Safety cofirmatory study for Percutaneous cryoablation of vascular malformations
- Conditions
- vascular malformation
- Registration Number
- JPRN-UMIN000012194
- Lead Sponsor
- Okayama University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 9
Not provided
1) Under 13 years old. 2) Patients have severe comorbidities as follows: a. Uncontroled malignant tumor. b. Serious lung disease. c. Serious heart trouble. d. Serious liver disease. e. Severe active inflammation and infectious disease. f. Poor control diabetes. g. Immunocompromised state including the whole steroid therapy. h. Case having complications considered to disturb completion of the cryoablation. 4) Past history of radiation exposure to the lesion. 5) Probe insertion can't be performed safely. 6) Clinical clear bleeding tendency (PT-INR >=1.5) 7) Drugs such as antiplatelet agent, anticoagulant, thrombolytic agent can't be ceased temporarily. 8) Being pregnant or may be pregnant. 9) Considered unsuitable for being enrolled in this clinical trial by a attending physician.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse Events
- Secondary Outcome Measures
Name Time Method