ISRCTN11180496已完成未知
A multi-center prospective observational clinical study to evaluate HF10™ therapy in patients with chronic intractable leg pain
evro Corp0 个研究点目标入组 121 人开始时间: 2018年2月23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
- 121
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •1. Leg pain either idiopathic in origin or from failed back surgery syndrome which has been refractory to conservative therapy for a minimum of 3 months
- •2. Leg pain intensity of = 5 out of 10 cm on the Visual Analog Scale (VAS) at enrollment
- •3. Neuropathic pain as clinically determined by the investigator
- •4. On stable pain medications, as determined by the Investigator, for at least 4 weeks prior to the Baseline Visit
- •5. Be an appropriate candidate for HF10 therapy according to the current labeling of the device
- •6. At least 18 years of age at time of enrollment
- •7. Completed evaluation at the investigational site at least once prior to screening for the pain condition related to the study
- •8. Willing and able to comply with study-related requirements, procedures and visits
- •9. Capable of subjective evaluation, able to read and understand written questionnaires, and able to read, understand and sign the written informed consent
排除标准
- •1. A medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study assessments, accurate pain reporting, and/or confound evaluation of study endpoints
- •2. Evidence of 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, as determined by the investigator in consultation with a clinical psychologist if applicable
- •3. A current diagnosis of a progressive neurological disease such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, rapidly progressive diabetic peripheral neuropathy, brain or spinal cord tumor, or severe/critical spinal stenosis
- •4. A visceral pain in the area being treated
- •5. A current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease or uncontrolled diabetes mellitus
- •6. A diagnosis of scoliosis that precludes lead placement
- •7. Leg pain that occurs only with weight bearing
- •8. Benefitting within 30 days prior to enrollment from an interventional procedure and/or surgery to treat back and/or leg pain
- •9. Existing drug pump and/or SCS system or another active implantable device such as a pacemaker (switched On or Off)
- •10. Have a condition currently requiring or likely to require diathermy
- •11. Metastatic malignant disease or active local malignant disease
- •12. A life expectancy of less than 1 year
- •13. An active systemic or local infection
- •14. Pregnant (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile or be at least 2 years post-menopausal)
- •15. Within 6 months of enrollment a significant untreated addiction to dependency producing medications or have been a substance abuser (including alcohol and illicit drugs)
- •16. Concomitantly participating in another clinical study, or planned to be enrolled in another clinical study that could interfere in participation in this study or affect the scientific soundness of this study
- •17. Involved in an injury claim under current litigation
- •18. A pending or approved work cover claim
研究者
相似试验
已完成
不适用
A clinical study to evaluate HF10™ therapy in patients with chronic intractable predominant leg paiChronic, intractable predominant leg painSigns and SymptomsISRCTN11720855evro Corp90
已完成
不适用
An Observational, Prospective Multicentre Clinical Study to assess the safety and clinical performance of a New Single-use Negative Pressure Wound Therapy System (PICO 7Y) for the Simultaneous Management of Bilateral Closed Incisions in Oncoplastic Breast Surgery Patientsbreast cancer surgeryOncoplastic breast surgery10006295NL-OMON48115Smith&Nephew, Inc6
已完成
不适用
A prospective, observational, multicenter clinical investigation evaluating the clinical outcomes of tibial and/or ankle fractures stabilizedby the temporary external fixator Galaxy UNYCO SystemTibial and ankle fracture/s that do not allow immediate definitive treatment and having a regular indication for surgical intervention with a temporary external fixatorDRKS00011523Orthofix Srl28
已完成
不适用
AI based MicroscopyCTRI/2021/04/032726Sevamob Ventures Limited1,200
已完成
不适用
The prospective observational multi-center study about regional cerebral oxygen saturation for prediction of neurological outcomes in patients after out-of-hospital cardiac arrestOut-of-hospital cardiac arrestJPRN-UMIN000005065Osaka Saiseikai Senri Hospital1,000