Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-02-22 @ 4:53 PM
Study NCT ID:
NCT02311660
Status:
UNKNOWN
Last Update Posted:
2017-08-03
First Post:
2014-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vagus Nerve Stimulation in Crohn's Disease
Sponsor:
SetPoint Medical Corporation
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2017-08
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: