Prospective, multi-center, single-arm, open-label, observational study for Evaluation of Performance and Safety of the BICOM optima / BICOM optima Mobil device for bioresonance treatment in patients with allergic rhino-conjunctivitis.
Organizational Data
- DRKS-ID:
- DRKS00024523
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2021-03-03
- Last update in DRKS:
- 2022-08-18
- Registration type:
- Retrospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
The BICOM optima/PMCF study is a clinical trial conducted with an already approved medical device, the BICOM optima device for Bioresonance-therapy. Bioresonance-therapy is a method of alternative medicine that uses low-energy electromagnetic waves to treat diseases in humans. The aim of the study is to assess the performance and safety of the BICOM optima device for Bioresonance-therapy in patients with mild to moderate rhinoconjunctivits. As this is an already approved product, patients will receive routine therapy in their doctor's office. In the study, only the data from these routine treatments will be documented, collected and then statistically analysed. In addition, the patients will be asked to answer questionnaires about their quality of life, the use of any allergy medication and the severity of their symptoms. It is planned to enrol 132 patients (32 children from 4 to 11 years, 100 patients from 12 years) in up to 10 medical practices in Germany in the study.
Brief summary in scientific language
The BICOM optima/PMCF study is a prospective, multi-center observational study with a medical device,the BICOM optima, which bears the CE mark and is used within the scope of its intended use and in accordance with the Instructions for Use (IFU). The aim of the PMCF study is to assess the performance and safety pf the BICOM optima for bioresonance therapy in patients with mild to moderate allergic rhinoconjunctivitis. Allergic rhinitis/rhinoconjunctivitis is a type I allergic disease and IgE-mediated inflammation caused by exposure of the nasal mucosa to allergens. Common symptoms of allergic rhinitis are sneezing, a runny, stuffy, itchy nose, coughing, a sore or scratchy throat, itchy watery eyes, frequent headaches and excessive fatigue. Bioresonance therapy is a complementary medical procedure that uses low energy electromagnetic waves to treat illness in humans. Patients are treated according to routine clinical practice. Therefore, in this PMCF study, only the data from these routine treatments will be documented, collected and then statistically analysed. In addition, the patients will fill out questionnaires about their quality of life, their use of allergy medication and their symptoms. It is planned to include 132 patients (32 children from 4 to 11 years, 100 patients from 12 years) in up to 10 medical practices in Germany in the study.
Health condition or problem studied
- ICD10:
- J30 - Vasomotor and allergic rhinitis
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 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 duration of the allergy treatment period (treatment phase) is a minimum of 3 to a maximum of 13 weeks, adapted to the patient's response to the therapy.
Endpoints
- Primary outcome:
- -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 outcome:
- - 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.
Study Design
- Purpose:
- Treatment
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- Doctor's practice Neureichenau
- Doctor's practice Aachen
- Doctor's practice Wedemark
- Doctor's practice Vohenstrauß
- Doctor's practice Göttingen
- Doctor's practice Westerstede
- Doctor's practice Rheinberg
- Doctor's practice Düsseldorf
- Doctor's practice Neumarkt in der Oberpfalz
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2021-01-25
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2022-01-10
- Target Sample Size:
- 132
- Final Sample Size:
- 127
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 4 Years
- Maximum Age:
- no maximum age
- Additional 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.
Addresses
Primary Sponsor
- Address:
- Regumed- Regulative Medizintechnik GmbHReiko WollenzinRobert-Koch-Straße 1a82152 PlaneggGermany
- Telephone:
- +49 (0) 174 9080940
- Fax:
- + 49 (0) 89 854 61-03
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.regumed.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- No
Contact for Scientific Queries
- Address:
- Regumed- Regulative Medizintechnik GmbHReiko WollenzinRobert-Koch-Straße 1a82152 PlaneggGermany
- Telephone:
- +49 (0) 174 9080940
- Fax:
- +49 (0) 89 / 854 61-03
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.regumed.de
Contact for Public Queries
- Address:
- Regumed- Regulative Medizintechnik GmbHReiko WollenzinRobert-Koch-Straße 1a82152 PlaneggGermany
- Telephone:
- +49 (0) 174 9080940
- Fax:
- +49 (0) 89 / 854 61-03
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.regumed.de
Principal Investigator
- Address:
- Regumed- Regulative Medizintechnik GmbHReiko WollenzinRobert-Koch-Straße 1a82152 PlaneggGermany
- Telephone:
- +49 (0) 174 9080940
- Fax:
- +49 (0) 89 / 854 61-03
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.regumed.de
Sources of Monetary or Material Support
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- Regumed- Regulative Medizintechnik GmbHRobert-Koch-Straße 1a82152 PlaneggGermany
- Telephone:
- +49 (0) 89 / 854 61-01
- Fax:
- +49 (0) 89 / 854 61-03
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.regumed.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Ärztekammer NordrheinTersteegenstr. 940474 DüsseldorfGermany
- Telephone:
- +49-211-43021581
- Fax:
- +49-211-43021585
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2020-11-20
- Ethics committee number:
- 2020393
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2021-01-20
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry