A prospective observational study on the safety and efficacy of cryobiopsy using an ultrathin cryoprobe and a therapeutic bronchoscope to evaluate endobronchial lesions in patients under conscious sedation

A prospective observational study on the safety and efficacy of cryobiopsy using an ultrathin cryoprobe and a therapeutic bronchoscope to evaluate endobronchial lesions in patients under conscious sedation - Cryobiopsy using an ultrathin cryoprobe and a therapeutic bronchoscope to assess endobronchial lesions

Status

Recruiting

Phases

Phase 3

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000050606

Enrollment

Registered

2023-03-17

Start date

2023-03-23

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Endotracheal or endobronchial lesions

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients under conscious sedation will undergo cryobiopsy using an ultrathin cryoprobe and a therapeutic bronchoscope to evaluate endobronchial lesions 2. 20 years old or more 3. Provision of written informed consent

Exclusion criteria

Exclusion criteria: 1. Any serious, concomitant medical condition 2. The need for a bronchoscopic procedure exploring a non-target lesion in the same setting 3. Prior enrolment in the trial 4. Patients for whom a therapeutic bronchoscope and a 1.1-mm cryoprobe were not used 5. Pregnancy 6. The inability to temporarily interrupt anticoagulant/antiplatelet agents 7. A bleeding tendency

Design outcomes

Primary

Measure	Time frame
1. Safety (bleeding-related)	—

Secondary

Measure	Time frame
1. Safety (other than bleeding-related) 2. Histological diagnostic yield 3. Procedure duration 4. Specimen size 5. Sampling success in terms of the freezing time 6. Biomarker test success rate	—

Countries

Japan

Contacts

Public ContactMasahide Oki

National Hospital Organization Nagoya Medical Center Department of Respiratory Medicine

masahideo@gmail.com052-951-1111

Outcome results