Lumbar SpondylosisNCT06477094
RFA Using Multi-Tined Electrodes vs.Traditional Electrodes for Lumbar Spondylosis
A study testing Stratus Nimbus Electrosurgical RF Multi-Tined Expandable Electrode and Stryker Venom Radiofrequency Cannula in people with Lumbar Spondylosis, run by University of Arkansas at 1 site in United States.
Trial summary
Spondylosis is an anatomical defect of the small facet joints between the spinal vertebrae often due to load bearing and mechanical wear. It is a major contributor to lower back pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Spondylosis
- What is being tested?
- Stratus Nimbus Electrosurgical RF Multi-Tined Expandable Electrode and Stryker Venom Radiofrequency Cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2024to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Greater than 18 years of age
- Presenting with chronic non-radicular lower back pain
- Failure of conservative treatment such as physical therapy or NSAID usage
- Diagnosis of lumbar facet mediated lower back pain by a board-certified chronic pain physician via two sets of prognostic lumbar MBBs with 0.5cc of 0.5% bupivacaine with >80% pain relief
Who cannot join
- History of known coagulopathy
- > 3 American Society of Anesthesiologists Classification
- Pregnancy
- Spinal hardware between L3 and S1
- Allergies to injection medications
- English illiteracy
- Pain improvement following physical therapy or NSAID usage
- Previous history of attempted lumbar RFA
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Aparna Jindal, MD, 3195125259, ajindal@uams.edu
Edward Denton, BS
About this study
Official title: Efficacy of Radiofrequency Ablation Using Multi-Tined Electrodes vs. Traditional Electrodes for Treatment of Lumbar Spondylosis
Spondylosis is an anatomical defect of the small facet joints between the spinal vertebrae often due to load bearing and mechanical wear. It is a major contributor to lower back pain. The current standard of care in patients diagnosed with spondylosis in the lower back is to perform a radiofrequency ablation (RFA) of the lumbar medial branch nerves which carry the pain signals from that region to the brain. RFA accomplishes this by using radio waves transmitted through inserted electrodes. This leads to a temporary lesion or "burn"; stopping the pain signals from being transmitted as as well as changing the pain signals themselves. The electrodes themselves do not heat up but instead cause ions in the surrounding tissue to vibrate and heat up. When performing the procedure at the UAMS pain clinic, one can use the Stryker system with a single electrode end which protrudes out of the cannula or the Stratus Nimbus electrode with two prongs which expand in a "V"; formation along the sides of the cannula. While testing in chicken tissue shows that the latter electrode type produces a larger lesion size, anecdotal evidence suggests that it may lead to longer term pain relief. As such, the choice is currently left up to physician preference as both are FDA approved for use in this condition. This study is trying to assess if the larger lesion size results in a reduction in impairment of activities of daily living due to pain measured by the patient-reported PROMIS (Patient Reported Measurement Information System)-29 questionnaire. The PROMIS-29 is given to all patients who are seen in the UAMS Pain Clinic at initial and follow-up visits. In this study we would like to randomize what electrode and cannula set is used in RFA for patient's who are already going to be receiving the procedure for treatment for their spondylosis. The study team would then compare the PROMIS outcomes between cases that used the Stryker and Stratus Nimbus electrodes at 1,3,6,9 and 12 months. It is hypothesized that the Nimbus electrode will result in a greater reduction and improvement in PROMIS scores for a longer duration than the Stryker electrode.
Read the detailed description
This study is a single center double-blinded prospective randomized clinical trial. Patients will be recruited from the pool of patients seen by the Principal Investigators (PIs) and collaborating physicians in the UAMS pain management clinic through the Department of Anesthesiology. Candidacy for RFA is determined by the standard of care which includes diagnosis of axial low back pain without lower extremity radiation or other primary pain generators. These patients should not have had previous RFA's in the lumbar region before. These patients should receive greater than 80% pain relief following two diagnostic MBBs completed at separate times. In routine care, physicians discuss with patients the risks and benefits associated with the RFA procedure. In order to establish a baseline level of pain, disability, and impairment of daily living, patients are routinely asked to complete the PROMIS-29 questionnaire to the best of their ability. Once patients receive their second MBB they are to return 2 to 4 weeks later for RFA should they meet the necessary 80% pain relief. At the time of the procedure, a simple randomization performed by a staff member not involved in the patient's care, will be used to determine if the patient's procedure will involve the use of the Stratus Nimbus or the Stryker Venom electrode and cannula set. The provider performing the procedure will be made aware of which electrode is to be used. However, patients will be blinded to the group to which they were randomized. Patients will continue with conventional RFA as per standard of care. Patients will then be contacted at 1,3,6, 9, and 12 months for assessment of response to intervention including the PROMIS-29 questionnaire. Scores are then compared to those taken at baseline to determine efficacy of treatment and inform future care.
- Conditions
- Lumbar Spondylosis
- Being tested
- Stratus Nimbus Electrosurgical RF Multi-Tined Expandable Electrode, Stryker Venom Radiofrequency Cannula
- Keywords
- Radiofrequency Ablation, Lower Back Pain, Lumbar Spondylosis
- Medical subject headings
- Spondylosis, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stratus Nimbus Electrosurgical RF Multi-Tined Expandable ElectrodeDevice
Radiofrequency Ablation of Lumbar Medial Branch Nerves using the Stratus Nimbus Electrode
Stryker Venom Radiofrequency CannulaDevice
Radiofrequency Ablation of Lumbar Medial Branch Nerves using the Stryker Venom Cannula
| Study group | Role | What they receive |
|---|---|---|
| Stratus Nimbus | Active comparator | Patients will receive their radiofrequency ablation procedure of the lumbar medial branch nerves with the Stratus Nimbus Electrode. Receives: Device: Stratus Nimbus Electrosurgical RF Multi-Tined Expandable Electrode |
| Stryker Venom | Active comparator | Patients will receive their radiofrequency ablation procedure of the lumbar medial branch nerves with the Stryker Venom Cannula. Receives: Device: Stryker Venom Radiofrequency Cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
PROMIS Outcomes
The PROMIS (Patient Reported Outcomes Measurement Information System) outcomes as reported by the PROMIS-29 questionnaire serve as an indicator for pain severity and impairment of activities of daily living. The PROMIS-29 questionnaire which assess 7 heath domains which include 4 survey items with scores ranging from 0 being no impairment and 5 being the most severe impairment. The questionnaire also assess the patient's pain on a numerical scale from 0 being no pain and 10 being the worst pain experienced by the patient. Both components are then used to assess impairment of daily activities using composite T-scores which are calculated from the raw data. T-Scores between 40-45 is considered mild impairment, 30-40 is considered moderate impairment, and less then 30 is considered severe impairment.
Measured: 0, 1, 3, 6, 9, and 12 months from procedure date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start9 Aug 2024
- Primary completion31 Jul 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Lumbar SpondylosisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single Blinded Randomized Control Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aparna Jindal, MD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06477094
- Sponsor's protocol ID
- 297420
- Status last verified
- Sep 2026
- First submitted
- 20 Jun 2024
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Andersson HI, Ejlertsson G, Leden I, Rosenberg C. Chronic pain in a geographically defined general population: studies of differences in age, gender, social class, and pain localization. Clin J Pain. 1993 Sep;9(3):174-82. doi: 10.1097/00002508-199309000-00004.
PubMed 8219517Schwarzer AC, Aprill CN, Derby R, Fortin J, Kine G, Bogduk N. Clinical features of patients with pain stemming from the lumbar zygapophysial joints. Is the lumbar facet syndrome a clinical entity? Spine (Phila Pa 1976). 1994 May 15;19(10):1132-7. doi: 10.1097/00007632-199405001-00006.
PubMed 8059268Cohen SP, Raja SN. Pathogenesis, diagnosis, and treatment of lumbar zygapophysial (facet) joint pain. Anesthesiology. 2007 Mar;106(3):591-614. doi: 10.1097/00000542-200703000-00024.
PubMed 17325518Lainez Ramos-Bossini AJ, Jimenez Gutierrez PM, Ruiz Santiago F. Efficacy of radiofrequency in lumbar facet joint pain: a systematic review and meta-analysis of placebo-controlled randomized controlled trials. Radiol Med. 2024 May;129(5):794-806. doi: 10.1007/s11547-024-01809-8. Epub 2024 Mar 21.
