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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02873611
• Other study ID #: CL-001-F1
• Status: Not yet recruiting
• Phase: N/A
• First received: July 24, 2016
• Last updated: August 18, 2016
• Start date: August 2016
• Est. completion date: August 2017

Study information

• Verified date: August 2016
• Source: TPM Medical Systems Ltd.
• Contact: Yehuda Fridman, MD
• Phone: 972-3-7645262
• Email: yehudaf[@]assuta.co.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Estimation of the localization accuracy of the genicular ablation procedure applied for chronic pain suppression

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Chronic Pain
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• MRI
patients will undergo an additional MRI testing of apprx. 0.5-1 hour.

Procedure:
• genicular ablation procedure

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
TPM Medical Systems Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Location and orientation of the relevant genicular nerves based on eye-balling inspection of MRI images by a radiologist		6 months	No