An Open-Label, Non-Randomized Study Investigating the Coolio System (BXT-786 3.0 Device): A Novel Approach for Managing Knee Pain in Osteoarthritis through Cold Energy Regional Analgesic Block

Brixton Biosciences0 个研究点目标入组 6 人开始时间: 2024年3月14日最近更新: 2024年3月18日

适应症

试验速览

暂无简介。

•Baseline pain intensity of at least 5 on the Numeric Rating Scale (NRS), despite current treatment
•- A decrease of at least 50% from baseline Numeric Rating Scale (NRS) with diagnostic genicular nerve block
•- Chronic symptomatic osteoarthritis of the knee (K-L stage 2, 3, 4) on plain x-rays
•- Failed conservative treatments (NSAIDs, acetaminophen, physical therapy, and cortisone injections).

•- History of cryoglobulinemia
•- History of cold-induced auto-immune hemolytic anemia (e.g. paroxysmal cold hemoglobinuria or cold agglutinin disease)
•- History of cold urticaria
•- History of Chilblain’s (pernio) disease in the lower extremities
•- History of Raynaud’s disease
•- Currently taking >60 MME/day, as determined per opioid conversion calculator
•- Cryoneurolysis, thermal or pulsed radiofrequency ablation, or phenol injection for the index knee within the past 12 months
•- Use of intra-articular injection of corticosteroid, hyaluronic acid, prolotherapy, autologous blood, or platelet rich plasma injections for the index knee within the previous 3 months

发起方

Brixton Biosciences