ACTRN12619001252101已完成未知
Single-Arm, Multicenter Study to Evaluate Safety and Efficacy of Low Frequency Spinal Cord Stimulator in Subjects with Low Back and/or Leg Pain
Presidio Medical AU, Pty Ltd0 个研究点目标入组 20 人开始时间: 2019年9月11日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •literate, able to speak English and able to complete questionnaires independently.
- •- Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol.
- •- have been diagnosed with chronic, intractable pain of the low back and/or legs (VAS greater than or equal to 60mm for the past week) which has been refractory to conservative therapy for a minimum of 3 months.
- •- Are currently receiving optimal medical management and considered medically stable as judged by the investigator.
- •- Able to change AA batteries and operate the EPG.
排除标准
- •1 If female and sexually active, subject must be using a reliable form of birth
- •control, be surgically sterile or be at least two years post-menopausal
- •2. IV Contrast allergy
- •3. Severe cognitive impairment as determined by investigator
- •4. A psychological assessment will be performed at Baseline to exclude an
- •active disruptive psychological or psychiatric disorder or other known
- •condition significant enough to impact perception of pain, compliance of
- •intervention and/or ability to evaluate treatment outcome. This will be
- •performed by the investigator in consultation with a clinical psychologist if
- •5. Pre-existing motor, balance, proprioception, or sensory deficits as determined
- •by investigator
- •6. Spinal Stenosis or other structural spinal abnormality observed on MRI that
- •would make lead placement unsafe or untowardly difficult as determined by
- •investigator
- •7. Currently taking anticoagulants including Warfarin, Heparin, Low Molecular
- •Weight Heparin, Factor Xa inhibitors, GPIIb/IIIa inhibitors, thienopyridine
- •inhibitors, direct thrombin inhibitors, or any other anticoagulant that is a
- •contraindication to epidural lead placement within 1 week of the Screening
- •8. Current coagulopathy, thrombocytopenia or bleeding diathesis (confirmed by
- •clinical history and, if clinically indicated, by coagulation screening)
- •9. Cardiac demand pacemaker, implanted defibrillator or other implanted
- •electronic device
- •10. A systemic condition or disease not stabilized or judged by the investigator to
- •be incompatible with participation in the study (e.g. current systemic infection,
- •uncontrolled autoimmune disease, uncontrolled immunodeficiency disease,
- •history of myocardial infarction, etc.)
- •11. Known hypersensitivity to any of the procedural agents or materials in the
- •study device that is inserted into the subject
- •12. Previous non-responder to spinal cord stimulation
研究者
相似试验
招募中
不适用
Single-Arm, Multicenter, Study to Evaluate Safety and Efficacy of an Ultra-Low Frequency Spinal Cord Stimulator in Subjects with Painful Diabetic NeuropathyPainful Diabetic NeuropathyMetabolic and Endocrine - DiabetesACTRN12621000741886Presidio Medical AU Pty Ltd10
进行中（未招募）
1 期
CS12 adolescent studyEUCTR2011-002065-37-NOBayer HealthCare AG304
进行中（未招募）
不适用
CS12 adolescent studyContraceptionMedDRA version: 14.1Level: PTClassification code 10010808Term: ContraceptionSystem Organ Class: 10042613 - Surgical and medical proceduresEUCTR2011-002065-37-ATBayer HealthCare AG360
已完成
3 期
Multi-center, single-arm study to assess the safety, efficacy, discontinuation rate and pharmacokinetics of the low-dose levonorgestrel intrauterine contraceptive system (LCS12) in post-menarcheal female adolescents under 18 years of age for 1 year, and an optional 2-year extension phaseintrauterine anticonceptieintrauterine system as a contraceptiveprevention of pregnancyNL-OMON40073Bayer96
进行中（未招募）
不适用
CS12 adolescent studyContraceptionMedDRA version: 14.0Level: PTClassification code 10010808Term: ContraceptionSystem Organ Class: 10042613 - Surgical and medical proceduresEUCTR2011-002065-37-NLBayer HealthCare AG360