Osteoarthritis Clinical Study Information - Pico-Tesla Magnetic Therapies, LLC

		Osteoarthritis Clinical Study Information The Resonator™ device uses electro-magnetic stimulation in order to relieve symptoms of a disorder or disease. Overview Device User Interface Safety and Risks FDA Clearance Overview The Resonator™ Device Compared to Other Magnetic Devices and Parkinson’s Disease Therapies The Device Versus MRI (Magnetic Resonance Imaging) The Device Versus TMS and rTMS The Device Versus Other Parkinson’s Disease Therapies Overview Jacobson Resonance™

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Study Information
Contact Information
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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

STUDY PROCEDURE PROTOCOL

PRE-PROCEDURE ACTIVITIES

SUBJECT GROUP RANDOMIZATION
A fully qualified subject will be randomly assigned to either Procedure Group A or B following the methodology outlined above in the STUDY DESIGN section of the protocol.

STUDY QUALIFICATION EVALUATION
SIGNING OF INFORMED CONSENT FORM
The PI will commence by presenting and reviewing in detail the items in the informed consent form with the individual and answer any questions he or she may have. To proceed, the individual must willingly sign the informed consent form.

ASSIGNMENT OF SUBJECT IDENTIFICATION NUMBER
The subject will be assigned a unique subject identification number based upon his or her order of entry into the study.

Additional information about the informed consent and subject ID number assignment is contained in a later section of the protocol titled, ―SAFETY AND CONFIDENTIALITY ISSUES.

STUDY QUALIFICATION EVALUATION: INCLUSION/EXCLUSION CRITERIA
The following assessment tools from the Study Test Battery will be used during the study qualification evaluation:

The American College of Rheumatology (ACR) Classification Criteria for osteoarthritis of the hip
Kellgren-Lawrence Grading Scale
Radiographic Analysis
Erythrocyte Sedimentation Rate (ESR) Testing
Degree of Pain Rating on the 0-10 Visual Analog Scale (VAS)

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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.