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NCT04862117 · ClinicalTrials.gov registry record · NA
Long Term Extension of Safety and Efficacy of Vagus Nerve Stimulator in Patients With Rheumatoid Arthritis (RA)
A NA study of Rheumatoid Arthritis, sponsored by SetPoint Medical Corporation.
- Active
- Registry status
- NA
- Development phase
- 14
- Enrollment target
- 4
- Study locations
NCT04862117: Active NA study of Rheumatoid Arthritis, sponsored by SetPoint Medical Corporation.
NCT04862117 is a NA study of Rheumatoid Arthritis that is active but no longer recruiting, run by SetPoint Medical Corporation. The registered enrollment target is 14 participants, below the 4,691-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (100% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04862117, a NA study of Rheumatoid Arthritis, is active but no longer recruiting, sponsored by SetPoint Medical Corporation.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 14 participants
- Enrollment target
- 4
- Study locations
Study Summary
Long-term extension of a multi-site, first-in-human study to assess safety and efficacy of an active implantable Vagus Nerve Stimulation (VNS) device in adult patients with active moderate-to-severe rheumatoid arthritis who have had an incomplete response or intolerability to at least two biologic and/or targeted synthetic DMARDs having at least two different mechanisms of action
Primary Outcome
Treatment-emergent incidence rates of Adverse Events, Adverse Device Effects, Serious Adverse Events, Serious Adverse Device Effects, Unanticipated Adverse Device Effects, and Unanticipated Serious Adverse Device Effects
Conditions Studied
Interventions
- DEVICE SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway System
Study Locations (4)
Florida
- Arthritis & Rheumatic Disease Specialties - Aventura
- Florida Medical Clinic, PA - Zephyrhills
New York
- Northwell Health - Great Neck
Pennsylvania
- Altoona Center for Clinical Research - Duncansville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2018-07-28 |
| Est. Completion | 2026-12-08 |
| Phase | NA |
What the registry record for NCT04862117 still lists
NCT04862117 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 4,691-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 1 intervention - of which SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway System is the first listed.
NCT04862117 reports a single indexed study location in Florida, New York, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04862117 about?
NCT04862117 is a clinical study titled "Long Term Extension of Safety and Efficacy of Vagus Nerve Stimulator in Patients With Rheumatoid Arthritis (RA)". Long-term extension of a multi-site, first-in-human study to assess safety and efficacy of an active implantable Vagus Nerve Stimulation (VNS) device in adult patients with active moderate-to-severe rheumatoid arthritis who have had an incomplete response or intolerability to at least two biologic a...
What is the current status of trial NCT04862117?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 14 participants. The study started on 2018-07-28. Estimated completion is 2026-12-08.
What conditions does trial NCT04862117 study?
This clinical trial studies the following conditions: Rheumatoid Arthritis.
What interventions are being tested in trial NCT04862117?
The interventions under investigation include: SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway System (DEVICE).
Who is sponsoring clinical trial NCT04862117?
This trial is sponsored by SetPoint Medical Corporation, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04862117 being conducted?
This trial has 4 study locations across Florida, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04862117's enrollment target sits among peer trials
14 190th of 197 higher than 5 of 197 other Rheumatoid Arthritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rheumatoid Arthritis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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