Source Healthcare is proud to announce its involvement in a pivotal Phase III clinical trial for Pacira’s‘s investigational therapy, iovera°. This innovative treatment aims to provide lasting relief for patients with any confirmed cerebral or spinal condition resulting in spasticity of the muscles controlling the shoulder and elbow.
Pacira - A Phase III Clinical Trial Using Cryotherapy for Upper Limb Spasticity
Overview of the Iovera° Clinical Trial
The iovera° Phase III clinical trial is an innovative study that aims to evaluate the safety and efficacy of the ultrasound-guided iovera° system that apply cryoneurolysis to the affected nerves in the upper extremities that result in muscle spasticity. The iovera° system temporarily freezes the targeted nerve, immediately blocking the nerve from sending pain signals to the brain. First, a cold zone is created by lowering the temperature to below -20ºC. This cold zone causes degeneration of the axon and myelin sheaths of the neuron, which is what causes temporary blockage of nerve signals. After treatment, the axon begins to regenerate at a rate of 1-2mm per day. Once the axon and myelin sheath are fully regenerated, nerve signaling is restored.
Participants in the trial will undergo a structured program, including an initial screening phase, a single treatment visit, and follow-up visits over 13 weeks. The study is a step in offering a minimally invasive alternative for patients who have not found relief through conventional therapies, providing hope for long-term spasticity management and improved quality of life.
Study Design and Visit Requirements
The Pacira – Phase III clinical trial is a structured program that aims to assess the efficacy and safety of iovera°. Participants will engage in the study for 13 weeks, with a minimum of 5 visits to the research site. These visits are divided into three distinct phases: screening, treatment, and follow-up. Here’s what you can expect during each phase.
Screening Phase
Before beginning the trial, you will undergo a thorough screening to determine your eligibility. This includes a medical history review, diagnostic tests, and discussions with our clinical team about your health and pain history. The goal is to confirm that you meet all the criteria for participation, ensuring the trial is suitable for your condition and will deliver meaningful results.
Treatment Phase
Once enrolled, you will receive treatment using the ultrasound-guided iovera° system (the investigational treatment) or a placebo (sham treatment) as part of the study’s control group. This single outpatient procedure is minimally invasive and administered to the targeted nerves. The treatment targets nerves to increase quality of life and decrease spasticity
Follow-Up Phase
After the injection, you will participate in regular follow-up visits over 13 weeks. These visits allow our team to monitor your progress, assess your response to the treatment, and ensure your overall health. You’ll undergo physical exams, pain assessments, and functional evaluations. This phase is critical for understanding the long-term benefits of the treatment.
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Potential Benefits of Participation:
- Access to a state-of-the-art therapy that could alleviate muscle spasticity.
- All treatments, assessments, and diagnostics are covered at no cost to you or your insurance.
- Participants will receive compensation for their time and travel associated with the study.
Cost and Compensation for Participation
Participating in the iovera° clinical trial comes at no cost to you. All treatments, diagnostic procedures, and assessments required for the study are fully covered by the trial sponsor. Additionally, you will receive compensation for your time and travel to each of the follow up visits over the 13-week study period. This ensures you can focus on your health and participation without financial burden.
You May Be Eligible to Participate in the Study if:
- You are aged 18 years or older
- You have a confirmed diagnosis of any cerebral or spinal condition, at least 6 months before Screening
- You experience spasticity of the muscles controlling the shoulder and elbow.
- You are able to provide informed consent, adhere to the study schedule, and complete all study assessments.
- You are not currently pregnant, nursing, or planning to become pregnant during the study.
How to Enroll in the Pacira - A Phase III Clinical Trial
If you are interested in participating or would like more information about the Mesoblast Phase III Clinical Trial, we invite you to contact our research team.
Phone: Call 310-564-5820 ext. 3
