NCT06942819Enrolling By Invitation不适用
Magnetic Resonance Imaging (MRI) Outcomes of VersaWrap Verve Protector Following Lumbar Decompression Surgery
Research Source1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2025年8月8日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- MRI
研究概览
简要总结
The purpose of this study is to evaluate enhancement patterns in magnetic resonance imaging (MRI) evidence following the use of VersaWrap in bilateral lumbar decompression surgeries.
详细描述
This study is a prospective, post-market, observational multi-center evaluation of the use of VersaWrap. Patients identified by the Investigator in their practice as needing a bilateral lumbar decompression at one level (L4-S1) and meeting all the inclusion and none of the exclusion criteria. Patients will consent to participating in the study, prior to any study procedures.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged ≥18 and ≤65 at time of surgery
- •Patients undergoing lumbar decompression bilaterally at one level from L4-S1
- •Psychologically, mentally and physically able to fully comply with this protocol including adhering to follow-up schedule, study requirements with a signed informed consent.
排除标准
- •Non-English speaking
- •Known allergy or sensitivity to citrate, alginate or hyaluronate
- •Known allergy or sensitivity to MRI contrast dye
- •Known to experience claustrophobia
- •Pregnant or breastfeeding at time of surgery
- •Incarcerated at time of surgery
- •Prior lumbar surgery at the index level
- •Conjunction device use at index level (i.e., Barricade)*
- •Patient has any condition, that in the opinion of the Investigator, would prohibit the patient from complying with the protocol *Note: conjunction medications (i.e., Depo-Medrol, Marcaine/Epinephrine) are acceptable
结局指标
主要结局
MRI
时间窗: 4 months
Magnetic resonance imaging (MRI) will be used to evaluate enhancement patterns
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Magnetic Resonance Imaging to Study the Normal EyeLens DiseaseCataractNCT00005911National Eye Institute (NEI)20
Unknown
不适用
DTI in Evaluation of Parkinsons DiseaseMri in ParkinsonsNCT05231356Assiut University50
招募中
不适用
Incremental Value of Magnetic Resonance Imaging in Selection of Pancreatic Cancer Patients for SurgeryLiver MetastasesPancreatic CancerPancreatic NeoplasmNCT05428358University of Aarhus200
已完成
不适用
Magnetic Resonance Spectroscopic Imaging of the Prostate at 3 TeslaMRIProstate CancerNCT00588679Memorial Sloan Kettering Cancer Center265
已完成
2 期
Using Magnetic Resonance (MR) to Understand the Effect of Erythromycin on Bowel MotilityHealthyNCT01379183Mayo Clinic40