Non-patient VolunteersPhase 1NCT01798368
PBASE-system Safety and Tolerability Clinical Investigation
A Phase 1 study testing PBASE system 2.0 in people with Non-patient Volunteers, run by Chordate Medical.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non-patient Volunteers
- What is being tested?
- PBASE system 2.0
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Apr 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
About this study
Official title: An Open Label Study to Evaluate the Safety and Tolerability of Nasal Stimulation Using the PBASE System in Non-patient Volunteers
The purpose of this study is to demonstrate that the treatment does not cause any clinically significant effects that would put patients at risk.
- Conditions
- Non-patient Volunteers
- Being tested
- PBASE system 2.0
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBASE system 2.0Device
| Study group | Role | What they receive |
|---|---|---|
| PBASE system 2.0 | Experimental | Not described Receives: Device: PBASE system 2.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ECG variables
ECG variables as documented on continuous recording include heart rate, heart rate variability,T-wave morphology, and occurrence of arrhythmias
Measured: 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
Measured: Approximately 1 hour prior to treatment initiation, right before treatment initiation, 10 min after treatment termination and 3 hours after treatment termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-patient VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chordate Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01798368
- Sponsor's protocol ID
- PS002
- Status last verified
- Jul 2013
- First submitted
- 19 Feb 2013
- Last updated
- 2 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study to Evaluate the Safety and Tolerability of Nasal Stimulation Using the PBASE System in Non-patient Volunteers
- ClinicalTrials.gov ID
- NCT01798368
- Acronym / sponsor ID
- PS002
- Conditions
- Non-patient Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Chordate MedicalIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Apr 2013 (actual)
- First posted
- 25 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate that the treatment does not cause any clinically significant effects that would put patients at risk.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PBASE system 2.0 | Experimental | Device: PBASE system 2.0 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (32 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PBASE system 2.0 | Device | PBASE system 2.0 |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PBASE system 2.0 in people with Non-patient Volunteers, run by Chordate Medical.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ECG variables (time frame: Approximately 1 hour prior to treatment initiation to 3 hours post treatment termination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2013.