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A clinical study on the diagnostic value and safety of ultrasound-guided transbronchial ultrathine cryoprobe for peripheral pulmonary lesions

A clinical study on the diagnostic value and safety of ultrasound-guided transbronchial ultrathine cryoprobe for peripheral pulmonary lesions

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084186
Enrollment
Unknown
Registered
2024-05-11
Start date
2023-11-01
Completion date
Unknown
Last updated
2024-05-13

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

Conditions

peripheral pulmonary lesions

Interventions

Group A:Fine Bronchoscope and 1.1mm Cryoprobe
Group B:Ultrafine Bronchoscope and 1.1mm Cryoprobe
Group C:Fine bronchoscope combined with ultrafine bronchoscope - 1.1mm cryoprobe

Sponsors

Department of Respiratory and Critical Care Medicine, Key Laboratory of Respiratory Disease of Ningbo, The First Affiliated Hospital of Ningbo University, Ningbo, China.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1.Aged >= 16 years; 2. Chest imaging examination indicates the presence of peripheral pulmonary lesions in at least one site ( max diameter from 8mm to 50mm); 3. Patients whose diagnosis cannot be confirmed after completion of laboratory and imaging examinations, and who agree to undergo bronchoscopy combined with endobronchial ultrasound for pathological biopsy. 4. Informed consent to participate in this clinical study and signed the informed consent.

Exclusion criteria

Exclusion criteria: a. Combined severe cardiopulmonary disease, coagulation disorders, poor tolerance of anaesthesia, combined psychiatric disease or severe neurosis, and other contraindications to bronchoscopy; b. Intraoperative ultrasound findings such as abundant blood flow to the lesion or proximity to large blood vessels that make biopsy risky and inappropriate; c. Inability to co-operate with the study for any reason or in the opinion of the investigator, inappropriate for inclusion in this trial. d. Patients with endobronchial lesions visible to the naked eye on bronchoscopy; e. Persons with missing information.

Design outcomes

Primary

MeasureTime frame
Diagnostic yield;ultrasound visualisation yield;

Secondary

MeasureTime frame
sensitivity;specificity;

Countries

China

Contacts

Public ContactZhongbo Chen

Department of Respiratory and Critical Care Medicine, Key Laboratory of Respiratory Disease of Ningbo, The First Affiliated Hospital of Ningbo University, Ningbo, China.

leonczb@163.com+86 137 7712 5910

Outcome results

None listed

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