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INJECTABLE COLD ENERGY THERAPY for the MANAGEMENT of CHRONIC PAIN ASSOCIATED with OSTEOARTHRITIS of the KNEE (ICE)

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Brixton Biosciences, Inc.

Status

Enrolling

Conditions

Osteoarthritis (OA) of the Knee

Treatments

Drug: Triamcinolone acetate
Device: Neural Ice

Study type

Interventional

Funder types

Industry

Identifiers

NCT06700109
BXT-786-KPM-03

Details and patient eligibility

About

The goal of this clinical trial is to evaluate the effectiveness of Neural Ice in the treatment of knee osteoarthritis in adults aged 22-80 years. Participants will attend study visits and complete subject diaries. Participants will be followed for 6 months after study procedure.

Enrollment

263 estimated patients

Sex

All

Ages

22 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Age 22 to 80, inclusive of any gender
  2. Baseline pain intensity of >5 of the Numeric Rating Scale (NRS) despite current treatment Confidential Brixton Biosciences Inc. Page 12 of 53 Version: 1.1, 30 August 2024
  3. Chronic symptomatic osteoarthritis of the knee (K-L stage 2, 3, or 4) on plain x-rays obtained within the previous 12 months
  4. At least 3 months of previous conservative treatments (NSAID, acetaminophen, physical therapy, cortisone injections) that are not currently providing relief
  5. Agree to see one doctor (study investigator) for knee pain during the study period
  6. Willing/able to understand the informed consent form and provide written informed consent
  7. Able to complete outcome measures (including electronic patient reported outcome measures)

Exclusion criteria

  1. Known allergy to glycerol, hyaluronic acid, poloxamer 407, or phosphate buffered saline
  2. History of cryoglobulinemia
  3. History of cold-induced auto-immune hemolytic anemia (e.g. paroxysmal cold hemoglobinuria or cold agglutinin disease)
  4. History of cold urticaria
  5. History of Chilblain's (pernio) disease in the lower extremities
  6. History of Raynaud's disease
  7. Open and/or infected wounds or active tumor at or near the treatment site
  8. History of vascular surgery involving femoral vessels on the injection side
  9. History of surgical procedures to affected limb that, in the opinion of the investigator, could have impacted the integrity of the genicular nerves or blood vessels
  10. Active bacterial or fungal infection that at the discretion of the investigator would preclude study participation
  11. Currently taking >60 MME/day, as determined per MDcalc.com (opioid conversion calculator)
  12. History of History of systemic inflammatory conditions such as rheumatoid arthritis
  13. Bleeding disorders anticoagulant therapy, unless appropriately stopped or reversed for the procedure
  14. Any condition or circumstance that would impact or confound assessment of safety and/or pain. For example, comorbid or concomitant pain conditions, pre-existing lower limb neurologic deficits, any psychiatric or neurologic disease
  15. Cryoneurolysis, thermal or pulsed radiofrequency ablation, or phenol injection for the index knee within the past 12 months
  16. Use of intra-articular injection of corticosteroid within the previous 3 months, or hyaluronic acid, prolotherapy, Confidential Brixton Biosciences Inc. Page 13 of 53 Version: 1.1, 30 August 2024 autologous blood, or platelet rich plasma injections for the index knee within the previous 6 months
  17. Known contraindication to use of a regional anesthetic block
  18. Pregnant, nursing or intent of becoming pregnant during the study period
  19. Any condition (such as history of significant cardiovascular, renal failure/dialysis, hepatic or other systemic comorbidity/chronic pain condition) or circumstance that, in the opinion of the investigator, would compromise the safety of the subject or the quality of study data
  20. Body habitus/knee anatomy that would preclude the use of the product injection needle size
  21. Participation in any clinical study of a therapeutic investigational product within 30 days prior to enrollment
  22. Unwilling to refrain from participation in any other clinical study through the duration of this study
  23. Unwilling to refrain from any scheduled surgeries during the duration of this study

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

263 participants in 2 patient groups

Neural Ice injections
Experimental group
Description:
This therapy will be injected around the superolateral, superomedial, and inferomedial genicular nerves.
Treatment:
Device: Neural Ice
Corticosteroid injection
Active Comparator group
Description:
Intraarticular corticosteroid injection is defined as a single dose of Triamcinolone 40mg injected directly into the joint space.
Treatment:
Drug: Triamcinolone acetate

Trial contacts and locations

10

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Central trial contact

David Curd

Data sourced from clinicaltrials.gov

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