Clinical trial · Observational
Celsius TCS Hyperthermia System PMCF Trial
Celsius TCS Hyperthermia System Post Market Clinical Follow-Up (PMCF) Trial - Vigilance Registry
NCT02896049CI-TRIAL-00052905withdrawnClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): no inclusion has been performed
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Neoplasms | Solid Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hyperthermia | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Hyperthermia
- description
- treatment with the Celsius42 Hyperthermia System
- interventionNames
- Device: Hyperthermia
Primary outcomes (2)
- measure
- failures of the device as well as failure of persons using the device during treatment
- timeFrame
- one month after treatment
- description
- 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).
- measure
- any injury, harm or medically relevant discomfort occurring for the patients or the staff
- timeFrame
- one month after treatment
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * treatment performed with the Celsius TCS Hyperthermia System Exclusion Criteria: * not applicable -
References
Publications (0)
Data not yet available
No reference posted for this study.