Ignite Creation Date:
2025-12-24 @ 4:48 PM
Ignite Modification Date:
2025-12-25 @ 2:33 PM
Study NCT ID:
NCT02951650
Status:
UNKNOWN
Last Update Posted:
2017-08-03
First Post:
2016-10-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Long Term Observational Study of a Vagal Nerve Stimulation Device in Crohn's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2018-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-02', 'studyFirstSubmitDate': '2016-10-29', 'studyFirstSubmitQcDate': '2016-10-29', 'lastUpdatePostDateStruct': {'date': '2017-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Crohn's Disease Activity Index", 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': 'Inflammatory Bowel Disease Questionnaire', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['vagus nerve stimulation'], 'conditions': ['Crohn Disease']}, 'descriptionModule': {'briefSummary': "This will be an open label multicenter study of the safety and efficacy of an active implantable VNS device in patients with Crohn's Disease.", 'detailedDescription': "Patients who complete study SPM-007 will be enrolled in this study at the time of the last visit of the preceding study. The assessments at the last visit of the preceding study will also be used as baseline measures for the current study. If the patient has previously discontinued SPM-007 and greater than 30 days have elapsed since the final visit in SPM-007, baseline measures for the current study will be repeated, and an interim medical history will be taken to assess whether any new medical conditions were diagnosed in the time between studies.\n\nThe study will continue until the last patient entered has completed 24 months in this study.\n\nFollow-up visits will occur at 3, 6, 12, 18 and 24 months. A final follow-up visit will occur for all remaining patients at study closure when the final enrolled subject has completed 24 months on study.\n\nAn Interim Visit must be performed a maximum of 1 month after any change in device settings. Interim visits may also be performed at any time at the principal investigator's discretion; either between scheduled visits, or after the patient has completed the Month 24 Visit, if the study is still ongoing."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients must have enrolled in study SPM-007; including patients who either completed that study or withdrew before completion of that study.\n\nExclusion Criteria:\n\nInability to provide informed consent Significant psychiatric illness or substance abuse\n\nAll patients will be excluded who have developed any of these exclusionary conditions during the SMP-007 study, or in the interim between SPM-007 and the Day 0 of SPM-010:\n\n* History of unilateral or bilateral vagotomy\n* History of recurrent vaso-vagal syncope episodes\n* Known obstructive sleep apnea\n* Known history of cardiac rhythm disturbances, atrio-ventricular block of greater than first degree, or cardiac conduction pathway abnormalities other than isolated right bundle branch block or isolated left anterior fascicle block.\n* Significant pharyngeal dysfunction or swallowing difficulties\n* Clinically significant vocal cord damage or hoarseness\n* Other implanted electrically active medical devices (e.g., cardiac pacemakers, automatic implantable cardioverter-defibrillators)\n* Asthma or chronic obstructive pulmonary disease not controlled by medications, or any other disease causing clinically significant dyspnea\n* A greater than or equal to 40 pack-year smoking history\n* Active peptic ulcer disease\n* Patients with a limited life expectancy due to terminal illness'}, 'identificationModule': {'nctId': 'NCT02951650', 'briefTitle': "Long Term Observational Study of a Vagal Nerve Stimulation Device in Crohn's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'SetPoint Medical Corporation'}, 'officialTitle': "Long Term Observational Study of the Safety and Efficacy of an Active Implantable Vagal Nerve Stimulation Device in Patients With Crohn's Disease", 'orgStudyIdInfo': {'id': 'SPM-010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cyberonics VNS', 'description': 'Cyberonics VNS', 'interventionNames': ['Device: Cyberonics VNS']}], 'interventions': [{'name': 'Cyberonics VNS', 'type': 'DEVICE', 'description': 'Vagus nerve stimulation', 'armGroupLabels': ['Cyberonics VNS']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zagreb', 'country': 'Croatia', 'facility': 'Dubrava Hospital', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Humanitas Research Hospital', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Academic Medical Center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska Institute', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': "Geert D'Haens, M.D., Ph.D.", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SetPoint Medical Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}