Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2025-12-26 @ 1:39 AM
Study NCT ID:
NCT03559933
Status:
COMPLETED
Last Update Posted:
2021-09-16
First Post:
2018-06-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
PEPNS System Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-06-11', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tmiller@stimdia.com', 'phone': '612.940.3454', 'title': 'Tim Miller', 'organization': 'Stimdia Medical, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected during the therapy period (48 hours) and additional 30-37 days until follow-up.', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment Group: Percutaneous Electrical Phrenic Nerve Stimulation (PEPNS) Therapy', 'description': "Stimdia Medical's pdSTIM L4300 leads will be inserted to lie close to the phrenic nerve in the neck region using ultrasound guidance into every patient who satisfies the Inclusion/Exclusion criteria and is enrolled in the study. Percutaneous electrical phrenic nerve stimulation (PEPNS) therapy will be administered via the Stimdia Medical PEPNS Console for six 2-hour sessions at 8-hour intervals over 48 hours, or until the patient is weaned; whichever comes first.", 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 4, 'seriousNumAffected': 4}], 'seriousEvents': [{'term': 'Patient Death', 'notes': 'Initial medical condition of subject at admission, despite intense medical care lead to subject death. Death unrelated to participation in the trial.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Capture of Left and/or Right Phrenic Nerve', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}, {'units': 'Stimulated Breaths', 'counts': [{'value': '36059', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group: Percutaneous Electrical Phrenic Nerve Stimulation (PEPNS) Therapy', 'description': "Stimdia Medical's pdSTIM L4300 leads will be inserted to lie close to the phrenic nerve in the neck region using ultrasound guidance into every patient who satisfies the Inclusion/Exclusion criteria and is enrolled in the study. Percutaneous electrical phrenic nerve stimulation (PEPNS) therapy will be administered via the Stimdia Medical PEPNS Console for six 2-hour sessions at 8-hour intervals over 48 hours, or until the patient is weaned; whichever comes first."}], 'classes': [{'categories': [{'measurements': [{'value': '96.56', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0125', 'groupIds': ['OG000'], 'paramType': 'Logistic regression model', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '95', 'ciLowerLimit': '93.15', 'ciUpperLimit': '96.66', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0152', 'groupDescription': 'The proportion of successful capture was analyzed using a generalized linear mixed model accounting for subject and stimulation within subject as random effects with multiple observations per subject. The null hypothesis was tested comparing the lower bound of the 98.75% two-sided confidence interval for the estimated percent diaphragm capture rate to the performance goal of 80%. If the lower bound was greater than 80%, the null hypothesis was rejected, and the endpoint was considered met.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Subject and stimulation within subject as random effects with multiple observations per subject was accounted for.'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 48 hours', 'description': 'Capture of the Left and/or Right Phrenic Nerve \\> 80% with an output parameter of \\< 10.5 volts. Capture was defined as diaphragmatic movement as a direct consequence of electrical phrenic nerve stimulation. Capture for this analysis was defined as synchrony of the stimulated breath with the output parameter \\<10.5 volts and Work of Breath between 0.2 and 2.0 Joules/L. Synchrony was achieved if the lag time between start of inspiration and start of stimulation was less than 88 ms. The proportion of successful capture was analyzed using a generalized linear mixed model accounting for subject and stimulation within subject as random effects, and the outcome of capture was yes/no based on whether the stimulation captures the diaphragm with multiple observations per subject.', 'unitOfMeasure': 'percentage of phernic nerve capture', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Stimulated Breaths', 'denomUnitsSelected': 'Stimulated Breaths', 'populationDescription': '10 patients with bilateral lead placement (excluding the initial two patients with left-sided lead placement only)'}, {'type': 'PRIMARY', 'title': 'Percent of Breaths Within Work of Breathing Range', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}, {'units': 'Stimulated Breaths', 'counts': [{'value': '36059', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PEPNS System', 'description': 'The pdSTIM lead will be temporarily inserted near the right and left phrenic nerves and connected to the PEPNS system console in order to stimulate the phrenic nerves and activate the diaphragm on the patients until extubated/removed from mechanical ventilation or until 48 hours has elapsed, whichever comes first.\n\nPEPNS System: PEPNS System therapy will be delivered periodically up to 48 hours or less if patient is no longer being mechanically ventilated.'}], 'classes': [{'categories': [{'measurements': [{'value': '96.77', 'groupId': 'OG000', 'lowerLimit': '96.58', 'upperLimit': '96.95'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 48 hours', 'description': 'Work of Breathing (WOB) kept between 0.2 and 2.0 joules/L for 80% of stimulated breaths. Outcome is measured as a percentage of stimulated breaths that had a WOB between 0.2 joules/L and 2 joules/L and the performance goal was 80%.', 'unitOfMeasure': 'percentage of stimulated breaths', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Stimulated Breaths', 'denomUnitsSelected': 'Stimulated Breaths'}, {'type': 'SECONDARY', 'title': 'Safe and Successful Lead Placement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PEPNS System', 'description': 'The pdSTIM lead will be temporarily inserted near the right and left phrenic nerves and connected to the PEPNS system console in order to stimulate the phrenic nerves and activate the diaphragm on the patients until extubated/removed from mechanical ventilation or until 48 hours has elapsed, whichever comes first.\n\nPEPNS System: PEPNS System therapy will be delivered periodically up to 48 hours or less if patient is no longer being mechanically ventilated.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 48 hours', 'description': 'The percentage of patients who receive safe and successful placement of the multipolar lead in the left and right phrenic nerve utilizing ultrasound guidance will be determined.', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Phrenic Nerve Stimulation Effectiveness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group: Percutaneous Electrical Phrenic Nerve Stimulation (PEPNS) Therapy', 'description': "Stimdia Medical's pdSTIM L4300 leads will be inserted to lie close to the phrenic nerve in the neck region using ultrasound guidance into every patient who satisfies the Inclusion/Exclusion criteria and is enrolled in the study. Percutaneous electrical phrenic nerve stimulation (PEPNS) therapy will be administered via the Stimdia Medical PEPNS Console for six 2-hour sessions at 8-hour intervals over 48 hours, or until the patient is weaned; whichever comes first."}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 48 hours', 'description': 'Phrenic nerve stimulation in synchrony with Mechanical Ventilation breaths will be measured to verify that is occurs with inspiration.', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Serious Device/Procedure Related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Group: Percutaneous Electrical Phrenic Nerve Stimulation (PEPNS) Therapy', 'description': "Stimdia Medical's pdSTIM L4300 leads will be inserted to lie close to the phrenic nerve in the neck region using ultrasound guidance into every patient who satisfies the Inclusion/Exclusion criteria and is enrolled in the study. Percutaneous electrical phrenic nerve stimulation (PEPNS) therapy will be administered via the Stimdia Medical PEPNS Console for six 2-hour sessions at 8-hour intervals over 48 hours, or until the patient is weaned; whichever comes first."}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 48 hours', 'description': 'The percentage of patients who experience one or more serious device/procedure-related adverse events during the study will be reported.', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment Group: Percutaneous Electrical Phrenic Nerve Stimulation (PEPNS) Therapy', 'description': "Stimdia Medical's pdSTIM L4300 leads will be inserted to lie close to the phrenic nerve in the neck region using ultrasound guidance into every patient who satisfies the Inclusion/Exclusion criteria and is enrolled in the study. Percutaneous electrical phrenic nerve stimulation (PEPNS) therapy will be administered via the Stimdia Medical PEPNS Console for six 2-hour sessions at 8-hour intervals over 48 hours, or until the patient is weaned; whichever comes first."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Date of first treatment for first treated patient (P01).', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'comment': 'Date of follow-up visit for last treated patient (P12).', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment Group: Percutaneous Electrical Phrenic Nerve Stimulation (PEPNS) Therapy', 'description': "Stimdia Medical's pdSTIM L4300 leads will be inserted to lie close to the phrenic nerve in the neck region using ultrasound guidance into every patient who satisfies the Inclusion/Exclusion criteria and is enrolled in the study. Percutaneous electrical phrenic nerve stimulation (PEPNS) therapy will be administered via the Stimdia Medical PEPNS Console for six 2-hour sessions at 8-hour intervals over 48 hours, or until the patient is weaned; whichever comes first."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.9', 'spread': '7.