An open-label, uncontrolled study of ERB ECRYO 2 in tissue removal at the site of obstruction/stenosis

An open-label, uncontrolled study of ERB ECRYO 2 in tissue removal at the site of obstruction/stenosis - J-CRYO 2

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000030492

Enrollment

Registered

2018-01-19

Start date

2018-02-09

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

Central airway stenosis due to intraluminal tumor, which caused dyspnea, hypoxemia, strider and requiring treatment

Interventions

ERBE CRYO2 (a general-purpose cryosurgery unit) will be used in tissue removal at the site of obstruction/stenosis

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients with central airway stenosis due to intraluminal tumor which requires treatment for symptoms, such as dyspnea, hypoxemia, or strider (2) Those who can tolerate bronchoscopy (3) Written consent from the patient or representatives

Exclusion criteria

Exclusion criteria: (1) Unstable angina, or myocardial infarction within 6 months (2) Marked bleeding tendency such as anticoagulant in use (3) AST/ALT >= 100 IU/L (4) Pregnant or possibly pregnant (5) Deemed unsuitable to participate in this study by the principal investigator (PI)/sub-investigators

Design outcomes

Primary

Measure	Time frame
Moderate or severe intraoperative bleeding	—

Secondary

Measure	Time frame
Rate of procedural success. Incidence of adverse events. Percentage of subjects with intraoperative SpO 2 of 95% or less.	—

Countries

Japan

Contacts

Public ContactHIDEO SAKA

Nagoya Medical Center Respiratory Medicine

saka@med.nagoya-u.ac.jp052-951-1111

Outcome results

None listed

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