Solid Neoplasms Clinical Trial
Official title:
Celsius TCS Hyperthermia System Post Market Clinical Follow-Up (PMCF) Trial - Vigilance Registry
NCT number | NCT02896049 |
Other study ID # | TD08-200 |
Secondary ID | |
Status | Withdrawn |
Phase | |
First received | |
Last updated | |
Start date | November 2016 |
Est. completion date | November 2017 |
Verified date | July 2021 |
Source | Celsius42 GmbH |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Based on the basic data of all patients foreseen for a local hyperthermia in the participating centers the failure rate (of the Celsius TCS Hyperthermia System) and the complication rate (injury to the patients) will be recorded.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | November 2017 |
Est. primary completion date | November 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: - treatment performed with the Celsius TCS Hyperthermia System Exclusion Criteria: - not applicable - |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Celsius42 GmbH | Aix Scientifics |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | failures of the device as well as failure of persons using the device during treatment | Based on the risk analysis the failures occurring during treatment will be classified and their frequency will be evaluated. This will be done using the investigators' judgment regarding severity of the failures (as minor, moderate, severe). | one month after treatment | |
Primary | any injury, harm or medically relevant discomfort occurring for the patients or the staff | Based on the risk analysis the injuries occurring during treatment will be classified and their frequency will be evaluated. This will be done using the investigators' judgment regarding severity of the failures (as minor, moderate, severe). | one month after treatment |
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