Knee OsteoarthritisNCT02873611
Estimation of the Localization Accuracy of the Genicular Ablation Procedure Applied for Chronic Pain Suppression
A study testing MRI and genicular ablation procedure in people with Knee Osteoarthritis, run by TPM Medical Systems Ltd..
Trial summary
Estimation of the localization accuracy of the genicular ablation procedure applied for chronic pain suppression Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- MRI and genicular ablation procedure
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Estimation of the localization accuracy of the genicular ablation procedure applied for chronic pain suppression
- Conditions
- Knee Osteoarthritis
- Being tested
- MRI, genicular ablation procedure
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
patients will undergo an additional MRI testing of apprx. 0.5-1 hour.
genicular ablation procedureProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| MRI scanning and the genicular ablation | Experimental | patients undergoing both MRI scanning and the genicular ablation procedure. additional MRI testing of apprx. 0.5-1 hour Receives: Device: MRI; Procedure: genicular ablation procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Location and orientation of the relevant genicular nerves based on eye-balling inspection of MRI images by a radiologist
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TPM Medical Systems Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yehuda Fridman, MD, Principal investigator, Assuta MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02873611
- Sponsor's protocol ID
- CL-001-F1
- Status last verified
- Aug 2016
- First submitted
- 24 Jul 2016
- Last updated
- 19 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of the Localization Accuracy of the Genicular Ablation Procedure Applied for Chronic Pain Suppression
- ClinicalTrials.gov ID
- NCT02873611
- Acronym / sponsor ID
- CL-001-F1
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- TPM Medical Systems Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2016
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 19 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Estimation of the localization accuracy of the genicular ablation procedure applied for chronic pain suppression
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI scanning and the genicular ablation | Experimental | Device: MRI, Procedure: genicular ablation procedurepatients undergoing both MRI scanning and the genicular ablation procedure. additional MRI testing of apprx. 0.5-1 hour |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIpatients will undergo an additional MRI testing of apprx. 0.5-1 hour. | Device | MRI scanning and the genicular ablation |
| genicular ablation procedure | Procedure or surgery | MRI scanning and the genicular ablation |
Primary outcome
Location and orientation of the relevant genicular nerves based on eye-balling inspection of MRI images by a radiologist
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yehuda Fridman, MD principal investigator
Assuta MC
Questions about this trial
What is this clinical trial studying?
A study testing MRI and genicular ablation procedure in people with Knee Osteoarthritis, run by TPM Medical Systems Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yehuda Fridman, MD (972-3-7645262, yehudaf@assuta.co.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Location and orientation of the relevant genicular nerves based on eye-balling inspection of MRI images by a radiologist (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2016.