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Study on a New Endoscopic Platform for the ESD of Colorectal Lesions: Tissue Retraction System (TRS)

2021年3月17日 更新者:Istituto Clinico Humanitas

Pilot Study on a New Endoscopic Platform for the ESD of Colorectal Lesions: Tissue Retraction System

Endoscopic submucosal dissection (ESD) is an endoscopic technique that allows the removal of lesions of the gastrointestinal tract. The European Society of Gastrointestinal Endoscopy (ESGE) suggests to consider ESD for the removal of colorectal lesions that cannot be removed enbloc with standard polypectomy or endoscopic mucosal resection (EMR) and for lesions that are > 20 mm in diameter, with a high probability of having a limited submucosal invasion.

ESD is a technically difficult and time-consuming procedure that is very difficult to learn and to perform, but it allows higher enbloc resection rates compared to other endoscopic techniques and is less invasive than surgery requiring less length of hospital stay.

Recently, several new techniques and devices have been developed to facilitate ESD and to overcome difficulties related to challenging situations. The main difficulties are related to the instability of the operating field, due to the physiologic peristalsis, and to the loss of traction, due to the single operating channel.

研究概览

详细说明

Tissue Retraction System (TRS, Boston scientific) is a new endoscopic platform, that consists of an expandable and dynamically-controlled intra-luminal chamber, mounted on a flexible overtube, and two associated specifically designed retractor graspers. The system is front-loaded over the colonoscope and introduced into the colon. When the target area is reached, the retractor system is deployed creating an expanded, optimally reconfigured and stable operating field around the target lesion. Then endoscopic removal of the lesion is performed using available endoscopic instruments (injection needles, knives, snares, etc) through the operating channel of the colonoscope with assistance of two retractor graspers. Each accessory within the TRS can be moved forward and backward, left or right, rotated 360 degrees, and can be advanced out and pulled in, regardless of the TRS.

The investigators hypothesize that the TRS can improve visualization of lesions and stabilize the work environment by allowing retraction and tissue resection during ESD.

TRS is a new device not yet commercially available, thus no study has been already performed in humans to evaluate its feasibility and safety to speed up the ESD of left colon and rectum lesions.

The investigator's proposal is to perform a pilot study to evaluate the feasibility, the efficacy and the safety in patients undergoing ESD of colorectal lesions with the assistance of the TRS.

研究类型

介入性

注册 (实际的)

15

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Rozzano、意大利、20089
        • Humanitas Research Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • left colon and rectal lesions matching the criteria of ESD removal: depressed/flat elevated morphology and irregular or nongranular surface pattern, larger than 20 mm; lesions that cannot be optimally and radically removed with standard polypectomy or EMR
  • age ≥18 years
  • ability to sign the informed consent

Exclusion Criteria:

  • deep submucosal invasion diagnosed by distorted pit (Kudo's type V) and/or capillary (Sano's type III) patterns [5];
  • poor general condition (American Society of Anesthesiologists score ≥ 3);
  • coagulation disorders;
  • pregnancy and breastfeeding;
  • inability to sign the informed consent.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:TRS
TRS, Tissue resection system
Tissue Retraction System

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Primary endpoint is the feasibility, defined as the technical success rate, to perform an enbloc ESD with the assistance of the TRS.
大体时间:9 months
9 months

次要结果测量

结果测量
大体时间
Secondary endpoints are: the efficacy, defined as the rate of lesions removed enbloc and the rate of curative ESD (with an R0 resection); the safety, defined as the rate of adverse events (AEs).
大体时间:12 months
12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年5月28日

初级完成 (实际的)

2020年12月31日

研究完成 (实际的)

2020年12月31日

研究注册日期

首次提交

2018年5月29日

首先提交符合 QC 标准的

2018年6月11日

首次发布 (实际的)

2018年6月12日

研究记录更新

最后更新发布 (实际的)

2021年3月18日

上次提交的符合 QC 标准的更新

2021年3月17日

最后验证

2021年3月1日

更多信息

与本研究相关的术语

其他研究编号

  • TRS

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

是的

在美国制造并从美国出口的产品

是的

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

TRS, Tissue Retraction System的临床试验

3
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