Primary Efficacy Objective The primary efficacy objective is to determine the long-term efficacy of NCAP (Neurostimulation of the Cholinergic Anti-inflammatory Pathway) delivered by the implanted device as assessed by the Crohn*s Disease Activity…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Endpoint:
Change from baseline in CDAI (Crohn*s Disease Activity Index)
Secondary outcome
Secondary Endpoints:
-Change from baseline in total score and sub-scale score for the IBDQ
(Inflammatory Bowel Disease Questionnaire)
-Change from baseline in total score and sub-scale score for the SHS (Short
Health Scale)
Background summary
Description of the Investigational Device
This study will utilize the Cyberonics VNS Systems that were implanted during
study SPM-007. The devices are standard commercially available Cyberonics VNS
System pulse generator and lead units, which were implanted in the same manner
as is usually performed when the device is used for its currently labeled
indications.
Rationale for Study
At the conclusion of study SPM-007 patients are given the option to either have
the implanted device removed, to have the device remain in place but be
permanently inactivated, or to continue to receive active treatments with the
device by participating in the current study. This study will determine the
long-term safety and efficacy of NCAP in patients with Crohn*s Disease who have
participated in study SPM-007, using the Cyberonics devices implanted during
the SPM-007 study.
Study objective
Primary Efficacy Objective The primary efficacy objective is to determine the
long-term efficacy of NCAP (Neurostimulation of the Cholinergic
Anti-inflammatory Pathway) delivered by the implanted device as assessed by the
Crohn*s Disease Activity Index (CDAI) score.
Study design
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. 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.
Intervention
Patients will be asked to delivering vagal nerve stimulator treatments using a
small magnet each day during the study. For other see page 42 'Schedule of
Assessments' of the study protocol and section E6.
Study burden and risks
See Section E of this form.
28368 Constellation Road Suite 300
Valencia, CA 93155
US
28368 Constellation Road Suite 300
Valencia, CA 93155
US
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL49869.018.14 |