DRKS00013981已完成未知
An European multi-centre, open-label, prospective, feasibility study evaluating the Nalu Alpha External Trial Stimulator for the treatment of chronic pain via Spinal Cord Stimulation (SCS) - NAL-02-2016-FS
alu Medical, Inc.0 个研究点目标入组 25 人开始时间: 2018年4月5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
- 25
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
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Subjects have been diagnosed with chronic, intractable pain of the low back and/or leg(s) (VAS = 6 for one or both leg(s) and/or back), which has been refractory to conservative therapy, after surgical intervention for a minimum of 6 months (post-lumbar laminectomy syndrome, failed back surgery syndrome, FBSS). Conservative pre- and post-operative measures may have included, but not exclusive to, physical therapy, medication management, epidural injections, facet blocks and/or denervation without material long-term response. Failure of any intervention is defined as return of symptoms to pre-intervention levels after 6 weeks.
- •Have been approved by their doctor to undergo a commercial trial of SCS.
排除标准
- •1. Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator
- •2. Have 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 outcomes
- •3. Are not a surgical candidate due to a diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease, progressive neurologic disorder (e.g., polyneuropathy, MS) or uncontrolled diabetes mellitus
- •4. Have a condition, treatable with SCS, that requires leads to be inserted into the cervical region
- •5. Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker
- •6. Have a condition currently requiring or likely to require the use of MRI or diathermy
- •7. Have pain due to a malignant disease
- •8. Have a life expectancy of less than 1 year
- •9. Have an active systemic or local infection
- •10. Be pregnant or nursing
- •11. Have within 6 months of enrollment a significant untreated addiction to dependency producing medications or have been a substance abuser (including alcohol and/or illicit drugs)
- •12. Be concomitantly participating in another clinical study
- •13. Are under active workers’ compensation (or personal injury) litigation or adjudication.
研究者
相似试验
进行中（未招募）
不适用
An open-label, two-step, multicenter European study to evaluate the efficacy and safety of Sandostatin LAR at High Dose or in combination either with GH-receptor antagonist or dopamine-agonist in acromegalic patients not adequately controlled by conventional regimen - NDMedDRA version: 9.1Level: LLTClassification code 10000599Term: AcromegalyacromegalyEUCTR2005-005852-42-ITOVARTIS FARMA100
进行中（未招募）
1 期
An open-label, two-step, multicenter European study to evaluate the efficacy and safety of Sandostatin LAR at High Dose or in combination either with GH-receptor antagonist or dopamine-agonist in acromegalic patients not adequately controlled by conventional regimen - HOSCARMedDRA version: 9.1 Level: LLT Classification code 10000599 Term: AcromegalyAcromegalyEUCTR2005-005852-42-BEovartis Pharma Services AG
进行中（未招募）
不适用
An open-label, two-step, multicenter European study to evaluate the efficacy and safety of Sandostatin LAR at High Dose or in combination either with GH-receptor antagonist or dopamine-agonist in acromegalic patients not adequately controlled by conventional regimen - HOSCARMedDRA version: 9.1Level: LLTClassification code 10000599Term: AcromegalyAcromegalyEUCTR2005-005852-42-PTovartis Pharma Services AG100
已完成
4 期
A post marketing surveillance study evaluating effectiveness and tolerability of Trioptal® (Oxcarbazepine) in patients with generalized tonic-clonic seizures as monotherapy in routine clinical practice in IndiaCTRI/2012/12/003238ovartis India Ltd500
已完成
4 期
Study to evaluate the effectiveness and tolerability of Carbamazepine (TEgrital®) as Monotherapy in patients with generalized tonic-clonic seizures.CTRI/2013/10/004071ovartis India Limited493