J30
Conditions
Interventions
Group 1: Patients usually undergo up to 2 preparatory sessions, a minimum of 3 and a maximum of 8 BICOM bioresonance allergy treatment sessions with treatment-free intervals of one to two weeks. The d
Sponsors
Regumed- Regulative Medizintechnik GmbH
Eligibility
Sex/Gender
All
Age
4 Years to No maximum
Inclusion criteria
Inclusion criteria: Based on clinical practice: (a) symptomatic seasonal or persistent allergic rhino-conjunctivitis without severe asthma b) patient with mild to moderate allergic symptoms c) The therapist expects that treatment will usually include two preparatory sessions and at least three allergy-specific sessions within 15 weeks. d) Patients 4 years and older e) Signed written informed consent to participate in this clinical trial and willingness and ability to participate.
Exclusion criteria
Exclusion criteria: a) Psychiatric illness and/or inability to give informed consent. b) Off-label use (use not within the IFU). c) Exclusion of patients due to contraindications in the IFU.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Mean weekly symptom score: This score is recorded from the second session of allergy treatment until one week after the last allergy treatment within the study and compared to the baseline score. A maximum of 8 allergy treatments with BICOM bioresonance therapy will be considered. The primary safety endpoints: -Adverse Device Effect (ADE), medical device and/or procedure related. -Serious Adverse Device Effects (SADE), medical device and/or procedure-related | — |
Secondary
| Measure | Time frame |
|---|---|
| - Mean quality of life score measured with a questionnaire - Mean need for medication - Mean acute symptom burden at the start of the therapy session - assessed by the investigator recorded from the second allergy treatment session until one week after the last allergy treatment within the study with a maximum of 8 measurements compared to baseline. | — |
Countries
Germany
Contacts
Public ContactReiko Wollenzin
Regumed- Regulative Medizintechnik GmbH
Outcome results
None listed