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Celsius TCS Hyperthermia System PMCF Trial

Sponsor
Celsius42 GmbH (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT02896049
Collaborator
Aix Scientifics (Industry)
0
Enrollment
12
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Hyperthermia

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 Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
0 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Celsius TCS Hyperthermia System Post Market Clinical Follow-Up (PMCF) Trial - Vigilance Registry
Study Start Date :
Nov 1, 2016
Actual Primary Completion Date :
Nov 1, 2017
Actual Study Completion Date :
Nov 1, 2017

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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).

    2. 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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • treatment performed with the Celsius TCS Hyperthermia System
    Exclusion Criteria:
    • not applicable -

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Celsius42 GmbH
    • Aix Scientifics

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Celsius42 GmbH
    ClinicalTrials.gov Identifier:
    NCT02896049
    Other Study ID Numbers:
    • TD08-200
    First Posted:
    Sep 12, 2016
    Last Update Posted:
    Jul 27, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Celsius42 GmbH
    neoplasms
    hyperthermia
    Additional relevant MeSH terms:
    Hyperthermia
    Fever

    Study Results

    No Results Posted as of Jul 27, 2021