PBASE-system Safety and Tolerability Clinical Investigation

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate that the treatment does not cause any clinically significant effects that would put patients at risk.

Official Title
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An Open Label Study to Evaluate the Safety and Tolerability of Nasal Stimulation Using the PBASE System in Non-patient Volunteers

Conditions
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Non-patient Volunteers

Intervention / Treatment
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* Device: PBASE system 2.0


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing and able to provide written informed consent prior to participation in the clinical investigation Judged by the Investigator as suitable for participation in the study without safety concerns based on medical history, physical examination and laboratory results Age: 18-65 years of age. Gender: Male or female subjects. Negative urine drug screen (amphetamine, benzodiazepines, cocaine, marijuana, metamphetamine, morphine) at screening and Visit 2. Female subjects have to be post-menopausal for more than one year or use a highly efficient method of contraception (i.e. a method with less than 1% failure rate [e.g. sterilisation, hormone implants, hormone injections, some intrauterine devices, abstinence, or vasectomised partner]). Oral contraceptives: combined pill (estrogen / progestin) and medium-dose progestin pill (for example desogestrel 75ug) are accepted only in combination with the partner using condoms. Willing and able to comply with all study procedures and restrictions Exclusion Criteria: A diagnosis of asthma or chronic obstructive pulmonary disorder. Ongoing respiratory infection including the nasal cavity. Current malignancy of any kind. History of frequent nose bleeds or a condition that increases the risk of excessive bleeding. Pronounced anterior septal deviation or other significant nasal pathology. Known allergy to polyvinylchloride or medicinal liquid paraffin. Ongoing treatment with drugs indicated for respiratory or cardiac disorders. Any disease, condition (medical or surgical) including allergic, immunological and gastro-intestinal conditions and/or chronic medications which, in the opinion of the investigator, might compromise the study results, or would place the subject at increased risk. Vital signs with clinically significant deviations that would make the subject unsuitable for the study, as judged by the investigator. Evidence of significant cardiovascular disease defined by the following: New York Heart Association (NYHA) Class III or IV heart failure; Presence of symptomatic coronary artery disease or unstable angina; Persistent arrhythmia requiring chronic pharmacotherapy or implantable device; Clinically significant abnormalities seen on the screening electrocardiogram as assessed by the investigator; Clinically significant deviations in, hematology (including coagulation parameters aPTT and INR) variables, blood chemistry variables or urinalysis as assessed by the investigator. Positive screening test for HIV or hepatitis B or C Positive alcohol breath test at Visit 1 or at Visit 2. Non-smoker since at least six months at time of screening. Is currently implanted with an electrical and/or neurostimulator device, including but not limited to cardiac pacemaker, defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant. Previously treated with radiation on the face Previous radiation therapy to the head or neck regions Previously treated with an implantable stimulator or any implantable device in the head and / or neck Has a recent or repeated history of syncope. Has a recent or repeated history of seizures. Surgery within the past three months, determined by the PI to be clinically relevant. Strenuous exercise within 2 days of Visit 1 or Visit 2. Women who are pregnant or nursing. Female subjects: unwilling to use adequate contraceptive measures from the signing of the informed consent until end of the study at the follow-up visit. Received study drug in a clinical trial for an investigational drug within the previous 30 days, or 5 half-lives, whichever is longer. Blood donation or loss of whole blood exceeding 100 mL within 30 days from screening or plasma within 14 days from screening. Excessive intake of alcohol, defined as an average daily intake of greater than three units, or a maximum weekly intake of greater than 21 units ((three units equal 250 ml of 12% alcohol by unit wine). Concurrent condition or risk of non-compliance that, in the investigator's opinion, may affect the interpretation of performance or safety data or which otherwise contraindicates participation in a clinical investigation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PBASE system 2.0<br> | Device: PBASE system 2.0<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ECG variables | ECG variables as documented on continuous recording include heart rate, heart rate variability,T-wave morphology, and occurrence of arrhythmias | Approximately 1 hour prior to treatment initiation to 3 hours post treatment termination | 
| Change in Vital signs | Vital signs measurements include blood pressure, pulse and respiratory rate | Approximately 1 hour prior to treatment initiation, right before treatment initiation, 10 min after treatment termination and 3 hours after treatment termination |