DRKS00017502进行中（未招募）1 期
First-in-Human Study to evaluate Safety, Feasibility and preliminary Efficacy of the new ISS Sleeve Augmentation Technique in the Treatment of osteoporotic/osteopenic vertebral Fractures in the thoracolumbar Spine. - ISSCLIN-02
exilis AG0 个研究点目标入组 2 人开始时间: 2019年6月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2
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
- 50 Years 至 85 Years（—）
- 性别
- All
入选标准
- •1. Age = 50 and = 85, male and female patients
- •2. Subject is able to understand the risks and benefits of participating in the study and is willing to provide written informed consent.
- •3. Psychosocially, mentally and physically able to fully comply with the protocol requirements for the duration of the study including adhering to scheduled visits, treatment plan, completing forms and other study procedures.
- •4. Single vertebra fracture located between the 10th thoracic and 4th lumbar vertebra, both included, caused by a diagnosed or by a primary or secondary osteopenia / osteoporosis
- •5. Bone mineral density equal or above the threshold of 60 mgHA/ccm (central assessment of the screening qCT scan).
- •6. Single vertebra body fractures with the indication and possibility for augmented bi-segmental dorsal pedicle screw and rod stabilization including two short index-screws in the broken vertebra
- •7. All fractures where pedicle screws of the following type (that have been proven for appropriate functionality with the ISS) can be used:
- •o DePuy Synthes, Expedium Viper2 CFX Polyschraube (diameter 6.0 mm)
- •o Silony Medical, VERTICALE VPS-6255-KF1 (diameter 6.2 mm),
- •o Medtronic, Horizon SOLERA MAS CC (diameter 6.5 mm),
- •o ulrich medical, uCentrum (diameter 5.5-6.5 mm),
- •o Medtronic, CD Horizon Legacy (Longitude) (diameter 6.5 mm)
- •At the discretion of the investigator pedicle screws with lengths between 35 and 60 mm can be used.
排除标准
- •1. Substance use disorders (incl. tobacco abuse >20 cigarettes/day) and alcohol abuse disorders within the last 5 years before enrolment into the trial.
- •2. BMI > 35
- •3. Permanent or progressive neurologic deficits (incl. upper Motor neuron disease and myelopathy)
- •4. Known Creutzfeldt Jacob Disease
- •5. Systemic infections:
- •- Known infection with human immunodeficiency virus (HIV) or hepatitis B or C requiring treatment
- •- Any active infection requiring the use of parenteral anti-microbial agents or that is > grade 2 Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03
- •6. Rheumatoid arthritis or known disorders of bone metabolism (excl. osteopenia/osteoporosis, Vitamin D deficiency)
- •7. Radiation therapy of the spine in medical history
- •8. Contraindications to pedicle screw and rod stabilization
- •9. Breast feeding, pregnancy or child-bearing potential (female patients of childbearing potential and male patients with a partner of child bearing potential must agree to use a highly effective contraceptive method).
- •10. A compromised immune system or a therapy with systemic corticosteroids or immunosuppressants
- •11. Active malignancy or history of malignancy (excl. Basalioma as a semi-malignant tumor) < 5 years ago from time of enrolment into the trial
- •12. Known allergy to any component of the investigational device
- •13. History of severe allergy, anaphylactic reactions and hypersensitivity reactions experienced in previous surgical interventions
- •14. Other concurrent severe and/or uncontrolled medical conditions (e.g. insufficiently treated diabetes (HbA1c > 8 %), active or uncontrolled
- •infection) that could cause unacceptable safety risks or compromise compliance with the protocol
- •15. Participation in other clinical investigations for drugs or devices
- •16. Fracture age > 3 months
- •17. Major surgery to the spine planned for at least 12 months following enrolment
- •18. Any treatment of the fracture other than that specified in the inclusion criteria (e.g. kyphoplasty, vertebroplasty, additional ventral
- •stabilization)
- •19. Severe spinal deformations or fusion at the target vertebral or adjacent segments
- •20. Previous operations at the spine in the target or adjacent vertebrae
- •21. Infections or inflammatory processes at vertebral bodies
研究者
相似试验
已完成
1 期
A first-in-human study to evaluate the safety, tolerability and performance of uncoated and placebo-coated NanopatchesVaccination Delivery DeviceOther - Research that is not of generic health relevance and not applicable to specific health categories listed aboveACTRN12615000583549Vaxxas Pty Ltd18
尚未招募
Unknown
Embolisation with NeoCast for Chronic Subdural HematomaeurologicalNeurologicalNeurological - Other neurological disordersACTRN12624000659505Arsenal Medical Australia Pty Ltd.10
进行中（未招募）
1 期
Study to evaluate QR-421a in subjects with retinitis pigmentosa (RP) due to mutations in exon 13 of the USH2A GeneEUCTR2018-002433-38-FRProQR Therapeutics18
招募中
不适用
A First in Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of IBC-Ab002 in Persons with Early Alzheimer's DiseasedementiaNL-OMON56092ImmunoBrain Checkpoint, Inc6
进行中（未招募）
1 期
First in human study to test the safety and preliminary efficacy of PPSGG, an antibody catcher in patients with anti-MAG neuropathyEUCTR2020-000067-23-FRPolyneuron Pharmaceuticals AG48