EndoRotor DEN (Direct Endoscopic Necrosectomy)Trial

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追踪信息

首次提交日期 ^ICMJE

September 26, 2018

首次发布日期e ^ICMJE

October 3, 2018

最后更新发布日期

October 3, 2018

预计研究开始日期 ^ICMJE

October 1, 2018

预计主要完成日期

November 15, 2018 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Safety: Rate of major complications[ Time Frame: 21 +/- 7 Days ]

The primary endpoint of this study is the freedom from major complications. The safety endpoint will include an assessment of the safety of the EndoRotor when performing endoscopic necrosectomy. For the purpose of this study, the safety evaluation shall include complications associated with endoscopic necrosectomy through the 21 (+/-7) day follow-up period. Potential endoscopic complications include perforation and bleeding.

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Effectiveness: Percentage of necrosis removed measured by CT Scan[ Time Frame: 21 +/- 7 Days ]
Successful clearance of necrosis in the collection being treated during direct endoscopic necrosectomy where success is defined as at least 70% of the necrotic debris in the collection being treated is removed based on CT evaluation of the cavity at the 21 (+/-7) day day follow up visit.
Procedure Time: Record each procedure time[ Time Frame: 14 Days ]
Assessment of total procedure time to achieve clearance of necrosis for all procedures.
Adequacy of Procedural Debridement: Visual estimation of percent removal of necrosis from the site based on endoscopic view[ Time Frame: 14 Days ]
At conclusion of the procedure, the percent removal of the total necrosis present will be visually estimated by the Investigator as a measure of removal adequacy with the EndoRotor
Number of Procedures: Record total number of procedures to achieve clearance[ Time Frame: 14 Days ]
Assessment of total number of procedures to achieve clearance of necrosis.
Hospital Resource Utilization: Total length of hospital stay[ Time Frame: 21 +/- 7 Days ]
The total length of hospital stay measured from the first use of the EndoRotor to study exit at the 21 day follow up visit will be used to determine potential economic advantages of the EndoRotor procedure.
Quality of Life - SF-36v2 Health Survey, Physical Composite Score[ Time Frame: 21 +/- 7 Days ]
Evaluation of Physical Component Score for improved quality of life. Score will be reported on a scale of 0-100 with improvement demonstrated by a higher score above the mean value of 50
Quality of Life - SF-36v2 Health Survey, Mental Composite Score[ Time Frame: 21 +/- 7 Days ]
Evaluation of Mental Component Score for improved quality of life. Score will be reported on a scale of 0-100 with improvement demonstrated by a higher score above the mean value of 50

描述性信息

简略标题 ^ICMJE

EndoRotor DEN (Direct Endoscopic Necrosectomy)Trial

正式标题 ^ICMJE

Prospective, Trial Evaluating the Safety and Effectiveness of the Interscope Endorotor® System for Direct Endoscopic Necrosectomy of Walled Off Pancreatic Necrosis

简要概况

详细说明

A prospective, single arm, open label, multi-center, trial to evaluate the safety and effectiveness of the Interscope EndoRotor® Resection System in subjects requiring direct endoscopic necrosectomy with walled off pancreatic necrosis (WOPN). Total enrollment 30 subjects with at least 15 enrolled in the US. Subjects will be debrided with the EndoRotor either at the time of stent placement or post placement at Investigator's discretion with a maximum of 4 EndoRotor procedures. A minimum of 2 days is required between each EndoRotor procedure and all procedures need to be completed within a 14 (+7/-0) day period. Follow up is completed 21 (+/- 7) days after last EndoRotor debridement procedure.

研究类型 ^ICMJE

Interventional

研究阶段

N/A

研究设计 ^ICMJE

分配:
干预模型: Single Group Assignment
干预模型描述: A prospective, single arm, open label, multi-center, trial to evaluate the safety and effectiveness of the Interscope EndoRotor® Resection System in subjects requiring direct endoscopic necrosectomy with walled off pancreatic necrosis (WOPN).
盲法: Interventional
盲法描述:
主要目的: Other

适用条件 ^ICMJE

干预项目 ^ICMJE

Device: EndoRotor Therapy
To evaluate the EndoRotor's ability to safely remove non-viable/necrotic tissue for direct endoscopic necrosectomy in patients with walled off pancreatic necrosis.

研究工具

Experimental: EndoRotor Therapy
Physicians will perform direct endoscopic necrosectomy using the EndoRotor in patients with walled off necrosis.

招募信息

招募状态 ^ICMJE

Not yet recruiting

预计入组 ^ICMJE

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

December 15, 2018

预计主要完成日期

November 15, 2018 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: 1. Subjects who are >22; inclusive of males and females. 2. Patients with symptomatic pancreatic necrosis due to acute pancreatitis that have an indication to undergo endoscopic necrosectomy after having undergone EUS-guided drainage 3. Imaging suggestive of greater than or equal to 30% necrotic material 4. Walled off pancreatic necrosis size ≥6 cm and ≤22cm 5. Subject can tolerate repeated endoscopic procedures 6. Subject capable of giving informed consent. 7. Subjects with the ability to understand the requirements of the study, who have provided written informed consent, and who are willing and able to return for the required follow-up assessments through 21 (+/- 7) days, as indicated. Exclusion Criteria: 1. Subject unable to give informed consent. 2. Subject is unwilling to return for repeated endoscopies. 3. Documented Pseudoaneurysm > 1cm within the WOPN 4. Intervening gastric varices or unavoidable blood vessels within the access tract (visible using endoscopy or endoscopic ultrasound). 5. Dual antiplatelet therapy or therapeutic anticoagulation that cannot be withheld for the procedure 6. Any condition that in the opinion of the investigator would create an unsafe clinical situation that would not allow the patient to safely undergo an endoscopic procedure (lack of medical clearance). 7. Pregnant or lactating women or women of childbearing potential who do not employ a reliable method of contraception as judged by the Investigator, and/or are not willing to use reliable contraception for the duration of study participation. 8. Patient is known to be currently enrolled in another investigational trial that could interfere with the endpoint analyses of this trial.

性别

参与研究的性别:

All

年龄

最小年龄：22 Years ，最大年龄：N/A

接受健康的志愿者

没有

可入组国家 ^ICMJE

Germany|Netherlands|United States

管理信息

数据检测委员会

Yes

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: Yes

IPD 共享声明

计划分享 IPD:

Undecided

责任方

，

研究赞助商 ^ICMJE

Interscope, Inc.

合作者 ^ICMJE

研究员 ^ICMJE

Principal Investigator: Marco Bruno, MD PhD Erasmus Medical Center

PRS 账户

验证日期

September 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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