NL-OMON41690已完成不适用
A NON-RANDOMIZED, MULTI-CENTER, PROSPECTIVE, SINGLE ARM CLINICAL STUDY OF THE X-SUIT NIR® COVERED BILIARY METALLIC STENT FOR PALLIATION OF MALIGNANT STRICTURES IN THE BILIARY TREE VIA ENDOSCOPIC APPROACH - X-MAS BILIARY STUDY, PROTOCOL # BI-03-01
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Medinol Ltd
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Age 18 or older.
- •2. Clinical symptoms of biliary obstruction.
- •3. Presence of inoperable extrahepatic distal biliary obstruction by any
- •malignant process (the subject not being a surgical candidate based on
- •the finding of a pancreatic mass >2.0cm or a severe medical illness).
- •Malignancy is defined as:
- •A tissue diagnosis (biliary brushing or percutaneous biopsy, EUS,
- •Elevated serum tumor markers (CEA, CA19-9, AFP), or
- •Presence of liver metastasis per CT scan or MRI.
- •4. .Subject is willing and able to comply with the study procedures and
- •provide written informed consent to participate in the study
排除标准
- •The subject must not meet any of the following exclusion criteria:
- •1. Participation in an Investigational Study within 30 days prior to date of subject consent.
- •2. Perforation of any duct within the biliary tree.
- •3. Presence of more than three previously implanted plastic stent.
- •4. Plastic stent implantation less than 2 weeks prior to current procedure.
- •5. Presence of a metal biliary stent.
- •6. Presence of any esophageal or duodenal stent.
- •7. Previous Bilroth II or Roux-en-Y gastric resection, a significant duodenal obstruction or any other altered anatomy which could prevent access to ampulla.
- •8. Subjects for whom endoscopic procedures are contraindicated.
- •9. Subjects with known sensitivity to any components of the stent or delivery system.
- •10. Subjects with active hepatitis or other hepatic diseases that may cause jaundice.
- •11. Subjects with a WHO performance score of 4- Bedbound (completely disabled, cannot carry on any self-care, totally confined to bed or chair).
- •12. Pregnant women and breast-feeding women.
- •13. Subjects considered to be vulnerable i.e. prisoners and individuals with impaired consent capacity and/or lack or loss of autonomy.;Cholangiographic exclusion criterion:
- •14. Strictures that cannot be passed by the guide wire or the delivery system.
研究者
相似试验
撤回
不适用
A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Clinical Study to Demonstrate the Safety and Performance of the Leaflex* PerformerAortic StenosisNL-OMON55148Pi-Cardia Ltd.10
已完成
不适用
A Prospective, Multi-Center, Non-Randomized, Single-Arm Study of the BARD® LIFESTREAM™ Balloon Expandable Vascular Covered Stent in the Treatment of Iliac Artery Occlusive Disease (BOLSTER)I70.2Atherosclerosis of arteries of extremitiesDRKS00006828Bard Peripheral Vascular, Inc.154
已完成
2 期
A Prospective, Multi-Center, Non-randomized, Single arm, Open label, Pivotal Study to Evaluate the Safety and Effectiveness of the NovaCross* Micro-catheter in Facilitating Crossing Chronic Total Occlusion (CTO) Coronary Lesions.PCI CTOstenosis1001108210003216NL-OMON41722itiloop Ltd.50
已完成
不适用
Prospective, multicenter, non-randomized, single-arm observational study to evaluate safety and effectiveness of iCover covered stent for the treatment of the aorto-iliac Occlusive DiseaseAorto-Iliacal ArtheropathyDRKS00028124IVascular240
暂停
不适用
This study is done to assess Effectiveness and Safety study of a three drug combination with a two drug combination for the treatment of type 2 diabetes mellitus in patients who have never received insulin.CTRI/2011/06/001841Abbott India Limited70