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The RA PROTECTION Study

NCT04306744 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2023-03-30

No results posted yet for this study

Summary

This is a prospective, multi-center, double-blind, randomized, controlled pilot study to assess safety and efficacy of the Vorso PROTECT System in patients who have moderately to severely active rheumatoid arthritis.

Eligible participants will be randomized in a 1:1 ratio of treatment to control (non- therapeutic) group after it has been determined they meet all of the inclusion criteria and none of the exclusion criteria. Both the treatment and control group participants will be asked to use the VORSO System once a day while maintaining a stable dose of methotrexate throughout the 12-week study. Participants will return to the site at 1, 6 and 12 weeks for follow-up testing.

Conditions

Interventions

DEVICE

Vorso PROTECT System

The Vorso PROTECT System is designed to deliver targeted, imperceptible, non-invasive stimulation to the ear to treat the signs and symptoms (e.g., tender and swollen joints, pain, synovitis) of patients with rheumatoid arthritis.

DEVICE

Vorso PROTECT System - Sham (OFF)

Identical device to experimental arm, but the device will not deliver stimulation

Sponsors & Collaborators

  • Nesos Corp

    lead INDUSTRY

Principal Investigators

  • Alan Kivitz, MD · Altoona Center for Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2022-01-21
Completion
2022-01-21
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04306744 on ClinicalTrials.gov