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '29.1', 'spread': '6.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Neck Circumference at the Cricoid Cartilage', 'classes': [{'categories': [{'measurements': [{'value': '44.6', 'spread': '5.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeter', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-11-30', 'size': 1996366, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-05-03T20:45', 'hasProtocol': True}, {'date': '2019-03-19', 'size': 456528, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-05-03T20:46', 'hasProtocol': False}, {'date': '2018-11-30', 'size': 168529, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-05-03T20:44', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The pdSTIM Leads are temporarily inserted near the right and left phrenic nerves and connected to the PEPNS System console. Duration of stimulation in PEPNS study is up to 48 hours to allow periodic electrical stimulation in daily sessions until the patients is weaned or 48 hours since initiation of stimulation session has elapsed.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-19', 'studyFirstSubmitDate': '2018-06-08', 'resultsFirstSubmitDate': '2021-05-16', 'studyFirstSubmitQcDate': '2018-06-08', 'lastUpdatePostDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-08-19', 'studyFirstPostDateStruct': {'date': '2018-06-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Capture of Left and/or Right Phrenic Nerve', 'timeFrame': 'Up to 48 hours', 'description': 'Capture of the Left and/or Right Phrenic Nerve \\> 80% with an output parameter of \\< 10.5 volts. Capture was defined as diaphragmatic movement as a direct consequence of electrical phrenic nerve stimulation. Capture for this analysis was defined as synchrony of the stimulated breath with the output parameter \\<10.5 volts and Work of Breath between 0.2 and 2.0 Joules/L. Synchrony was achieved if the lag time between start of inspiration and start of stimulation was less than 88 ms. The proportion of successful capture was analyzed using a generalized linear mixed model accounting for subject and stimulation within subject as random effects, and the outcome of capture was yes/no based on whether the stimulation captures the diaphragm with multiple observations per subject.'}, {'measure': 'Percent of Breaths Within Work of Breathing Range', 'timeFrame': 'Up to 48 hours', 'description': 'Work of Breathing (WOB) kept between 0.2 and 2.0 joules/L for 80% of stimulated breaths. Outcome is measured as a percentage of stimulated breaths that had a WOB between 0.2 joules/L and 2 joules/L and the performance goal was 80%.'}], 'secondaryOutcomes': [{'measure': 'Safe and Successful Lead Placement', 'timeFrame': 'Up to 48 hours', 'description': 'The percentage of patients who receive safe and successful placement of the multipolar lead in the left and right phrenic nerve utilizing ultrasound guidance will be determined.'}, {'measure': 'Phrenic Nerve Stimulation Effectiveness', 'timeFrame': 'Up to 48 hours', 'description': 'Phrenic nerve stimulation in synchrony with Mechanical Ventilation breaths will be measured to verify that is occurs with inspiration.'}, {'measure': 'Serious Device/Procedure Related Adverse Events', 'timeFrame': 'Up to 48 hours', 'description': 'The percentage of patients who experience one or more serious device/procedure-related adverse events during the study will be reported.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Ventilator Induced Diaphragmatic Dysfunction (VIDD)']}, 'referencesModule': {'references': [{'pmid': '32191413', 'type': 'RESULT', 'citation': "O'Rourke J, Sotak M, Curley GF, Doolan A, Henlin T, Mullins G, Tyll T, Omlie W, Ranieri MV. Initial Assessment of the Percutaneous Electrical Phrenic Nerve Stimulation System in Patients on Mechanical Ventilation. Crit Care Med. 2020 May;48(5):e362-e370. doi: 10.1097/CCM.0000000000004256."}, {'pmid': '34625059', 'type': 'DERIVED', 'citation': 'Sotak M, Roubik K, Henlin T, Tyll T. Phrenic nerve stimulation prevents diaphragm atrophy in patients with respiratory failure on mechanical ventilation. BMC Pulm Med. 2021 Oct 8;21(1):314. doi: 10.1186/s12890-021-01677-2.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/32191413/', 'label': 'Initial Assessment of the Percutaneous Electrical Phrenic Nerve Stimulation System in Patients on Mechanical Ventilation'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this feasibility study is to evaluate the safety and performance of the PEPNS System in patients that need to be mechanically ventilated for at least 48 hours and up to 7 days in the Intensive Care Unit (ICU).', 'detailedDescription': "Mechanical ventilation is a life saving technology but can also cause damage to the lungs and diaphragm such as ventilator induced diaphragmatic dysfunction (VIDD). Research has shown that after being on mandatory mechanical ventilation and sedation the diaphragm begins to atrophy within as little as 18 hours. The PEPNS System consists of a console and disposable lead and will be used to stimulate the patient's diaphragm to contract in synchrony with the inspiratory cycle of the ventilator. The proprietary phrenic nerve to diaphragm stimulation (pdSTIM) Lead incorporates multipolar electrodes that align with the left and right phrenic nerves in order to stimulate the nerves to the diaphragm. This feasibility trial will investigate the safety and performance of the PEPNS System as a therapy by stimulating the diaphragm over a 48 hour period to facilitate weaning from the mechanical ventilator. The patient population includes those need to be mechanically ventilated for at least 48 hours and up to 7 days in the ICU."