

Secondary

MeasureTime frame
Thoracic drainage tube removal rate;

Countries

China

Contacts

Public ContactYiming Zeng

The Second Affiliated hospital of Fujian Medical University

zeng_yi_ming@126.com+86 595 22768177

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026