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Trial record 4 of 4 for:    SetPoint Medical Corporation

Vagus Nerve Stimulation in Crohn's Disease

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02311660
First Posted: December 8, 2014
Last Update Posted: August 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
SetPoint Medical Corporation
  Purpose
This is an open label interventional study using an implantable vagus nerve stimulation device in patients with Crohn's disease who have active disease despite treatment with a tumor necrosis factor (TNF) antagonist drug.

Condition Intervention
Crohn's Disease Device: Vagus Nerve Stimulation Device

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by SetPoint Medical Corporation:

Primary Outcome Measures:
  • Crohn's Disease Activity Index [ Time Frame: Week 16 ]

Secondary Outcome Measures:
  • Simple Endoscopic Score for Crohn's Disease (SES-CD) [ Time Frame: Week 16 ]
  • Inflammatory Bowel Disease Questionnaire (IBDQ) [ Time Frame: Week 16 ]
  • Heart Rate Variability (HRV) [ Time Frame: Week 16 ]
  • Changes in Whole Blood Lipopolysaccharide-Induced TNF Release Assay [ Time Frame: Week 16 ]
  • Serum Inflammation Mediators using Meso Scale Discovery Inflammation Multiplex Assay [ Time Frame: Week 16 ]
    Change in level of each mediator from baseline to Week 16

  • Adverse Events [ Time Frame: Week 16 ]
  • Device Deficiencies meeting the event definition from EN ISO 14155:2011 [ Time Frame: Week 16 ]
    Number of events occurring between first use of the device and Week 16 Visit


Estimated Enrollment: 15
Study Start Date: December 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vagus nerve stimulation
Patients will have an implanted vagus nerve stimulation device.
Device: Vagus Nerve Stimulation Device
Cyberonics VNS System

Detailed Description:

This will be an open-label, multicenter study of the safety, biological activity and clinical outcomes of an active implantable VNS device in patients with active refractory CD.

Patients will sign informed consent prior to screening and will undergo all screening and baseline assessment procedures including endoscopy and endoscopic biopsy prior to planned VNS implantation date. Those who meet all of the inclusion criteria and none of the exclusion criteria will be considered enrolled and will be implanted.

After a minimum of 14 days following the implantation, patients will have their first in-clinic visit (Week 0 Visit), during which they will begin self-delivered once-daily stimulation using the VNS device.

Patients will return for weekly visits between Weeks 1-4, at which time outcomes and safety assessments will be taken. At each visit between weeks 1 and 4, an attempt will be made to increase the output current to the maximum level tolerated. At the Week 4 Visit, another attempt to increase the output current will be made and the daily stimulation time will in addition be incremented by 60 seconds to 2 minutes total.

At the Week 6 Visit safety and outcomes assessments will be taken and another attempt to increase the output current will be made, and the daily stimulation time will in addition be incremented to 5 minutes total.

Patients will return at Week 8, at which time safety and outcomes assessments will be taken. If the patient has not achieved a clinical remission by CDAI, the frequency of stimulations will increase from once daily to 4 times daily.

At Week 12, the patient will return for safety and outcomes assessments. The final study visit will be at the Week 16 Visit, at which time patients will have final primary endpoint safety and outcomes assessments, including a follow-up endoscopy with endoscopic biopsy. If patients terminate the study prior to week 16, every effort will be made to perform all Week 16 Visit procedures during an Early Termination Visit.

Patients who complete the study will have the option to enroll in a long-term extension study. If they do not wish to participate in the extension study they can opt to either have their device permanently inactivated and left in place or have the device surgically explanted.

  Eligibility

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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, inclusive
  • 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 leading to discontinuation of 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:

  • 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. Prohibited medications include the following:

    • TNF antagonists and vedolizumab may continue throughout the study, but treatments should have been given at a stable dose for at least 6 months prior to the screening date and should be maintained at this level throughout the study
    • Use of any natalizumab within 8 weeks
    • Use of glucocorticoids at doses greater than 10 mg prednisone orally QD, or an equivalent dose of other oral or parenteral glucocorticoids within 4 weeks
    • Use of cyclosporine, tacrolimus, sirolimus or mycophenolate mofetil within 4 weeks
    • Use of intravenous antibiotics for Crohn's disease within 4 weeks
    • Use of tube or enteral feeding, or elemental diet within 2 weeks
    • Rectal Treatment: Use of 5-aminosalicylates or corticosteroid enemas or suppositories within 2 weeks
    • Azathioprine, 6-mercaptopurine and methotrexate can be continued throughout the trial. These medications must have been used for >12 weeks, at stable dose for at least 3 weeks prior to the Week -4 Visit.
  • Leukocytopheresis or granulocytopheresis within 2 weeks prior to Week -4 Visit
  • Positive immunoassay for Clostridium difficile at Week -4 Visit
  • Known HIV infection
  • Known active in infection with Hepatitis B Virus or Hepatitis C Virus
  • Current evidence of, or has been treated for a malignancy within the past five years (other than localized basal cell or squamous cell skin cancer, cervical dysplasia, or any cancer which has been fully staged as in situ and has been fully resected)
  • History of evidence of adenomatous colonic polyps that have not been removed.
  • Use of any investigational product within 30 days prior to Week -4 Visit for small molecules, or 8 weeks prior for monoclonal antibodies
  • Significant psychiatric disease or substance abuse
  • 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
  • Pre-existing clinically significant vocal cord damage or hoarseness
  • Previously 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 at time of screening
  • A greater than or equal to 40 pack-year smoking history
  • Active peptic ulcer disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02311660


Locations
Croatia
Clinical Hospital Dubrava
Zagreb, Croatia
Italy
Humanitas Research Hospital
Milano, Italy
Netherlands
Academic Medical Center
Amsterdam, Netherlands
Sweden
Karolinska University Hospital, Solna
Stockholm, Sweden
Sponsors and Collaborators
SetPoint Medical Corporation
Investigators
Principal Investigator: Geert D'Haens, M.D., Ph.D. Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  More Information

Responsible Party: SetPoint Medical Corporation
ClinicalTrials.gov Identifier: NCT02311660     History of Changes
Other Study ID Numbers: SPM-007
First Submitted: December 3, 2014
First Posted: December 8, 2014
Last Update Posted: August 3, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases