NCT02896049

Celsius TCS Hyperthermia System PMCF Trial

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

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Celsius42 GmbH · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Neoplasms

Interventions

Type	Name	Description
DEVICE	Hyperthermia	treatment with the Celsius42 Hyperthermia System additional to radiotherapy and/or chemotherapy

Timeline

• Start date: 2016-11-01
• Primary completion: 2017-11-01
• Completion: 2017-11-01
• First posted: 2016-09-12
• Last updated: 2021-07-27