Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-25 @ 9:53 PM
Study NCT ID:
NCT07178951
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-17
First Post:
2025-06-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neurolysis for the Treatment of Medial Chronic Knee Pain Due to Osteoarthritis
Sponsor:
FUSMobile Inc.
Organization:
Study Overview
Official Title:
Safety and Feasibility of the Neurolyser XR Device for the Treatment of Predominantly Medial Chronic Knee Pain Due to Osteoarthritis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study involves the use of sound waves to block pain signals caused by osteoarthritis of the knee. The sound waves are tightly focused on a specific area of the nerve. The sound waves cause a break in the nerve which carries pain signals. Sound waves transmit through the skin so there is no need for needles. The procedure takes approximately one hour. The device has been approved in Health Canada and Europe for the treatment of lower back pain. This study is to evaluate the use of the same device for people in Canada who have knee pain related to osteoarthritis.
Detailed Description:
The research staff will provide a detailed description of the procedure to the study participant live, allowing time for the participant to ask questions. Once the participant agrees to be in the study, an informed consent form will be signed.
Throughout the study, the research team will closely follow the participants health as it is related to their knee. The participant will have a physical exam of their knee and a pressure algometry test at each onsite visit. They will also rate their pain level on a numerical scale, provide a history of medications taken, and complete several quality of life questionnaires.
The participant will be asked to take their usual pain medication prior to the procedure. The study doctor may also provide additional medication depending on the study participants situation.
The study procedure will last approximately 1 hour. The procedure will take place using a standard X-ray device which allows the study doctor to see the structure of the knee and allow for location of the nerve causing knee pain.
The study device will use ultrasound waves to cause damage to the nerve of the knee where the pain is generated. The goal is to interrupt the pain signal pathway. The ultrasound waves go through the skin so no needles or incisions are needed.
It is unknown how much pain relief the participant will feel or how long it will last. The purpose of the study is to evaluate ten people who have the study procedure. If the study results are good, the manufacturer of the device plans to open up a larger study to involve more study participants.
For participants who have access and a MRI is not contraindicated, a follow-up MRI exam will be performed from day 5 to 7 of the participant's knee.
Throughout the study, the research team will closely follow the participants health as it is related to their knee. The participant will have a physical exam of their knee and a pressure algometry test at each onsite visit. They will also rate their pain level on a numerical scale, provide a history of medications taken, and complete several quality of life questionnaires.
The participant will be asked to take their usual pain medication prior to the procedure. The study doctor may also provide additional medication depending on the study participants situation.
The study procedure will last approximately 1 hour. The procedure will take place using a standard X-ray device which allows the study doctor to see the structure of the knee and allow for location of the nerve causing knee pain.
The study device will use ultrasound waves to cause damage to the nerve of the knee where the pain is generated. The goal is to interrupt the pain signal pathway. The ultrasound waves go through the skin so no needles or incisions are needed.
It is unknown how much pain relief the participant will feel or how long it will last. The purpose of the study is to evaluate ten people who have the study procedure. If the study results are good, the manufacturer of the device plans to open up a larger study to involve more study participants.
For participants who have access and a MRI is not contraindicated, a follow-up MRI exam will be performed from day 5 to 7 of the participant's knee.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: