NL-OMON44525
Completed
Not Applicable
Study of the Safety and Efficacy of Neurostimulation of the Cholinergic Anti-Inflammatory Pathway Using a Vagal Nerve Stimulation Device in Patients with Active Refractory Crohn*s Disease - SPM-007
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Crohn's Disease
- Sponsor
- SetPoint Medical Corporation
- Enrollment
- 3
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\-Male or female subjects aged 18\-75 years, inclusive
- •\-Written informed consent prior to any of the screening procedures
- •\-Diagnosis of Crohn's disease for more than 4 months prior to Week \-4 Visit, with small bowel and/or colonic involvement
- •\-Current evidence of moderately\-to\-severely active disease defined by a Week \-4 Visit Crohn's Disease Activity Index (CDAI) score of 220 to 450,
- •\-Simple Endoscopic Score for Crohn\*s Disease evaluation at baseline showing presence of a minimal ulcer score of 2 or 3 in at least 1 segment
- •\-Levels of fecal calprotectin greater than or equal to 200 microgram/gram feces at Week \-4 Visit
- •\-History of inadequate response and/or intolerance or adverse events to one or more TNF\-alpha inhibitors (e.g., infliximab, adalimumab, or certolizumab pegol) or vedolizumab.
- •\-Female subjects of child\-bearing potential are eligible if not pregnant, not planning to become pregnant during the course of the study, and committed to use of contraceptive methods with a failure rate of less than 1 percent per year
Exclusion Criteria
- •Patients who meet any of the following criteria are not to be enrolled in this study:
- •\-Celiac disease
- •\-Diagnosis of ulcerative or indeterminate colitis
- •\-Enterocutaneous, abdominal or pelvic fistulae with abscesses, or fistulae likely to require surgery during the course of the study period
- •\-Bowel surgery, other than appendectomy, within 12 weeks prior to Week \-4 Visit and/or has planned surgery or deemed likely to need surgery for Crohn's disease during the study period
- •\-Extensive colonic resection, subtotal or total colectomy
- •\-Presence of ileostomies, colostomies or rectal pouches
- •\-Fixed symptomatic stenoses of small bowel or colon
- •\-History of more than 3 small bowel resections or diagnosis of short bowel syndrome
- •\-Use of prohibited medications inside the specified washout period (prior to Week \-4 Visit), and throughout the study.
Outcomes
Primary Outcomes
Not specified
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