Appendix 7 - Patient Consent
ONCOTHERMIA SHOULD NOT BE USED BY PATIENTS UNTIL THERE HAS BEEN A COMPLETE DISCUSSION
OF THE RISKS AND WRITTEN INFORMED CONSENT HAS BEEN OBTAINED.
IMPORTANT INFORMATION AND WARNING
PATIENT’S CONSENT
My,_____________________________, treatment with ONCOTHERMIA has been personally described
to me by Dr. _____________________________________.
The following points of information, among others, have been specifically discussed and made
clear and I have had the opportunity to ask any questions concerning this information:
1. I, ____________________________(patient's name) understand that ONCOTHERMIA is used to
treat certain types of tumors (malignant and benign) and my physician has told me that I
am this type of patient.
Initials: ________________________
2. I understand that there is a risk of surface or adipose erythematic reaction, sometimes
burn-injury, by using ONCOTHERMIA.
Initials:________________________
3. I understand that there are no laboratory tests that will predict the success of the
treatment
Initials:________________________
4. I understand that I must immediately report any unusual
symptoms to Dr. _________________________________ and be especially aware of persistent
nausea, fatigue, lethargy, decreased appetite, itchiness, pain, etc.
Initials:________________________
I now authorize Dr. ________________________ to start my treatment with ONCOTHERMIA; OR, if
my treatment has already begun with ONCOTHERMIA, to continue the treatment.
Patient's Name: ________________________________________________
Address: ________________________________________________
________________________________________________
Telephone: ________________________________________________
PHYSICIAN STATEMENT: I have fully explained to the patient, ______________________________, the
nature and purpose of the treatment with ONCOTHERMIA and the potential risks associated with
that treatment. I have asked the patient if he/she has any questions regarding this treatment or
the risks and have answered those questions to the best of my ability. I also acknowledge that I
have read and understand the prescribing information listed above.
____________________________________________________________________________________________
Physician Date
NOTE TO PHYSICIAN: It is strongly recommended that you retain a signed copy of the informed
consent with the patient's medical records.
SUPPLY OF PATIENT CONSENT FORMS: A supply of "Patient's Consent" forms as printed above, is
available, free of charge from Oncotherm GmbH, Belgische Allee 9, D-53842, Troisdorf , Germany
(info@oncotherm.de) Phone: +49-2241-319-920
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