Celsius TCS Hyperthermia System PMCF Trial

July 21, 2021 updated by: Celsius42 GmbH

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.)

Description

Inclusion Criteria:

  • treatment performed with the Celsius TCS Hyperthermia System

Exclusion Criteria:

  • not applicable -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hyperthermia
treatment with the Celsius42 Hyperthermia System
Device: Hyperthermia
treatment with the Celsius42 Hyperthermia System additional to radiotherapy and/or chemotherapy
Other Names:
  • treatment with the Celsius42 Hyperthermia System

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celsius42 GmbH

Collaborators

Aix Scientifics

Investigators

  • Principal Investigator: Hüseyin Şahinbaş, MD, Praxis-Klinik Hyperthermie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

September 1, 2016

First Submitted That Met QC Criteria

September 9, 2016

First Posted (Estimate)

September 12, 2016

Study Record Updates

Last Update Posted (Actual)

July 27, 2021

Last Update Submitted That Met QC Criteria

July 21, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TD08-200

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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