An open-label, uncontrolled study of ERB ECRYO 2 in tissue removal at the site of obstruction/stenosis
Phase 1
- Conditions
- Central airway stenosis due to intraluminal tumor, which caused dyspnea, hypoxemia, strider and requiring treatment
- Registration Number
- JPRN-UMIN000030492
- Lead Sponsor
- ational Hospital Organization Nagoya Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 28
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Moderate or severe intraoperative bleeding
- Secondary Outcome Measures
Name Time Method Rate of procedural success. Incidence of adverse events. Percentage of subjects with intraoperative SpO 2 of 95% or less.