Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2026-01-06 @ 1:52 AM
Study NCT ID:
NCT06556693
Status:
RECRUITING
Last Update Posted:
2025-10-29
First Post:
2024-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Janus II Feasibility
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}], 'ancestors': [{'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2034-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-28', 'studyFirstSubmitDate': '2024-08-08', 'studyFirstSubmitQcDate': '2024-08-13', 'lastUpdatePostDateStruct': {'date': '2025-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety through 12 months', 'timeFrame': '12 Months post implant', 'description': 'Serious adverse event related to implant procedure, device, or stimulation'}, {'measure': 'Successful Implantation', 'timeFrame': 'implant procedure', 'description': 'Successful Implantation of dual channel system'}, {'measure': 'Improvement in sleep disordered breathing', 'timeFrame': '12 months post implant', 'description': 'Demonstration of the acute prevention of sleep disordered breathing events during attended sleep study.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'The objectives of this study are to evaluate the feasibility of the remedē® Dual Channel System at implant and overnight sleep studies and to assess chronic safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Severe sleep disordered breathing\n* Expected to tolerate study procedures\n* No heart failure or medically stable heart failure\n\nExclusion Criteria:\n\n* Currently implanted with a neurostimulator to treat sleep disordered breathing without sponsor approval\n* History of severe COPD or pulmonary arterial hypertension\n* Current or previous history of nerve injury or palsy\n* Prior cervical surgeries or radiation treatment to head region\n* Known need for an MRI\n* History of psychosis or severe bipolar disorder\n* Active Infection or sepsis within 30 days of enrollment\n* Currently on kidney dialysis or significantly reduced kidney function\n* Hemoglobin less than 8g/dl\n* Pacemaker dependance\n* New defibrillator or any implantable device or device generator changeout within 30 days prior to study implant or anticipated within the first 12 months\n* Other conditions or anticipated surgical procedure expected to affect ability to complete study procedures\n* Allergy to contrast dye unless can be prophylactically treated\n* Known pregnancy or planning to become pregnant'}, 'identificationModule': {'nctId': 'NCT06556693', 'briefTitle': 'Janus II Feasibility', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zoll Medical Corporation'}, 'officialTitle': 'Janus II: A Feasibility Study to Evaluate Response to Remede Dual Channel System Therapy', 'orgStudyIdInfo': {'id': 'CIP3429'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'interventionNames': ['Device: Dual Channel Stimulation']}], 'interventions': [{'name': 'Dual Channel Stimulation', 'type': 'DEVICE', 'description': 'implant of dual channel stimulation device', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85255', 'city': 'Scottsdale', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shelley Beaver, RC', 'role': 'CONTACT', 'email': 'research@sleeplessinarizona.com', 'phone': '480-745-3547'}, {'name': 'Sriharsha Vajjala, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Insomnia and Sleep Institute of Arizona LLC', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '49519', 'city': 'Wyoming', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Stefanie Davis', 'role': 'CONTACT', 'email': 'Stefanie.Davis@umhwest.org'}, {'name': 'Timothy Daum, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The University of Michigan Health-West', 'geoPoint': {'lat': 42.91336, 'lon': -85.70531}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kalyn Ferguson', 'role': 'CONTACT', 'email': 'Kalyn.Ferguson@osumc.edu'}, {'name': 'Ralph Augostini, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'centralContacts': [{'name': 'Samuel Kolapo', 'role': 'CONTACT', 'email': 'samuel.kolapo@zoll.com', 'phone': '205-441-9519'}, {'name': 'Kathy McPherson', 'role': 'CONTACT', 'email': 'kmcpherson@zoll.com', 'phone': '615-613-6321'}], 'overallOfficials': [{'name': 'Robin Germany, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ZOLL Respicardia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zoll Medical Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}