A Proof-of-Concept Study to Define the Safety, Efficacy and Feasibility of Cryoanalgesia (Iovera°®) for the Treatment of Pain in Subjects With Morton's Neuroma
Sponsor study identifier
interventional
5
1 country
2
Study Start
August 22, 2022
Actual (reported)Primary Completion
April 22, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 22, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This is a Proof-of-Concept Trial to define the safety, efficacy and feasibility of a cryoanalgesic device (iovera°®) for the treatment of pain in subjects diagnosed with Morton's Neuroma, who have failed conservative therapies.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 22, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 22, 2022
Actual (reported)October 4, 2022
Actual (reported)November 3, 2022
Actual (reported)April 22, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 22, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Pain Management
Numeric Rating Scale (NRS) Pain Intensity Scores completed by subjects three times per day from Day 0 to 3 months post treatment, then NRS weekly through 6 months post treatment. 2. The total daily opioid consumption from Day 0 to 6 months post treatment.
Six Months
Adverse Events and Serious Adverse Events
Six Months
Ambulation
Six Months
Medical Device Feasibility
Six Months
As a Proof of Concept Study, 5 subjects will follow the same protocol, with one cryoanalgesic treatment (iovera°®) with a 6 month clinical follow-up.
iovera°® treatment will be administered via ultrasound guidance to 1-2 branches of the dorsal/digital/proper nerve/s that innervate the Morton's neuroma. The treatment will be completed one time per subject.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
NorthBay Healthcare
Fairfield, California, 94534, United States
NorthBay Healthcare
Vacaville, California, 95687, United States
Cleveland Clinic Communication: Morton's Neuroma: Causes, Symptoms, Diagnois & Treatment. https://my.cleveland clinic.org/health/diseases/15118-mortons-neuroma pages 1-13.
Matthews BG, Hurn SE, Harding MP, Henry RA, Ware RS. The effectiveness of non-surgical interventions for common plantar digital compressive neuropathy (Morton's neuroma): a systematic review and meta-analysis. J Foot Ankle Res. 2019 Feb 13;12:12. doi: 10.1186/s13047-019-0320-7. eCollection 2019.
Sidon E, Rogero R, McDonald E, Daecher A, Shakked R, Pedowitz DI, Fuchs D, Daniel JN, Raikin SM. Prevalence of Neuropathic Pain Symptoms in Foot and Ankle Patients. Foot Ankle Int. 2019 Jun;40(6):629-633. doi: 10.1177/1071100719838302. Epub 2019 Mar 22.
Kevin M Miller, DPM, FACPM, FFPM
NorthBay Healthcare
First Submitted
October 4, 2022
First Posted
November 3, 2022
Study Start
August 22, 2022
Actual (reported)Primary Completion
April 22, 2023
Estimated (date passed)Contact the study team to confirm eligibility.
Thomson L, Aujla RS, Divall P, Bhatia M. Non-surgical treatments for Morton's neuroma: A systematic review. Foot Ankle Surg. 2020 Oct;26(7):736-743. doi: 10.1016/j.fas.2019.09.009. Epub 2019 Nov 2.
Ferkel E, Davis WH, Ellington JK. Entrapment Neuropathies of the Foot and Ankle. Clin Sports Med. 2015 Oct;34(4):791-801. doi: 10.1016/j.csm.2015.06.002.
Ross AB, Jacobs A, Williams KL, Bour RK, Gyftopoulos S. Ultrasound-Guided Injection Treatments Versus Surgical Neurectomy for Morton Neuroma: A Cost-Effectiveness Analysis. AJR Am J Roentgenol. 2022 Feb;218(2):234-240. doi: 10.2214/AJR.21.26419. Epub 2021 Sep 15.
Radnovich R, Scott D, Patel AT, Olson R, Dasa V, Segal N, Lane NE, Shrock K, Naranjo J, Darr K, Surowitz R, Choo J, Valadie A, Harrell R, Wei N, Metyas S. Cryoneurolysis to treat the pain and symptoms of knee osteoarthritis: a multicenter, randomized, double-blind, sham-controlled trial. Osteoarthritis Cartilage. 2017 Aug;25(8):1247-1256. doi: 10.1016/j.joca.2017.03.006. Epub 2017 Mar 20.
Dasa V, Lensing G, Parsons M, Harris J, Volaufova J, Bliss R. Percutaneous freezing of sensory nerves prior to total knee arthroplasty. Knee. 2016 Jun;23(3):523-8. doi: 10.1016/j.knee.2016.01.011. Epub 2016 Feb 10.
Davis T, Loudermilk E, DePalma M, Hunter C, Lindley D, Patel N, Choi D, Soloman M, Gupta A, Desai M, Buvanendran A, Kapural L. Prospective, Multicenter, Randomized, Crossover Clinical Trial Comparing the Safety and Effectiveness of Cooled Radiofrequency Ablation With Corticosteroid Injection in the Management of Knee Pain From Osteoarthritis. Reg Anesth Pain Med. 2018 Jan;43(1):84-91. doi: 10.1097/AAP.0000000000000690.
Poppler LH, Parikh RP, Bichanich MJ, Rebehn K, Bettlach CR, Mackinnon SE, Moore AM. Surgical interventions for the treatment of painful neuroma: a comparative meta-analysis. Pain. 2018 Feb;159(2):214-223. doi: 10.1097/j.pain.0000000000001101.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 22, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 21, 2022
Record last verified: 2022-11
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