PubMed 38512629Li SJ, Zhang SL, Feng D. A comparison of pulsed radiofrequency and radiofrequency denervation for lumbar facet joint pain. J Orthop Surg Res. 2023 May 5;18(1):331. doi: 10.1186/s13018-023-03814-5.
PubMed 37143095Cedeno DL, Vallejo A, Kelley CA, Tilley DM, Kumar N. Comparisons of Lesion Volumes and Shapes Produced by a Radiofrequency System with a Cooled, a Protruding, or a Monopolar Probe. Pain Physician. 2017 Sep;20(6):E915-E922.
PubMed 28934795Manchikanti L, Kaye AD, Soin A, Albers SL, Beall D, Latchaw R, Sanapati MR, Shah S, Atluri S, Abd-Elsayed A, Abdi S, Aydin S, Bakshi S, Boswell MV, Buenaventura R, Cabaret J, Calodney AK, Candido KD, Christo PJ, Cintron L, Diwan S, Gharibo C, Grider J, Gupta M, Haney B, Harned ME, Helm Ii S, Jameson J, Jha S, Kaye AM, Knezevic NN, Kosanovic R, Manchikanti MV, Navani A, Racz G, Pampati V, Pasupuleti R, Philip C, Rajput K, Sehgal N, Sudarshan G, Vanaparthy R, Wargo BW, Hirsch JA. Comprehensive Evidence-Based Guidelines for Facet Joint Interventions in the Management of Chronic Spinal Pain: American Society of Interventional Pain Physicians (ASIPP) Guidelines Facet Joint Interventions 2020 Guidelines. Pain Physician. 2020 May;23(3S):S1-S127.
PubMed 32503359Kornick C, Kramarich SS, Lamer TJ, Todd Sitzman B. Complications of lumbar facet radiofrequency denervation. Spine (Phila Pa 1976). 2004 Jun 15;29(12):1352-4. doi: 10.1097/01.brs.0000128263.67291.a0.
PubMed 15187637Bogduk N, Dreyfuss P, Baker R, Yin W, Landers M, Hammer M, Aprill C. Complications of spinal diagnostic and treatment procedures. Pain Med. 2008;9
Carr CM, Plastaras CT, Pingree MJ, Smuck M, Maus TP, Geske JR, El-Yahchouchi CA, McCormick ZL, Kennedy DJ. Immediate Adverse Events in Interventional Pain Procedures: A Multi-Institutional Study. Pain Med. 2016 Dec;17(12):2155-2161. doi: 10.1093/pm/pnw051. Epub 2016 Apr 15.
PubMed 28025351
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Radiofrequency Ablation Using Multi-Tined Electrodes vs. Traditional Electrodes for Treatment of Lumbar Spondylosis
- ClinicalTrials.gov ID
- NCT06477094
- Acronym / sponsor ID
- 297420
- Conditions
- Lumbar Spondylosis
- Keywords
- Radiofrequency Ablation, Lower Back Pain, Lumbar Spondylosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 9 Aug 2024 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 27 Jun 2024 (actual)
- 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.
Spondylosis is an anatomical defect of the small facet joints between the spinal vertebrae often due to load bearing and mechanical wear. It is a major contributor to lower back pain. The current standard of care in patients diagnosed with spondylosis in the lower back is to perform a radiofrequency ablation (RFA) of the lumbar medial branch nerves which carry the pain signals from that region to the brain. RFA accomplishes this by using radio waves transmitted through inserted electrodes. This leads to a temporary lesion or "burn"; stopping the pain signals from being transmitted as as well as changing the pain signals themselves. The electrodes themselves do not heat up but instead cause ions in the surrounding tissue to vibrate and heat up. When performing the procedure at the UAMS pain clinic, one can use the Stryker system with a single electrode end which protrudes out of the cannula or the Stratus Nimbus electrode with two prongs which expand in a "V"; formation along the sides of the cannula. While testing in chicken tissue shows that the latter electrode type produces a larger lesion size, anecdotal evidence suggests that it may lead to longer term pain relief. As such, the choice is currently left up to physician preference as both are FDA approved for use in this condition. This study is trying to assess if the larger lesion size results in a reduction in impairment of activities of daily living due to pain measured by the patient-reported PROMIS (Patient Reported Measurement Information System)-29 questionnaire. The PROMIS-29 is given to all patients who are seen in the UAMS Pain Clinic at initial and follow-up visits. In this study we would like to randomize what electrode and cannula set is used in RFA for patient's who are already going to be receiving the procedure for treatment for their spondylosis. The study team would then compare the PROMIS outcomes between cases that used the Stryker and Stratus Nimbus electrodes at 1,3,6,9 and 12 months. It is hypothesized that the Nimbus electrode will result in a greater reduction and improvement in PROMIS scores for a longer duration than the Stryker electrode.
