Long Term Observational Study of a Vagal Nerve Stimulation Device in Crohn's Disease
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Long Term Observational Study of the Safety and Efficacy of an Active Implantable Vagal Nerve Stimulation Device in Patients With Crohn's Disease|
- Crohn's Disease Activity Index [ Time Frame: 24 months ]
- Inflammatory Bowel Disease Questionnaire [ Time Frame: 24 months ]
|Study Start Date:||January 2015|
|Estimated Study Completion Date:||August 2018|
|Estimated Primary Completion Date:||May 2018 (Final data collection date for primary outcome measure)|
Experimental: Cyberonics VNS
Device: Cyberonics VNS
Vagus nerve stimulation
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.
The study will continue until the last patient entered has completed 24 months in this study.
Follow-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.
An 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02951650
|Humanitas Research Hospital|
|Academic Medical Center|
|Principal Investigator:||Geert D'Haens, M.D., Ph.D.||Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|