Celsius TCS Hyperthermia System PMCF Trial

Celsius TCS Hyperthermia System Post Market Clinical Follow-Up (PMCF) Trial - Vigilance Registry

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02896049

Enrollment

Registered

2016-09-12

Start date

2016-11-30

Completion date

2017-11-30

Last updated

2021-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Neoplasms

Keywords

neoplasms, hyperthermia

Brief summary

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.

Detailed description

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.

Interventions

DEVICEHyperthermia

treatment with the Celsius42 Hyperthermia System additional to radiotherapy and/or chemotherapy

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

Inclusion criteria

* treatment performed with the Celsius TCS Hyperthermia System

Exclusion criteria

* not applicable -

Design outcomes

Primary

Measure	Time frame	Description
failures of the device as well as failure of persons using the device during treatment	one month after 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).
any injury, harm or medically relevant discomfort occurring for the patients or the staff	one month after treatment	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).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026