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Celsius TCS Hyperthermia System PMCF Trial

NCT ID: NCT02896049

Last Updated: 2021-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-11-30

Brief Summary

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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.

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Detailed Description

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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

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Solid Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Hyperthermia

treatment with the Celsius42 Hyperthermia System

Hyperthermia

Intervention Type DEVICE

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

Interventions

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Hyperthermia

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

Intervention Type DEVICE

Other Intervention Names

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treatment with the Celsius42 Hyperthermia System

Eligibility Criteria

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Inclusion Criteria

* treatment performed with the Celsius TCS Hyperthermia System

Exclusion Criteria

* not applicable -
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aix Scientifics

INDUSTRY

Sponsor Role collaborator

Celsius42 GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hüseyin Şahinbaş, MD

Role: PRINCIPAL_INVESTIGATOR

Praxis-Klinik Hyperthermie

Other Identifiers

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TD08-200

Identifier Type: -

Identifier Source: org_study_id

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