Prospective, multi-center, single-arm, open-label, observational study forEvaluation of Performance and Safety of the BICOM optima / BICOMoptima Mobil device for bioresonance treatment in patients with allergicrhino-conjunctivitis.
Completed
- Conditions
- J30Vasomotor and allergic rhinitis
- Registration Number
- DRKS00024523
- Lead Sponsor
- Regumed- Regulative Medizintechnik GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 127
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
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.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method -Mean weekly symptom score:<br>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. <br>A maximum of 8 allergy treatments with BICOM bioresonance therapy will be considered. <br><br>The primary safety endpoints:<br>-Adverse Device Effect (ADE), medical device and/or procedure related.<br>-Serious Adverse Device Effects (SADE), medical device and/or procedure-related<br>
- Secondary Outcome Measures
Name Time Method - Mean quality of life score measured with a questionnaire<br>- Mean need for medication<br>- Mean acute symptom burden at the start of the therapy session<br>- assessed by the investigator<br>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.<br><br><br>