Celsius TCS Hyperthermia System PMCF Trial

NCT02896049 | Withdrawn DMC

• 1 other identifier: TD08-200
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Solid Neoplasms

Keywords

neoplasms; hyperthermia

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Hyperthermia

treatment with the Celsius42 Hyperthermia System

Device: Hyperthermia

Interventions

Hyperthermia DEVICE

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

Also known as: treatment with the Celsius42 Hyperthermia System

Hyperthermia

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.)

You may qualify if:

• treatment performed with the Celsius TCS Hyperthermia System

You may not qualify if:

• not applicable -

Sponsors & Collaborators

• Celsius42 GmbH: lead
• Aix Scientifics: collaborator

MeSH Terms

Conditions

Neoplasms; Hyperthermia

Interventions

Diathermy; Therapeutics

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Hyperthermia, Induced

Study Officials

• Hüseyin Şahinbaş, MD

  Praxis-Klinik Hyperthermie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2016
• First Posted: September 12, 2016
• Study Start: November 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: July 27, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share