Status:
COMPLETED
PBASE-system Safety and Tolerability Clinical Investigation
Lead Sponsor:
Chordate Medical
Conditions:
Non-patient Volunteers
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to demonstrate that the treatment does not cause any clinically significant effects that would put patients at risk.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01798368
Start Date
January 1 2013
Last Update
July 2 2013
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