Osteoarthritis Clinical Study Information

The Resonator™ device uses electro-magnetic stimulation in order to relieve symptoms of a disorder or disease.

 

Please Download the latest version of Adobe Flash Player.
 

ABOUT US

Our Team

Participate in our research
News Releases

Terms & Conditions of Use
 
 
 
 
   
   
 

Study Information
Contact Information
Test Sites
Purpose & Overview
Worldwide Regulatory Status

Device Information
Device Information
Device Details
Signal Generation
Helmholtz Coils
Determination of Device Safety
Institutional Review Board (IRB)

Study Details
Study Indication
Etiology
Symptoms
Diagnosis
Treatments
Study Treatment Modality: EM Stimulation
Theory of Mechanism of Operation (Part 1)
Theory of Mechanism of Operation (Part 2)
Theory of Mechanism of Operation (Part 3)
EM Stimulation Therapy Rationale
rTMS / TMS
Research (Part 1)
Research (Part 2)
Supporting Materials (Part 1)
Supporting Materials (Part 2)
Supporting Materials (Part 3)
Supporting Materials (Part 4)

Study Design
Procedure Groups
Double-Blind Design
Subjects
Study Test Battery (Part 1)
Study Test Battery (Part 2)
Study Test Battery (Part 3)
Study Test Battery (Part 4)
Pre-Procedure Activities
Inclusion Criteria
Exclusion Criteria
Baseline Assessment

Study Procedures
Standardization Phase
Study Procedure Administration Protocol
During-Procedure Activities
Pre- and Post-Procedure Administration Phases
Post-Procedure Activities
Post-Procedure Activities (Days 15-42)
Statistical Analysis Plan
Secondary Efficacy Outcome
Statistical Methods & Analysis
Safety Analysis
Early Termination Visit
Safety and Confidentiality Issues

 

 

 
   

POST-PROCEDURE ACTIVITIES

IMMEDIATE POST-PROCEDURE ASSESSMENT:
STUDY ENDPOINT START: DAY 14


At the end of the second and final week of procedure administrations (following completion of the 8th and final procedure administration), the subject will return to the sub-PIs test site to record the following measures:

    (i) Lequesne Index of Severity for Osteoarthritis of the Hip

    (ii) Range of Motion of the study hip

    (iii) Erythrocyte sedimentation rate (ESR)

    (iv) High-sensitivity C-Reactive Protein (hs-CRP)

    N.B.: ESR and hs-CRP testing will only require one blood draw.

In addition, the following information will be collected:

    (ii) Unblinding assessment: The subject and the sub-PI will be asked to state whether he or she believes that the subject was assigned to the test group or to the placebo group (Resonator™ device active or inactive), and why.

    (iii) Satisfaction Rating: The subject will be asked to indicate how satisfied he or she is with any perceived overall change in his or her osteoarthritis symptoms from before receiving the first procedure administration with the Resonator™ device (Baseline) to the end of week two (Study Endpoint), using the following five-point scale:

    • Very Satisfied
    • Somewhat Satisfied
    • Neither Satisfied nor Dissatisfied
    • Not Very Satisfied
    • Not at All Satisfied
 
 

4700 140th Ave. N., Suite 101 • Clearwater, FL 33762 • 727-474-3722

HOME | CONTACT US
 
 

Copyright © 2009 by Pico-Tesla. All rights reserved
Sitemap | Privacy Policy & Terms of Use

Website design by DDA Medical

Bookmark and Share    Find Us on Facebook

The Resonator™ device is an Investigational Device limited by Federal (or United States)
law to investigational use. The Resonator™ device is not for sale, nor is the Magneceutical®
Therapy generally available outside of Investigational Review Board (IRB) approved clinical studies.
 

About Us | Our Team | Participate In Our Research | News Releases | Terms & Conditions of Use
Patients & Caregivers | Physicians & Medical Providers | Research & Publications | Press Kit & News | FDA Approval Status
The Device Overview | The Device | User Interface | Safety and Risks | FDA Clearance
Neuromodulation & Electromagnetics Overview | The Resonator™ Device Compared to MRI | The Resonator™ Device Versus TMS and rTMS
The Resonator™ Device Compared to Other Parkinson's Disease Therapies | Theory of Mechanism Overview | Jacobson Resonance™
Parkinson's Disease Study