Detailed description
This study is a single center double-blinded prospective randomized clinical trial. Patients will be recruited from the pool of patients seen by the Principal Investigators (PIs) and collaborating physicians in the UAMS pain management clinic through the Department of Anesthesiology. Candidacy for RFA is determined by the standard of care which includes diagnosis of axial low back pain without lower extremity radiation or other primary pain generators. These patients should not have had previous RFA's in the lumbar region before. These patients should receive greater than 80% pain relief following two diagnostic MBBs completed at separate times. In routine care, physicians discuss with patients the risks and benefits associated with the RFA procedure. In order to establish a baseline level of pain, disability, and impairment of daily living, patients are routinely asked to complete the PROMIS-29 questionnaire to the best of their ability. Once patients receive their second MBB they are to return 2 to 4 weeks later for RFA should they meet the necessary 80% pain relief. At the time of the procedure, a simple randomization performed by a staff member not involved in the patient's care, will be used to determine if the patient's procedure will involve the use of the Stratus Nimbus or the Stryker Venom electrode and cannula set. The provider performing the procedure will be made aware of which electrode is to be used. However, patients will be blinded to the group to which they were randomized. Patients will continue with conventional RFA as per standard of care. Patients will then be contacted at 1,3,6, 9, and 12 months for assessment of response to intervention including the PROMIS-29 questionnaire. Scores are then compared to those taken at baseline to determine efficacy of treatment and inform future care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single Blinded Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| Stratus Nimbus | Active comparator | Device: Stratus Nimbus Electrosurgical RF Multi-Tined Expandable ElectrodePatients will receive their radiofrequency ablation procedure of the lumbar medial branch nerves with the Stratus Nimbus Electrode. |
| Stryker Venom | Active comparator | Device: Stryker Venom Radiofrequency CannulaPatients will receive their radiofrequency ablation procedure of the lumbar medial branch nerves with the Stryker Venom Cannula. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Greater than 18 years of age
- Presenting with chronic non-radicular lower back pain
- Failure of conservative treatment such as physical therapy or NSAID usage
- Diagnosis of lumbar facet mediated lower back pain by a board-certified chronic pain physician via two sets of prognostic lumbar MBBs with 0.5cc of 0.5% bupivacaine with >80% pain relief
Key exclusion criteria (8 listed)
- History of known coagulopathy
- > 3 American Society of Anesthesiologists Classification
- Pregnancy
- Spinal hardware between L3 and S1
- Allergies to injection medications
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 |
|---|---|---|
| Stratus Nimbus Electrosurgical RF Multi-Tined Expandable ElectrodeRadiofrequency Ablation of Lumbar Medial Branch Nerves using the Stratus Nimbus Electrode | Device | Stratus Nimbus |
| Stryker Venom Radiofrequency CannulaRadiofrequency Ablation of Lumbar Medial Branch Nerves using the Stryker Venom Cannula | Device | Stryker Venom |
Primary outcome
PROMIS Outcomes
Time frame: 0, 1, 3, 6, 9, and 12 months from procedure date
The PROMIS (Patient Reported Outcomes Measurement Information System) outcomes as reported by the PROMIS-29 questionnaire serve as an indicator for pain severity and impairment of activities of daily living. The PROMIS-29 questionnaire which assess 7 heath domains which include 4 survey items with scores ranging from 0 being no impairment and 5 being the most severe impairment. The questionnaire also assess the patient's pain on a numerical scale from 0 being no pain and 10 being the worst pain experienced by the patient. Both components are then used to assess impairment of daily activities using composite T-scores which are calculated from the raw data. T-Scores between 40-45 is considered mild impairment, 30-40 is considered moderate impairment, and less then 30 is considered severe impairment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Background: PubMed 8219517Andersson HI, Ejlertsson G, Leden I, Rosenberg C. Chronic pain in a geographically defined general population: studies of differences in age, gender, social class, and pain localization. Clin J Pain. 1993 Sep;9(3):174-82. doi: 10.1097/00002508-199309000-00004.
