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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 5
- 试验地点
- 3
- 主要终点
- Pain Management
研究概览
简要总结
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.
详细描述
Hypothesis:
Cryoanalgesia (iovera°®) will provide a safe, effective and feasible tool as a pain medicine modality to offer analgesic pain relief in patients with Morton's Neuroma, thereby introducing a new non-opioid therapeutic option to these patients in need.
Primary Objective:
To define and characterize the analgesic effect following a single cryoanalgesic application to the Dorsal, Digital Proper Nerve/s in subjects diagnosed with Morton's Neuroma, who have failed conservative therapies.
Primary Endpoints:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy adult male or female volunteers ages 18 or older.
- •Able to provide informed consent, adhere to the study schedule, and complete all study assessments.
- •Body Mass Index (BMI) ≥18 and ≤40 kg/m
- •Unilateral Morton's Neuroma diagnosed by MRI.
- •Subject has failed conservative treatment options.
排除标准
- •Documented allergy, hypersensitivity, intolerance, or contraindication to amide-type local anesthetics (i.e., lidocaine), or opioids, NSAIDs.
- •Documented history of uncontrolled diabetes, bleeding disorder, severe Peripheral Vascular Disease (PVD).
- •Concurrent painful physical condition that may require analgesic treatment (i.e., long-term opioid use) which, in the Principal Investigator's opinion, may confound the treatment assessments.
- •History of, suspected, or known addiction to/or abuse of illicit drug/s, prescription medicine/s, or alcohol within the past 3 years.
- •Administration of an investigational drug or medical device within 30 days of the Screening Period.
- •Previous participation in a cryoneurolysis study.
- •Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Principal Investigator, could potentially interfere with study assessments or compliance.
- •Currently pregnant, nursing, or planning to become pregnant during the study.
- •Clinically significant medical disease that, in the opinion of the Principal Investigator, would make participation in a clinical study inappropriate.
- •Inadequate sensory function of the affected foot (as defined at the Screening Visit Neurologic Lower Extremity (LE) exams).
- •Any clinically significant event or condition uncovered during the Screening Period (e.g., contra-lateral foot injury) that, in the opinion of the Principal Investigator, renders the subject medically unstable or complicates the subject's study participation.
- •Subject has a history of: Cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria or Raynaud's Disease.
- •Subject has an active, wound, open and/or potential infection near the anticipated treatment site.
结局指标
主要结局
Pain Management
时间窗: Six Months
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.
次要结局
- Adverse Events and Serious Adverse Events(Six Months)
- Ambulation(Six Months)
- Medical Device Feasibility(Six Months)