PBASE-system Safety and Tolerability Clinical Investigation

NCT01798368 | Completed Phase 1

• 1 other identifier: PS002
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Non-patient Volunteers

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

PBASE system 2.0

EXPERIMENTAL

Device: PBASE system 2.0

Interventions

PBASE system 2.0 DEVICE

PBASE system 2.0

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chordate Medical: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2013
• First Posted: February 25, 2013
• Study Start: January 1, 2013
• Primary Completion: April 1, 2013
• Last Updated: July 2, 2013

Record last verified: 2013-07