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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02951650
• Date of registration: 29/10/2016
• Prospective Registration: No
• Primary sponsor: SetPoint Medical Corporation
• Public title: Long Term Observational Study of a Vagal Nerve Stimulation Device in Crohn's Disease
• Scientific title: Long Term Observational Study of the Safety and Efficacy of an Active Implantable Vagal Nerve Stimulation Device in Patients With Crohn's Disease
• Date of first enrolment: January 2015
• Target sample size: 15
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02951650
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

Croatia, Italy, Netherlands, Sweden

Contacts

• Name: Geert D'Haens, M.D., Ph.D.
• Affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Key inclusion & exclusion criteria

Inclusion Criteria:

Patients must have enrolled in study SPM-007; including patients who either completed that
study or withdrew before completion of that study.

Exclusion Criteria:

Inability to provide informed consent Significant psychiatric illness or substance abuse

All 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:

- History of unilateral or bilateral vagotomy

- History of recurrent vaso-vagal syncope episodes

- Known obstructive sleep apnea

- 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.

- Significant pharyngeal dysfunction or swallowing difficulties

- Clinically significant vocal cord damage or hoarseness

- Other implanted electrically active medical devices (e.g., cardiac pacemakers,
automatic implantable cardioverter-defibrillators)

- Asthma or chronic obstructive pulmonary disease not controlled by medications, or any
other disease causing clinically significant dyspnea

- A greater than or equal to 40 pack-year smoking history

- Active peptic ulcer disease

- Patients with a limited life expectancy due to terminal illness



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn Disease

Intervention(s)

Device: Cyberonics VNS

Primary Outcome(s)

Crohn's Disease Activity Index [Time Frame: 24 months]

Secondary Outcome(s)

Inflammatory Bowel Disease Questionnaire [Time Frame: 24 months]

Secondary ID(s)

SPM-010

Source(s) of Monetary Support

Please refer to primary and secondary sponsors