Solid NeoplasmsNCT02896049
Celsius TCS Hyperthermia System PMCF Trial
An observational study of Solid Neoplasms, run by Celsius42 GmbH.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Solid Neoplasms
- What is being tested?
- Hyperthermia
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Nov 2017
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.)
Who may be able to join
- treatment performed with the Celsius TCS Hyperthermia System
Who cannot join
- not applicable -
About this study
Official title: 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.
Read the 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
- Being tested
- Hyperthermia
- Keywords
- neoplasms, hyperthermia
- Medical subject headings
- Neoplasms, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HyperthermiaDevice
Also called treatment with the Celsius42 Hyperthermia System
treatment with the Celsius42 Hyperthermia System additional to radiotherapy and/or chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Hyperthermia | treatment with the Celsius42 Hyperthermia System Receives: Device: Hyperthermia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: one month after treatment
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).
Measured: one month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study startNov 2016
- Primary completionNov 2017
- Study completionNov 2017
Why it stopped: no inclusion has been performed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Celsius42 GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aix Scientifics
- Responsible party
- Sponsor
- Investigators
- Hüseyin Şahinbaş, MD, Principal investigator, Praxis-Klinik Hyperthermie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02896049
- Sponsor's protocol ID
- TD08-200
- Status last verified
- Jul 2021
- First submitted
- 1 Sep 2016
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Celsius TCS Hyperthermia System Post Market Clinical Follow-Up (PMCF) Trial - Vigilance Registry
- ClinicalTrials.gov ID
- NCT02896049
- Acronym / sponsor ID
- TD08-200
- Conditions
- Solid Neoplasms
- Keywords
- neoplasms, hyperthermia
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: no inclusion has been performed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Celsius42 GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Aix Scientifics
- Study start
- Nov 2016
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 12 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyperthermia | – | Device: Hyperthermiatreatment with the Celsius42 Hyperthermia System |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.)
Key inclusion criteria (1 listed)
- treatment performed with the Celsius TCS Hyperthermia System
Key exclusion criteria (1 listed)
- not applicable -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HyperthermiaAlso: treatment with the Celsius42 Hyperthermia Systemtreatment with the Celsius42 Hyperthermia System additional to radiotherapy and/or chemotherapy | Device | Hyperthermia |
Primary outcome
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).
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).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hüseyin Şahinbaş, MD principal investigator
Praxis-Klinik Hyperthermie
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Neoplasms, run by Celsius42 GmbH.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
failures of the device as well as failure of persons using the device during treatment (time frame: one month after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2021; AzTrials last refreshed its copy on 27 Oct 2026.