Prospective, Trial Evaluating the Safety and Effectiveness of the Interscope Endorotor® System for Direct Endoscopic Necrosectomy of Walled Off Pancreatic Necrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 20
- 主要终点
- Safety: Number of Participants With Device Related Complications
研究概览
简要总结
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 (DEN) with walled off pancreatic necrosis (WOPN).
详细描述
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). 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who are >22; inclusive of males and females.
- •Patients with symptomatic pancreatic necrosis due to acute pancreatitis that have an indication to undergo endoscopic necrosectomy after having undergone EUS-guided drainage
- •Imaging suggestive of greater than or equal to 30% necrotic material
- •Walled off pancreatic necrosis size ≥6 cm and ≤22cm
- •Subject can tolerate repeated endoscopic procedures
- •Subject capable of giving informed consent.
- •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.
排除标准
- •Subject unable to give informed consent.
- •Subject is unwilling to return for repeated endoscopies.
- •Documented Pseudoaneurysm > 1cm within the WOPN
- •Intervening gastric varices or unavoidable blood vessels within the access tract (visible using endoscopy or endoscopic ultrasound).
- •Dual antiplatelet therapy or therapeutic anticoagulation that cannot be withheld for the procedure
- •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).
- •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.
- •Patient is known to be currently enrolled in another investigational trial that could interfere with the endpoint analyses of this trial.
结局指标
主要结局
Safety: Number of Participants With Device Related Complications
时间窗: 21 +/- 7 Days
The primary endpoint of this study is the freedom from major device related 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.
次要结局
- Mean Length of Hospital Stay Per Participant(At patient discharge from hospital)
- Effectiveness: Number of Participants With at Least 70% of Necrotic Debris Removed(21 +/- 7 Days)
- Mean Number of Necrosectomy Procedures Required Per Participant to Achieve at Least 70% Reduction in Necrosis.(This outcome was assessed at completion of all necrosectomy procedures per participant. After completion of all necrosectomy procedures in all participants the overall mean number of procedures to achieve at least 70% reduction in necrosis was calculated.)
- Mean Total Procedure Time to Achieve at Least 70% Reduction in Necrosis(Completion of all necrosectomy procedures per patient)
- Adequacy of Procedural Debridement: Mean Percent Necrotic Material Removed From the WOPN Cavity Per Procedure.(This outcome was assessed at the completion each necrosectomy procedure per participant. At the completion of all necrosectomy procedures for all participants, an overall mean percent necrotic material removed from the WOPN per procedure was calculated.)
- Quality of Life - Short Form 36-Item Health Survey Version 1 (SF-36v1), Physical & Emotional Composite Score(21 +/- 7 Days)