ong Term Observational Study of the Safety and Efficacy of an Active Implantable Vagal Nerve Stimulation Device in Patients with Crohn*s Disease

Completed

• Conditions: Crohn's Disease; Inflammatory Bowel Disease; 10017969

• Registration Number: NL-OMON47080
• Lead Sponsor: SetPoint Medical Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 3

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

Patients who meet any of the following criteria are not to be enrolled in
this study:
* 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:
o History of unilateral or bilateral vagotomy
o History of recurrent vaso-vagal syncope episodes
o Known obstructive sleep apnea
o Known history of cardiac rhythm disturbances, atrioventricular block of greater than first degree, or cardiac conduction pathway abnormalities other than isolated right bundle branch block or isolated left anterior fascicle block.
o Significant pharyngeal dysfunction or swallowing difficulties
o Clinically significant vocal cord damage or hoarseness
o Other implanted electrically active medical devices (e.g., cardiac pacemakers, automatic implantable cardioverterdefibrillators)
o Asthma or chronic obstructive pulmonary disease not controlled by medications, or any other disease causing clinically significant dyspnea
o A greater than or equal to 40 pack-year smoking history
o Active peptic ulcer disease
o Patients with a limited life expectancy due to terminal illness.
* If the patient has previously discontinued SPM-007 and greater than 30 days have elapsed since the final visit in SPM-007, the interim history including medical history, adverse events, device deficiencies, and concomitant medications will be assessed to determine if these preclude safe enrollment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Endpoint:<br /><br>Change from baseline in CDAI (Crohn*s Disease Activity Index)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Endpoints:<br /><br>-Change from baseline in total score and sub-scale score for the IBDQ<br /><br>(Inflammatory Bowel Disease Questionnaire)<br /><br>-Change from baseline in total score and sub-scale score for the SHS (Short<br /><br>Health Scale) </p><br>