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Safety evaluation of cryoablation device ICS4 in cryoablation of liver tumors

Safety evaluation of cryoablation device ICS4 in cryoablation of liver tumors - Safety evaluation of cryoablation device ICS4

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000007699
Enrollment
6
Registered
2012-04-09
Start date
2012-04-01
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

liver tumor

Interventions

Cryoablation for liver tumors

Sponsors

School of Medicine, Keio University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Clinical diagnosis of liver tumor. 2. Standard treatments such as resection, TAE, RFA, or chemotherapy are not indicated. 3. Performance status 0 to 2. 4. 20 years old or older. 5. Life expectancy more than 3 months. 6. Informed consent can be obtained.

Exclusion criteria

Exclusion criteria: 1. Coagulopathies. 2. Severe liver cirrhosis. 3. The diameter of a tumor is 7 cm or more, and a tumor total is seven or more. 4. There are vascular invasions or extrahepatic metastases. 5. Bleeding tendencies. 6. Uncontrolled infection. 7. Difficulties in communication. 8. Pregnant woman. 9. Excluded by the attending physician.

Design outcomes

Primary

MeasureTime frame
safety

Secondary

MeasureTime frame
efficacy

Countries

Japan

Outcome results

None listed

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