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
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

SAFETY ANALYSES

Safety analyses will be based on all subjects who were randomized to procedure group, completed the baseline assessment, and received at least the first study procedure with the Resonator™ device.

Safety will be assessed by evaluating and comparing frequency and incidence of observed and/or reported adverse events between test and placebo procedure groups. A chi-square test with a continuity correction will be performed to compare the percentage of subjects who had adverse events and/or reactions between the test and placebo groups.

Anticipated potential adverse events resulting from use of the Resonator™ device are:

Subjects will record any potential adverse events daily and report these recordings to the PI right away. In addition, formal evaluation of the occurrence of any adverse events will take place at each of a subject‘s test site visits.

The investigator will record the observation or report of any adverse event and assign the relationship to the study intervention on the appropriate case report form in the subject‘s file and will report the occurrence to the governing IRB, if and as appropriate, within 5 days of the reported occurrence, or within 24 hours in the occurrence of a serious adverse event including death.

Adverse events will include any baseline symptoms that increase in duration, frequency, or intensity greater than that which could reasonably be expected given the nature of osteoarthritis.

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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.