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PBASE-system Safety and Tolerability Clinical Investigation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01798368
Recruitment Status : Completed
First Posted : February 25, 2013
Last Update Posted : July 2, 2013
Sponsor:
Information provided by (Responsible Party):
Chordate Medical

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.

Condition or disease Intervention/treatment Phase
Non-patient Volunteers Device: PBASE system 2.0 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: An Open Label Study to Evaluate the Safety and Tolerability of Nasal Stimulation Using the PBASE System in Non-patient Volunteers
Study Start Date : January 2013
Actual Primary Completion Date : April 2013

Arm Intervention/treatment
Experimental: PBASE system 2.0 Device: PBASE system 2.0



Primary Outcome Measures :
  1. Change in ECG variables [ Time Frame: Approximately 1 hour prior to treatment initiation to 3 hours post treatment termination ]
    ECG variables as documented on continuous recording include heart rate, heart rate variability,T-wave morphology, and occurrence of arrhythmias

  2. Change in Vital signs [ Time Frame: Approximately 1 hour prior to treatment initiation, right before treatment initiation, 10 min after treatment termination and 3 hours after treatment termination ]
    Vital signs measurements include blood pressure, pulse and respiratory rate



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

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:

    1. New York Heart Association (NYHA) Class III or IV heart failure;
    2. Presence of symptomatic coronary artery disease or unstable angina;
    3. Persistent arrhythmia requiring chronic pharmacotherapy or implantable device;
    4. 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.
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Responsible Party: Chordate Medical
ClinicalTrials.gov Identifier: NCT01798368    
Other Study ID Numbers: PS002
First Posted: February 25, 2013    Key Record Dates
Last Update Posted: July 2, 2013
Last Verified: July 2013