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

SetPoint Medical

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Crohn Disease

Treatments

Device: Cyberonics VNS

Study type

Interventional

Funder types

Industry

Identifiers

NCT02951650

SPM-010

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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