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no inclusion has been performed
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| Name | Class |
|---|---|
| Aix Scientifics | INDUSTRY |
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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.
During this PMCF Trial from each participating center the internal data of all Celsius TCS Hyperthermia devices are collected. The participating centers are obligated to report any device-related failure and Adverse Event (injury to the patient). The center reports together with the device-internal data allows to calculate the failure and the complication rates. It will be analyzed regarding the kind of tumor and the concomitant treatment (radiotherapy and/or chemotherapy). The outcome groups (with/without failure or complication) will be analyzed regarding demographic and treatment parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyperthermia | treatment with the Celsius42 Hyperthermia System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperthermia | Device | treatment with the Celsius42 Hyperthermia System additional to radiotherapy and/or chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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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Inclusion Criteria:
Exclusion Criteria:
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The study will include all treatments performed with the Celsius TCS Hyperthermia System at the participating centers throughout the study period. (Normally these are neoplasm patients treated additionally with radiation and/or chemotherapy.)
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| Name | Affiliation | Role |
|---|---|---|
| Hüseyin Şahinbaş, MD | Praxis-Klinik Hyperthermie | Principal Investigator |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D000084462 | Hyperthermia |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018882 | Heat Stress Disorders |
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| ID | Term |
|---|---|
| D003972 | Diathermy |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D006979 | Hyperthermia, Induced |
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| D014947 | Wounds and Injuries |