- Background: PubMed 8059268Schwarzer AC, Aprill CN, Derby R, Fortin J, Kine G, Bogduk N. Clinical features of patients with pain stemming from the lumbar zygapophysial joints. Is the lumbar facet syndrome a clinical entity? Spine (Phila Pa 1976). 1994 May 15;19(10):1132-7. doi: 10.1097/00007632-199405001-00006.
- Background: PubMed 17325518Cohen SP, Raja SN. Pathogenesis, diagnosis, and treatment of lumbar zygapophysial (facet) joint pain. Anesthesiology. 2007 Mar;106(3):591-614. doi: 10.1097/00000542-200703000-00024.
- Background: PubMed 38512629Lainez Ramos-Bossini AJ, Jimenez Gutierrez PM, Ruiz Santiago F. Efficacy of radiofrequency in lumbar facet joint pain: a systematic review and meta-analysis of placebo-controlled randomized controlled trials. Radiol Med. 2024 May;129(5):794-806. doi: 10.1007/s11547-024-01809-8. Epub 2024 Mar 21.
- Background: PubMed 37143095Li SJ, Zhang SL, Feng D. A comparison of pulsed radiofrequency and radiofrequency denervation for lumbar facet joint pain. J Orthop Surg Res. 2023 May 5;18(1):331. doi: 10.1186/s13018-023-03814-5.
- Background: PubMed 28934795Cedeno DL, Vallejo A, Kelley CA, Tilley DM, Kumar N. Comparisons of Lesion Volumes and Shapes Produced by a Radiofrequency System with a Cooled, a Protruding, or a Monopolar Probe. Pain Physician. 2017 Sep;20(6):E915-E922.
- Background: PubMed 32503359Manchikanti L, Kaye AD, Soin A, Albers SL, Beall D, Latchaw R, Sanapati MR, Shah S, Atluri S, Abd-Elsayed A, Abdi S, Aydin S, Bakshi S, Boswell MV, Buenaventura R, Cabaret J, Calodney AK, Candido KD, Christo PJ, Cintron L, Diwan S, Gharibo C, Grider J, Gupta M, Haney B, Harned ME, Helm Ii S, Jameson J, Jha S, Kaye AM, Knezevic NN, Kosanovic R, Manchikanti MV, Navani A, Racz G, Pampati V, Pasupuleti R, Philip C, Rajput K, Sehgal N, Sudarshan G, Vanaparthy R, Wargo BW, Hirsch JA. Comprehensive Evidence-Based Guidelines for Facet Joint Interventions in the Management of Chronic Spinal Pain: American Society of Interventional Pain Physicians (ASIPP) Guidelines Facet Joint Interventions 2020 Guidelines. Pain Physician. 2020 May;23(3S):S1-S127.
- Background: PubMed 15187637Kornick C, Kramarich SS, Lamer TJ, Todd Sitzman B. Complications of lumbar facet radiofrequency denervation. Spine (Phila Pa 1976). 2004 Jun 15;29(12):1352-4. doi: 10.1097/01.brs.0000128263.67291.a0.
- BackgroundBogduk N, Dreyfuss P, Baker R, Yin W, Landers M, Hammer M, Aprill C. Complications of spinal diagnostic and treatment procedures. Pain Med. 2008;9
- Background: PubMed 28025351Carr CM, Plastaras CT, Pingree MJ, Smuck M, Maus TP, Geske JR, El-Yahchouchi CA, McCormick ZL, Kennedy DJ. Immediate Adverse Events in Interventional Pain Procedures: A Multi-Institutional Study. Pain Med. 2016 Dec;17(12):2155-2161. doi: 10.1093/pm/pnw051. Epub 2016 Apr 15.
- 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.
Aparna Jindal, MD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stratus Nimbus Electrosurgical RF Multi-Tined Expandable Electrode and Stryker Venom Radiofrequency Cannula in people with Lumbar Spondylosis, run by University of Arkansas at 1 site in United States.
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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edward Denton, MD (9018323377, edenton@uams.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROMIS Outcomes (time frame: 0, 1, 3, 6, 9, and 12 months from procedure date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06477094, which also lists 10 linked publications.
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 10 Sep 2026.