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NCT03437473 · ClinicalTrials.gov registry record · NA

Safety and Efficacy of Vagus Nerve Stimulator in Patients With Rheumatoid Arthritis (RA)

A NA study of Rheumatoid Arthritis, sponsored by SetPoint Medical Corporation.

Completed
Registry status
NA
Development phase
14
Enrollment target
4
Study locations

NCT03437473 is a NA study of Rheumatoid Arthritis that has completed, 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.

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The verdict

NCT03437473, a NA study of Rheumatoid Arthritis, has completed, sponsored by SetPoint Medical Corporation.

COMPLETED
Registry status
NA
Development phase
14 participants
Enrollment target
4
Study locations

Study Summary

Multi-site, first-in-human study to assess safety and efficacy of an active implantable Vagus Nerve Stimulation (VNS) device in 15 adult patients with active moderate-to-severe rheumatoid arthritis who have had an incomplete response or intolerability to at least two different mechanisms of action.

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, P.A. - Zephyrhills

New York

  • Northwell Health Division of Rheumatology - Great Neck

Pennsylvania

  • Altoona Center for Clinical Research - Duncansville

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2018-03-06
Est. Completion 2018-12-10
Phase NA

Sponsor

SetPoint Medical Corporation

4 total trials

What the Registry Record Tells You About NCT03437473

The ClinicalTrials.gov registry entry for NCT03437473 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,691-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (100% lower). The listed sponsor is SetPoint Medical Corporation, which has 4 total studies on file at ClinicalTrials.gov.

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.

NCT03437473 reports 4 study locations spanning 3 distinct geographic areas - top geographies include Florida, New York, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT03437473 about?

NCT03437473 is a clinical study titled "Safety and Efficacy of Vagus Nerve Stimulator in Patients With Rheumatoid Arthritis (RA)". Multi-site, first-in-human study to assess safety and efficacy of an active implantable Vagus Nerve Stimulation (VNS) device in 15 adult patients with active moderate-to-severe rheumatoid arthritis who have had an incomplete response or intolerability to at least two different mechanisms of action.

What is the current status of trial NCT03437473?

This trial is currently completed. It is a NA study. The enrollment target is 14 participants. The study started on 2018-03-06. Estimated completion is 2018-12-10.

What conditions does trial NCT03437473 study?

This clinical trial studies the following conditions: Rheumatoid Arthritis.

What interventions are being tested in trial NCT03437473?

The interventions under investigation include: SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway System (DEVICE).

Who is sponsoring clinical trial NCT03437473?

This trial is sponsored by SetPoint Medical Corporation, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03437473 being conducted?

This trial has 4 study locations across Florida, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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