Ignite Creation Date:
2024-05-06 @ 3:09 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04539964
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-28
First Post:
2020-08-31
Brief Title:
Vagus Nerve Stimulation for Moderate to Severe Rheumatoid Arthritis
Sponsor:
SetPoint Medical Corporation
Organization:
SetPoint Medical Corporation
Study Overview
Official Title:
Vagus Nerve Stimulation Using the SetPoint System for Moderate to Severe Rheumatoid Arthritis The RESET-RA Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
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:
RESET-RA
Brief Summary:
The RESET-RA study will assess the safety and efficacy of the SetPoint System study device for the treatment of adult patients with active moderate to severe rheumatoid arthritis who have had an inadequate response or intolerance to biologic or targeted synthetic Disease-Modifying Anti-Rheumatic Drugs DMARDs The study device contains a miniaturized stimulator implant that is surgically placed under general anesthesia on the vagus nerve through a small incision on the left side of the neck implant procedure The study will enroll 250 subjects at 40 sites All eligible subjects will undergo the implant procedure Half of the subjects will receive active stimulation treatment and the other half will receive non-active stimulation control After completing primary endpoint assessments at Week 12 there will be a one-way crossover of control subjects to active stimulation and a 180-week open-label follow-up with all subjects treatment and control receiving active stimulation to evaluate long-term safety
Detailed Description:
The RESET-RA study is an operationally seamless 2-stage randomized double-blind sham-controlled multicenter pivotal study enrolling 250 subjects at 40 study centers across the US The study will assess the safety and efficacy of the SetPoint System study device for the treatment of adult patients with active moderate to severe rheumatoid arthritis RA who have had an inadequate response loss of response or intolerance to biologic or targeted synthetic Disease-Modifying Anti-Rheumatic Drugs DMARDs The study device contains a miniaturized stimulator implant that is surgically implanted inside the left side of the neck on the vagus nerve implant procedure The implant delivers a small amount of electricity stimulation to the nerve All eligible subjects will undergo the surgery under general anesthesia Half of the subjects will receive active stimulation the treatment group and the other half will receive non-active stimulation the control group Stimulation will be delivered for 1 min once per day for 12 weeks After completing primary endpoint assessments at Week 12 there will be a one-way crossover of control subjects to active stimulation and a 180-week open-label follow-up with all subjects treatment and control receiving active stimulation to evaluate long-term safety Blinding will be maintained until the last enrolled and randomized subject in Stage 2 completes Week 12 assessments and the study database is locked
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None