Two Single Arm, Multicentre Unblinded First-in-human Trials Investigating a Novel Ureteric Stent to Determine the Reduction of Encrustation, Biofilm Deposition and Complications Compared to a Conventional JJ Stent

Urological stents and catheters often lead to inflammation, causing pain and infection in the urinary tract. Moreover, 80% of stents are associated with pain, negatively impacting on QoL and mental health. Offering novel designs with significantly lower E&B leads to a reduction in UTIs and improves QoL. Reducing hospital admissions (from 3 to 1 per patient, annually) would free >100,000 bed-nights, allowing the elderly to regain independence. Our proposed research could have a significant impact towards fulfilling the 'healthy-ageing' Grand Challenge. Additionally, the novel stent reduces prevalence of infections and therefore, of antibiotic prescriptions contributing to the Global AMR challenge.

开始日期2025-02-28

申办/合作机构

The University of Southampton

[+1]

NCT05168943

/ RecruitingN/AIIT

Nylon Versus Polyurethane Epidural Catheters In Patients Undergoing Major Orthopedic Surgery

Objectives: To compare the safety and efficacy of nylon (polyamide) epidural catheter versus polyurethane epidural catheter in patients undergoing major orthopedic surgery under continuous epidural anesthesia.
Background: Continuous epidural anesthesia is the most common anesthetic technique used in orthopedic surgery. However, the use of epidural catheters is associated with complications. The insertion of the catheter may be associated with intravascular or intrathecal placement, nerve root irritation, paresthesia, kinking, hematoma, or breakage during catheter removal.
Patients and Methods: This was a prospective, randomized, double-blind clinical trial; carried out on 60 patients undergoing major orthopedic surgery under continuous epidural anesthesia. Patients were randomly allocated into two equal groups; group N, using Nylon catheter, and group P, using Polyurethane catheter.

开始日期2024-07-01

申办/合作机构-

ChiCTR2500098575

/ RecruitingN/AIIT

Clinical study on predicting the risk of venous access obstruction based on dynamic pressure monitoring system of intelligent injection pump

开始日期2024-01-12

申办/合作机构-

100 项与导管堵塞相关的临床结果

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100 项与导管堵塞相关的转化医学

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0 项与导管堵塞相关的专利（医药）

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项与导管堵塞相关的文献（医药）

2025-12-01·Child's Nervous System

Mechanisms of hydrocephalus after intraventricular haemorrhage: a review

Review

作者: Wu, Wenchao ; Li, Qingsong

Intraventricular haemorrhage (IVH) is bleeding within the ventricular system, which in adults is usually mainly secondary to cerebral haemorrhage and subarachnoid haemorrhage. Hydrocephalus is one of the most common complications of intraventricular haemorrhage, which is characterised by an increase in intracranial pressure due to an increased accumulation of cerebrospinal fluid within the ventricular system, and is closely related to the patient's prognosis. Surgical methods such as shunt surgery have been used to treat secondary hydrocephalus in recent years and have been effective in improving the survival and prognosis of patients with hydrocephalus. However, complications such as shunt blockage and intracranial infection are often faced after surgery. Moreover, little is known about the mechanism of hydrocephalus secondary to intraventricular haemorrhage. This review discusses the mechanisms regarding the occurrence of secondary hydrocephalus after intraventricular haemorrhage in adults in terms of blood clot obstruction, altered cerebrospinal fluid dynamics, inflammation, and blood composition.

2025-03-01·Supportive Care in Cancer

Symptomatic malignant ascites drainage with a patient-controlled vascular catheter: interim analysis of safety and patient-reported outcomes

Article

作者: Stukan, Maciej ; Ndukwe, Munachiso Iheme ; Cokan, Andrej ; Jędryka, Marcin ; Romanová, Martina ; Poblocka, Renata ; Timošek, Eva ; Kryszpin, Marcin ; Balcarová, Klára ; Madry, Radoslaw ; Klát, Jaroslav ; Cibula, David

Malignant ascites (MA) and repeated paracentesis can impair a patient's quality of life (QOL). The aim was to perform an interim analysis of safety and changes in patients' QOL in an ongoing prospective, multicentre (conducted within the Central and Eastern European Gynaecologic Oncology Group (CEEGOG)) trial on symptomatic MA drainage with a patient-controlled central vascular catheter (CVC) inserted into the abdominal cavity. CVC (14-Ga) was inserted into the abdominal cavity of patients with symptomatic MA, and drainage was controlled by patients at home. The rate and quality of complications were classified according to Common Terminology Criteria for Adverse Events Version 5.0. QOL was evaluated before and 10-14 days after/during drainage with standardized QLQ-C15-PAL, SGA, and FACIT-TS-G questionnaires. Wilcoxon and Chi-squared tests were used. Among 113 recruited patients (2015-2022), seven patients experienced complications (6.2%), and there was one patient with a serious adverse event (death on the 9th day after catheter insertion, classified as not related to the intervention). Adverse events included local infection (n = 2) (resolved after oral antibiotics), catheter obstruction (n = 2), catheter self-removal (n = 2) (re-insertion performed), and nausea (n = 1). When comparing the assessment before and after/during drainage, we found the significantly better global QOL (mean 31.8 vs. 47.8, p < 0.001), improvement in physical (52.6 vs. 64.4, p < 0.001) and emotional functioning (50.7 vs. 65.4, p < 0.001); symptoms were significantly less intense: fatigue (66.7 vs. 50.9, p < 0.001), nausea and vomiting (37.8 vs. 21.4, p < 0.001), pain (53.9 vs. 34.1, p < 0.001), dyspnoea (48.5 vs. 22.3, p < 0.001), insomnia (49.1 vs. 34.3, p < 0.001), appetite loss (56.3 vs. 40.3, p < 0.001), and constipation (31.0 vs. 25.2, p = 0.007), and more patients had no pain on eating (71.3% vs. 82.9%, p = 0.04). Most patients (78%) were satisfied, 83% would recommend the procedure to others, and 90% would choose intervention again. The interim analysis provided data on the safety and improvement of patients' QOL after MA drainage via patient-controlled CVC inserted into the abdominal cavity, thus justifying the continuation of recruitment for the main trial without changes in the protocol.

2025-03-01·Computers in Biology and Medicine

The effects of ventricle geometries and boundary conditions on computational modeling of ventriculoperitoneal catheters

Article

作者: Good, Bryan C ; TerMaath, Stephanie C ; Killeffer, James A

Hydrocephalus is a condition where an excess amount of cerebrospinal fluid (CSF) accumulates within the ventricles of the brain, leading to elevated intracranial pressure. The most common treatment is the surgical placement of a brain shunt to drain CSF from the ventricles. However, brain shunts have extremely high failure rates and improved devices are needed to minimize device obstruction and failure. To help establish modeling standards for this complex scenario, this work computationally investigates geometric and fluid dynamic variables to determine their effects on shunt performance, in addition to evaluating physiological modeling requirements. Catheter performance metrics included total catheter flow, drainage hole flows, and wall shear stresses (WSSs), which are all known to influence catheter obstruction. It was determined that ventricle and choroid plexus parameters (size, shape, and location) did not play a significant role in catheter performance (<2 % drainage hole flow differences, <12 % WSS differences). Further, patient-specific ventricle models were found to not affect catheter performance compared to a simplified cylinder model (<1 % drainage hole flow differences, <10 % WSS differences). Intracranial pressure boundary conditions, both static and pulsatile, were also applied. It was found that drainage hole flows and WSSs averaged over time were not significantly different between the waveforms and from comparable static pressure simulations. These results show that simplified geometric models and pressure boundary conditions can be used to computationally study ventriculoperitoneal (VP) catheter performance. The results of this research will enhance overall knowledge of CSF dynamics, provide modeling guidance, and contribute to the development of improved CSF shunts.

项与导管堵塞相关的新闻（医药）

2024-12-20

·美通社

碧迪医疗在华第三座世界级生产基地正式启幕，引领本土创新链升级

宜兴 2024年12月20日 /美通社/ -- 碧迪医疗科技（江苏）有限公司（简称"宜兴工厂"） 12月18日盛大开业，标志着碧迪医疗在中国的第三座世界级本土生产基地正式投入运营。宜兴市人民政府副市长、环科园党工委书记、管委会主任刘英、碧迪医疗全球药物输注解决方案业务总裁Eric Borin、泛亚洲区整合供应链副总裁莫霖耀及大中华区药物输注解决方案业务副总裁朱学良等多位政企领导出席了开业庆典，共同见证了这一历史性时刻。合影嘉宾：宜兴市人大主任许伟英、宜兴市人民政府副市长刘英、江苏省药品监督管理局无锡检查分局局长俞四维、中华护理学会高等护理教育专业委员会主任委员姜小鹰、碧迪医疗全球药物输注解决方案业务总裁Eric Borin、碧迪医疗泛亚洲区整合供应链副总裁莫霖耀、碧迪医疗全球药物输注与血管护理业务副总裁兼总经理Michelle Cunningham、碧迪医疗大中华区药物输注解决方案业务副总裁朱学良、碧迪医疗泛亚太区高级运营总监李源坤、碧迪医疗工厂厂长朱建良、碧迪医疗大中华区血管通路业务项目总监张芳宜兴工厂作为碧迪医疗布局长三角地区的关键一环，不仅承载着企业深度布局未来医疗市场的战略愿景，更是其本土化战略深化实践的重要里程碑。该工厂依托长三角地区成熟的产业链与高效的区块链路，旨在实现原材料供应、生产制造到市场投放的全链条本土化，以期精准满足中国医疗健康市场日益增长且日益多样化的需求。作为碧迪医疗在中国设立的第三座世界级生产基地及福徕喜 ® 本土化生产的核心基地，宜兴工厂近期取得了显著进展。上个月，宜兴工厂的福徕喜 ® 产线顺利启用并迅速达成了首批一百万支的销售佳绩。而在上周，宜兴人民医院也正式采用了宜兴工厂首批生产的宜兴福徕喜 ® 产品，为患者提供更安全、高效的护理服务。这些成就不仅标志着碧迪医疗在医疗护理领域本土化战略上的又一突破，也体现了其对中国市场及合作伙伴的坚定承诺。在开业庆典上，碧迪医疗全球药物输注解决方案业务总裁 Eric Borin 发表致辞："宜兴工厂的正式开业，标志着我们在全球药物输注解决方案业务战略上迈出了重要一步，同时也是碧迪医疗在中国本土化发展历程中的又一重要里程碑。多年来，碧迪医疗始终看好中国市场，不断将研发、生产与创新等关键发展环节置于中国，推动全球前沿医疗科技在中国落地生根。同时，我们积极联动‘政产学研医'各方力量，共同推进本土医疗创新生态圈的建设。这再次证明了我们对中国市场及本土合作伙伴的坚定承诺。展望未来，碧迪医疗将继续引入更多先进的医疗输注技术和产品，不断深化在药物输注领域的本土化布局，与中国医疗健康事业携手并进，共同推动其高质量发展。" 对此，宜兴市人民政府副市长、环科园党工委书记、管委会主任刘英在致辞中表示："在全力打造医疗产业高地的征程中，宜兴通过一系列的红利政策，为企业提供了强有力的支持与帮助，促进了企业在本地市场的有序、稳健发展。此次碧迪医疗生产基地在宜兴的正式落成与开业，不仅标志着双方在医疗科技领域的深度合作迈出了坚实的一步，更寄托了我们深切的期望，期待未来能充分发挥宜兴的地理位置优越、产业基础雄厚、人才资源丰富、科研实力雄厚等优势，带动更多创新产品走向全国。" 中国作为全球第二大医疗器械市场，对高品质、高性能的医疗器械和解决方案的需求持续扩大。在此背景下，中国已经构建起了从原材料供应、零部件制造到整机组装的完整医疗器械产业链，为碧迪医疗在内的跨国公司提供了产业链协同和资源共享的机遇。碧迪医疗宜兴工厂总投资额高达13.32亿元人民币，占地面积54亩，总建筑面积为35000平方米。全面建成后，预计年产能将达到瓶装注射剂250万升，预填充盐水注射器4亿支。这座规模宏大的工厂不仅彰显了碧迪医疗对中国市场的深切信心，也展示了其在本土化生产和供应链优化方面的卓越实力。通过在中国设立本土生产基地，碧迪医疗能够进一步融入中国医疗工业链和供应链体系的创新发展，深入了解本土医护工作者和患者的需求和偏好，以开发出更符合中国市场需求的产品。同时，借助高效、智能的生产模式，碧迪医疗能够有效缩短产品交付周期，提高市场响应速度，从而提升市场竞争力。此外，碧迪医疗在中国设立生产基地，还能带来技术溢出效应，赋能本土医疗器械产业的技术水平和管理能力，促进技术创新和产业升级，为中国本土医疗器械企业的出海发展提供助力。碧迪医疗泛亚洲区整合供应链副总裁 Michael Mok 对此表示，"进入中国三十年，碧迪医疗的本土化发展迎来了一个又一个重要里程碑。从1995年碧迪苏州一厂落址，到2008年碧迪苏州二厂奠基，再到今天宜兴工厂的启幕，每一步都彰显着我们持续深耕中国市场的决心与信心。宜兴工厂配备了全球领先的全自动生产线，将专注于预充式导管冲洗器的本土化生产。中国作为碧迪全球第二大市场，我们将在未来继续探索更多投资机会，携手多方本土伙伴，实现更多产品来自中国本土制造，以继续践行我们在中国的长期承诺。" 碧迪医疗大中华区药物输注解决方案业务副总裁朱学良也指出："创新始终是碧迪医疗药物输注业务的核心发展动力。碧迪不断引入全球最先进的医疗技术和设计理念，研发出一系列符合中国患者和医疗机构需求的产品。其中，福徕喜 ® 预充式导管冲洗器已经在中国上市十五年，凭借其方便快捷及独家抗血液回流专利，可以有效降低院内感染及导管堵塞风险，在临床工作中广受好评，成为众多医疗机构的首选。作为福徕喜 ® 本土化生产的重要基地，宜兴工厂集顶尖制造设施与先进生产工艺于一体，确保了福徕喜 ® 产品的卓越品质和可靠性能。同时，工厂将以更加贴近本土需求、高效响应市场的方式，满足国内广大输液患者的迫切需求，为提升中国医疗体系的整体效能和民众的健康福祉作出积极贡献。" 政企领导参观碧迪医疗宜兴工厂碧迪医疗宜兴工厂的落地，为园区注入了一股强劲的新动力，不仅丰富了园区的产业生态，更是促进了长三角地区医疗产业供应链的效能提升，带来了广泛而积极的影响。同时，碧迪医疗宜兴工厂的落地，也进一步促进了产业集聚效应的形成。随着该工厂的投产，更多的上下游企业有望被吸引至此，形成更为紧密的产业链合作，从而推动宜兴乃至整个长三角地区的医疗健康产业实现更快更好的发展。此外，该工厂还带来了大量的就业机会，为当地民众提供了更多的就业岗位和职业发展机会，进一步促进了区域经济的繁荣和稳定。自1994年进入中国以来，碧迪医疗秉持着"根植中国，服务中国"的本土化发展理念，持续加码在华投资与本土化布局，目前共交付10万创新产品，并致力于积极构建医疗科技行业创新协作生态。除了积极引进全球领先的创新产品，持续满足中国医疗系统和患者的多样化需求，碧迪医疗已在中国构建起一个涵盖3座本土制造工厂、2个研发中心、6个培训中心、1个客户服务中心、1个客户体验中心以及1个创新中心于一体的强大基础设施网络。这一网络不仅展现了碧迪医疗对中国市场的长期承诺，也体现了其在提升本土医疗服务水平和推动健康产业发展方面的积极作用。碧迪医疗通过实施本土化生产战略，成功将高精尖技术与中国患者需求紧密结合。随着宜兴工厂的盛大开业及逐步投产，碧迪医疗将进一步深化本土创新布局，以更加高效的方式推动中国医疗健康产业迈向高质量发展新阶段，为民众健康福祉提供更为坚实的保障，有力支持"健康中国2030"目标的实现。未来，碧迪医疗将继续秉承"创新引领、品质卓越、服务至上"的核心价值观，致力于将更多前沿技术和创新产品引入中国，满足国内广大患者的迫切需求。碧迪医疗正以切实行动，逐步将中国智慧与解决方案融入全球医疗科技产业的进步与发展中。关于碧迪医疗 About BD 碧迪医疗是一家全球化的医疗技术公司，通过改善医学发现方法、医疗诊断效果和护理质量以引领世界健康。碧迪医疗关注并支持每位一线医务工作者，致力于通过研发创新技术、服务和解决方案，帮助患者改善临床治疗，并帮助医护人员改进临床流程。碧迪医疗及其75,000名全球员工秉承高度的热情和信念，为临床医护人员提供安全、高效的护理给药流程，协助实验室科学家们更有效地诊断疾病，并提升科研人员研发新一代诊断及治疗疾病的能力。碧迪医疗在几乎所有国家均设有分支机构，与全球范围内的组织机构积极合作，携手应对最具挑战的全球健康问题。通过与客户的紧密协作，碧迪医疗以改善治疗结果，降低医疗成本，提升诊断效率为己任，帮助加强患者和医护人员的安全并扩大医疗可及性。

高管变更引进/卖出

2024-05-22

·BioSpace

NanoVibronix Announces Commencement of UroShield Clinical Study at the University of Michigan

ELMSFORD, N.Y.--(BUSINESS WIRE)-- NanoVibronix, Inc. (Nasdaq: NAOV), a medical device company that produces the UroShield®, PainShield® and WoundShield® Surface Acoustic Wave (SAW) Portable Ultrasonic Therapeutic Devices, today announced that the University of Michigan will begin the pilot phase of its clinical trial of UroShield this week. The “pilot” phase of the study is the first component of the broader study. As previously announced on November 28, 2023, the company signed a Research Agreement with the Regents of the University of Michigan for a Randomized Control Trial (“RCT”) study of UroShield to further advance clinical evidence of the efficacy of UroShield. This link will take you to the company’s previous press release. Brian Murphy, Chief Executive Officer of NanoVibronix, Inc., said, “Entering into the pilot phase of the UroShield study at the University of Michigan is an important step towards our goal of applying for permanent FDA clearance or approval for the UroShield product. The experienced and highly accomplished team of researchers at Michigan is studying the impact UroShield may have on reducing urinary tract infections, catheter blockage pain and improving the quality of life of the patients studied. The pilot portion of the study will include up to 30 patients, while the full study is expected to encompass an estimated 300 patients, primarily nursing home residents.” About NanoVibronix NanoVibronix, Inc. (Nasdaq: NAOV) is a medical device company headquartered in Elmsford, New York, with research and development in Nesher, Israel, focused on developing medical devices utilizing its patented low intensity surface acoustic wave (SAW) technology. The proprietary technology allows for the creation of low-frequency ultrasound waves that can be utilized for a variety of medical applications, including for disruption of biofilms and bacterial colonization, as well as for pain relief. The devices can be administered at home without the assistance of medical professionals. The Company’s PainShield® product is a portable device suitable for administration at home without assistance of medical professionals. Additional information about NanoVibronix is available at: . Forward-looking Statements This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with: (i) market acceptance of our existing and new products or lengthy product delays in key markets; (ii) negative or unreliable clinical trial results; (iii) inability to secure regulatory approvals for the sale of our products; (iv) intense competition in the medical device industry from much larger, multinational companies; (v) product liability claims; (vi) product malfunctions; (vii) our limited manufacturing capabilities and reliance on subcontractor assistance; (viii) insufficient or inadequate reimbursements by governmental and/or other third party payers for our products; (ix) our ability to successfully obtain and maintain intellectual property protection covering our products; (x) legislative or regulatory reform impacting the healthcare system in the U.S. or in foreign jurisdictions; (xi) our reliance on single suppliers for certain product components, (xii) the need to raise additional capital to meet our future business requirements and obligations, given the fact that such capital may not be available, or may be costly, dilutive or difficult to obtain; (xiii) our conducting business in foreign jurisdictions exposing us to additional challenges, such as foreign currency exchange rate fluctuations, logistical and communications challenges, the burden and cost of compliance with foreign laws, and political and/or economic instabilities in specific jurisdictions; and (xiv) market and other conditions. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at: . The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events, or otherwise, except as required by law.

临床研究