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18 years or older (Adult).\n2. Able and willing to give informed consent or whose legally authorized representative is able and willing to give informed consent.\n3. Subject who in the opinion of the admitting consultant/intensivist is likely to be ventilated for \\> 48 hours from time of recruitment since study treatment will be for up to 48 hours.\n\nExclusion Criteria:\n\n1. Subject has a left ventricular ejection fraction (LVEF) \\< 20%.\n2. Subject unlikely to survive 72 hours due to coexisting medical conditions.\n3. Subject has an implanted pulse generator or implanted electronic device:\n4. Subject has experienced an Acute Myocardial Infarction (AMI) within 72 hours prior to this screening or patient is on high dose inotropic support or subject is deemed to be in cardiogenic shock.\n5. Subject has significant bleeding diathesis, or is at risk of significant haemorrhage, patient is receiving full dose systemic anticoagulation\n6. Subject has a known or suspected phrenic nerve paralysis or neuromuscular or inflammatory muscle diseases where the diaphragm itself may not be functional.\n7. Subject has an active systemic infection or local infection at or around the insertion site. Subject is neutropenic or has signs of significant immunocompromise.\n8. Subject is known or suspected to be pregnant or is lactating.\n9. Subject will be unavailable for, or is unwilling to comply with, follow up requirements of the protocol.\n10. Subject is currently enrolled or is expected to be enrolled in any other study of an investigational drug or device who has received treatment under that protocol with the investigational product during the 30 days prior to screening.\n11. Subject has undergone a surgery or interventional procedure within the neck region aside from placement of an internal jugular (IJ) vein catheter.\n12. Subject has been diagnosed and has been treated for neck cancer within the past 5 years.\n13. Subject is known to have a demonstrated intra cardiac thrombus on echocardiography.\n14. Subject has uncontrolled hyperthyroidism, hypertension.\n15. Subject has had any cerebral ischemic event (Stroke or Transient Ischemic Attack TIA) in the 6-month interval preceding the screening date.\n16. Subject has degenerative nerve disorders such as amyotrophic laterals sclerosis (ALS).\n17. Subject has an elevated hemidiaphragm on chest x-ray.\n18. Subject written informed consent not obtained.'}, 'identificationModule': {'nctId': 'NCT03559933', 'briefTitle': 'PEPNS System Feasibility Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Stimdia Medical Inc.'}, 'officialTitle': 'Percutaneous Electrical Phrenic Nerve Stimulation (PEPNS) System Feasibility Study', 'orgStudyIdInfo': {'id': 'CIP0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PEPNS System', 'description': 'The pdSTIM lead will be temporarily inserted near the right and left phrenic nerves and connected to the PEPNS system console in order to stimulate the phrenic nerves and activate the diaphragm on the patients until extubated/removed from mechanical ventilation or until 48 hours has elapsed, whichever comes first.', 'interventionNames': ['Device: PEPNS System']}], 'interventions': [{'name': 'PEPNS System', 'type': 'DEVICE', 'otherNames': ['pdSTIM'], 'description': 'PEPNS System therapy will be delivered periodically up to 48 hours or less if patient is no longer being mechanically ventilated.', 'armGroupLabels': ['PEPNS System']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Prague', 'country': 'Czechia', 'facility': 'Military University Hospital (ÚVN)', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Dublin', 'country': 'Ireland', 'facility': 'Beaumont Hospital', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}], 'overallOfficials': [{'name': 'Michal M Soták, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Military University Hospital (UVN) Prague'}, {'name': "James O'Rourke, PhD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beaumont Hospital Dublin, Ireland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There will be no patient identifying information on any of the study case reports forms and all patients will only be identified by a study number.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stimdia Medical Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}