Celsius TCS Hyperthermia System PMCF Trial

Solid Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02896049
• Other study ID #: TD08-200
• Status: Withdrawn
• Start date: November 2016
• Est. completion date: November 2017

Study information

• Verified date: July 2021
• Source: Celsius42 GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn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 -

Related Conditions & MeSH terms

• Fever
• Solid Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Celsius42 GmbH	Aix Scientifics

Outcome

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