Estimation of the Localization Accuracy of the Genicular Ablation Procedure Applied for Chronic Pain Suppression

August 18, 2016 updated by: TPM Medical Systems Ltd.
Estimation of the localization accuracy of the genicular ablation procedure applied for chronic pain suppression

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged 18 years and older.
  • Diagnosed with primary degenerative osteoarthritis.
  • Complaining of knee pains
  • Patients clinically eligible for genicular nerve ablation procedure non-electively based on physical examination
  • Patient signed ICF

Exclusion Criteria:

  • Co-morbidities: patient suffers from neuropathy, bony tumors, traumatic fractures and DM.
  • Claustrophobic or failing cooperativity assessment of laying still during long MRI scans
  • Pregnancy or pregnancy suspicion
  • Enrolled in concurrent studies that may confound the results of this study
  • Clinical condition that in the investigator's opinion would not allow the subject to complete the study, e.g., tremor, extreme obesity, mental disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MRI scanning and the genicular ablation
patients undergoing both MRI scanning and the genicular ablation procedure. additional MRI testing of apprx. 0.5-1 hour
Device: MRI
patients will undergo an additional MRI testing of apprx. 0.5-1 hour.
Procedure: genicular ablation procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Location and orientation of the relevant genicular nerves based on eye-balling inspection of MRI images by a radiologist
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TPM Medical Systems Ltd.

Investigators

  • Principal Investigator: Yehuda Fridman, MD, Assuta MC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

August 1, 2017

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

July 24, 2016

First Submitted That Met QC Criteria

August 18, 2016

First Posted (Estimate)

August 19, 2016

Study Record Updates

Last Update Posted (Estimate)

August 19, 2016

Last Update Submitted That Met QC Criteria

August 18, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL-001-F1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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