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Safety and Efficacy of Ultrathin Cryobiopsy using Direct Retrieval Through the Channel of the Therapeutic Bronchoscope (Cryo-DiReCT) method for diagnosing interstitial lung disease

Ultrathin Cryobiopsy using Direct Retrieval Through the Channel of the Therapeutic Bronchoscope (Cryo-DiReCT) method for diagnosing interstitial lung disease -CRYO-DIRECTION study- - -CRYO-DIRECTION study-

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000061856
Enrollment
50
Registered
2026-06-10
Start date
2026-06-10
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

interstitial lung disease

Interventions

None listed

Sponsors

Department of Clinical Research, National Hospital Organization Okayama Medical Center, Okayama, Japan
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with pulmonary lesions, such as ground-glass opacities or infiltrative shadows, identified on chest computed tomography (CT), who are scheduled to undergo ultrathin cryobiopsy using a 1.1-mm cryoprobe under a therapeutic bronchoscope to determine the treatment strategy. Age>=20 years. Written informed consent for participation in this study obtained from the patient.

Exclusion criteria

Exclusion criteria: Patients strongly suspected of having lung cancer based on elevated tumor markers in blood tests or imaging findings. Lesions located in the inner one-third of the lung field from the hilum. Patients who require additional bronchoscopic procedures other than bronchoalveolar lavage and cryobiopsy before the examination. Lesions adjacent to major blood vessels. Lesions in which the distance from the planned cryobiopsy site to the pleura is less than 1 cm. Pregnant women or women who may be pregnant. Patients receiving anticoagulant or antiplatelet therapy who cannot discontinue these medications prior to the procedure. Patients with a marked bleeding tendency.

Design outcomes

Primary

MeasureTime frame
Safety (bleeding)

Countries

Japan

Contacts

Public ContactYuki Takigawa

NHO Okayama Medical Center IRB

tacky1024@gmail.com086-294-9911

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026