Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2026-01-01 @ 2:47 PM
Study NCT ID:
NCT01798368
Status:
COMPLETED
Last Update Posted:
2013-07-02
First Post:
2013-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PBASE-system Safety and Tolerability Clinical Investigation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'lastUpdateSubmitDate': '2013-07-01', 'studyFirstSubmitDate': '2013-02-19', 'studyFirstSubmitQcDate': '2013-02-21', 'lastUpdatePostDateStruct': {'date': '2013-07-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in ECG variables', 'timeFrame': 'Approximately 1 hour prior to treatment initiation to 3 hours post treatment termination', 'description': 'ECG variables as documented on continuous recording include heart rate, heart rate variability,T-wave morphology, and occurrence of arrhythmias'}, {'measure': 'Change in Vital signs', 'timeFrame': 'Approximately 1 hour prior to treatment initiation, right before treatment initiation, 10 min after treatment termination and 3 hours after treatment termination', 'description': 'Vital signs measurements include blood pressure, pulse and respiratory rate'}]}, 'conditionsModule': {'conditions': ['Non-patient Volunteers']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate that the treatment does not cause any clinically significant effects that would put patients at risk.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Willing and able to provide written informed consent prior to participation in the clinical investigation\n* Judged by the Investigator as suitable for participation in the study without safety concerns based on medical history, physical examination and laboratory results\n* Age: 18-65 years of age.\n* Gender: Male or female subjects.\n* Negative urine drug screen (amphetamine, benzodiazepines, cocaine, marijuana, metamphetamine, morphine) at screening and Visit 2.\n* 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.\n* Willing and able to comply with all study procedures and restrictions\n\nExclusion Criteria:\n\n* A diagnosis of asthma or chronic obstructive pulmonary disorder.\n* Ongoing respiratory infection including the nasal cavity.\n* Current malignancy of any kind.\n* History of frequent nose bleeds or a condition that increases the risk of excessive bleeding.\n* Pronounced anterior septal deviation or other significant nasal pathology.\n* Known allergy to polyvinylchloride or medicinal liquid paraffin.\n* Ongoing treatment with drugs indicated for respiratory or cardiac disorders.\n* 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.\n* Vital signs with clinically significant deviations that would make the subject unsuitable for the study, as judged by the investigator.\n* Evidence of significant cardiovascular disease defined by the following:\n\n 1. New York Heart Association (NYHA) Class III or IV heart failure;\n 2. Presence of symptomatic coronary artery disease or unstable angina;\n 3. Persistent arrhythmia requiring chronic pharmacotherapy or implantable device;\n 4. Clinically significant abnormalities seen on the screening electrocardiogram as assessed by the investigator;\n* Clinically significant deviations in, hematology (including coagulation parameters aPTT and INR) variables, blood chemistry variables or urinalysis as assessed by the investigator.\n* Positive screening test for HIV or hepatitis B or C\n* Positive alcohol breath test at Visit 1 or at Visit 2.\n* Non-smoker since at least six months at time of screening.\n* 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.\n* Previously treated with radiation on the face\n* Previous radiation therapy to the head or neck regions\n* Previously treated with an implantable stimulator or any implantable device in the head and / or neck\n* Has a recent or repeated history of syncope.\n* Has a recent or repeated history of seizures.\n* Surgery within the past three months, determined by the PI to be clinically relevant.\n* Strenuous exercise within 2 days of Visit 1 or Visit 2.\n* Women who are pregnant or nursing.\n* 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.\n* Received study drug in a clinical trial for an investigational drug within the previous 30 days, or 5 half-lives, whichever is longer.\n* Blood donation or loss of whole blood exceeding 100 mL within 30 days from screening or plasma within 14 days from screening.\n* 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).\n* 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."}, 'identificationModule': {'nctId': 'NCT01798368', 'briefTitle': 'PBASE-system Safety and Tolerability Clinical Investigation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chordate Medical'}, 'officialTitle': 'An Open Label Study to Evaluate the Safety and Tolerability of Nasal Stimulation Using the PBASE System in Non-patient Volunteers', 'orgStudyIdInfo': {'id': 'PS002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PBASE system 2.0', 'interventionNames': ['Device: PBASE system 2.0']}], 'interventions': [{'name': 'PBASE system 2.0', 'type': 'DEVICE', 'armGroupLabels': ['PBASE system 2.0']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chordate Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}