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

Primary Purpose

Crohn Disease

Status
Unknown status
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Cyberonics VNS
Sponsored by
SetPoint Medical Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn Disease focused on measuring vagus nerve stimulation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Dubrava Hospital
  • Humanitas Research Hospital
  • Academic Medical Center
  • Karolinska Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cyberonics VNS

Arm Description

Cyberonics VNS

Outcomes

Primary Outcome Measures

Crohn's Disease Activity Index

Secondary Outcome Measures

Inflammatory Bowel Disease Questionnaire

Full Information

First Posted
October 29, 2016
Last Updated
August 2, 2017
Sponsor
SetPoint Medical Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02951650
Brief Title
Long Term Observational Study of a Vagal Nerve Stimulation Device in Crohn's Disease
Official Title
Long Term Observational Study of the Safety and Efficacy of an Active Implantable Vagal Nerve Stimulation Device in Patients With Crohn's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
May 2018 (Anticipated)
Study Completion Date
August 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SetPoint Medical Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease
Keywords
vagus nerve stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cyberonics VNS
Arm Type
Experimental
Arm Description
Cyberonics VNS
Intervention Type
Device
Intervention Name(s)
Cyberonics VNS
Intervention Description
Vagus nerve stimulation
Primary Outcome Measure Information:
Title
Crohn's Disease Activity Index
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Inflammatory Bowel Disease Questionnaire
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geert D'Haens, M.D., Ph.D.
Organizational Affiliation
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dubrava Hospital
City
Zagreb
Country
Croatia
Facility Name
Humanitas Research Hospital
City
Milan
Country
Italy
Facility Name
Academic Medical Center
City
Amsterdam
Country
Netherlands
Facility Name
Karolinska Institute
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

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

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