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
|
patients will undergo an additional MRI testing of apprx.
0.5-1 hour.
|
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
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.