ACTRN12615001008516已完成1 期
A prospective, Phase 1, open treatment, non comparative, single centre, device study to evaluate the safety and performance of the MTMM bi-directional cannula in patients requiring peripheral cannulation for Cardiac Surgery.
Alfred Hospital0 个研究点目标入组 15 人开始时间: 2015年9月28日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
研究概览
简要总结
This trial demonstrates that the novel bi-directional cannula is safe and easy to insert in the femoral artery and provides stable blood flow down the leg during cardiopulmonary bypass. The use of this device should largely remove the need to insert a separate cannula to provide blood flow down the leg, or use other techniques to protect against insufficient blood flow.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •1. Patients may be male or female
- •2. Patients must be 18 years or over and not more than 80 years of age.
- •3. Patients must be assessed as requiring cardiac surgery with cardiopulmonary bypass support by a cardio-thoracic surgeon.
- •4. Patients must weigh greater than 45kg and less than 130kg.
- •5. Site personnel must obtain informed consent from the patient prior to any study procedures (including screening procedures).
排除标准
- •1. Patients who have undergone previous vascular surgery of the femoral artery.
- •2. Patients requiring emergency cardiac surgery including Type A aortic dissections.
- •3. Patients where the internal diameter of the common femoral artery is not greater than 0.6cm.
- •4. Concurrent enrollment in another investigational drug or device study, or use of any experimental or investigational drug or device within 30 days of cardiopulmonary bypass support.
- •5. Any other medical condition which in the view if the Investigator is likely to interfere with the study or put the patient at risk.
- •6. Patients who the investigator feels will not achieve adequate flow rates and line pressures due to the patient's weight and body surface area.
研究者
相似试验
已完成
1 期
Safety and Feasibility Study of Dapivirine (TMC120) Vaginal Ring in BelgiumHIV InfectionsNCT00332995International Partnership for Microbicides, Inc.13
已完成
2 期
Safety and Efficacy of a Metallic Cannula Versus A Standard Needle for Soft Tissue Augmentation of the Nasolabial FoldsWrinklesNCT01066026Brazilan Center for Studies in Dermatology25
已完成
1 期
Safety Study of Antria Cell Preparation Process to Enhance Facial Fat Grafting With Adipose Derived Stem CellsLipoatrophyAgingWrinklesNCT01828723Antria6
已完成
1 期
Safety/Feasibility of Vonapanitase Following Angioplasty for Patients With Peripheral Artery Disease (PAD) Below the Knee (BTK)Peripheral Artery DiseaseNCT02956993Proteon Therapeutics29
已完成
不适用
Post Market Clinical Study to Evaluate a Mid-Urethral Vaginal Tape Procedure With a Pre-Pubic Delivery Approach, for the Treatment of Stress Urinary IncontinenceIntrinsic Sphincter DeficiencyStress Urinary IncontinenceNCT00688298Boston Scientific Corporation100