NCT02951650

Long Term Observational Study of a Vagal Nerve Stimulation Device in Crohn's Disease

Long Term Observational Study of the Safety and Efficacy of an Active Implantable Vagal Nerve Stimulation Device in Patients With Crohn's Disease

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: SetPoint Medical Corporation · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Crohn Disease

Interventions

Type	Name	Description
DEVICE	Cyberonics VNS	Vagus nerve stimulation

Timeline

• Start date: 2015-01-01
• Primary completion: 2018-05-01
• Completion: 2018-08-01
• First posted: 2016-11-01
• Last updated: 2017-08-03

Locations

4 sites across 4 countries: Croatia, Italy, Netherlands, Sweden