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GelPOINT® Path-Assisted Endoscopic Removal of Colon and Rectal Polyps: A Feasibility and Safety Study

2026年7月20日 更新者：Tara Keihanian、Baylor College of Medicine

GelPOINT® Path-Assisted Endoscopic Submucosal Dissection for Colorectal Polyps: A Feasibility and Safety Study

This prospective, single-center, observational feasibility and safety study will evaluate the use of the GelPOINT® Path transanal access platform during endoscopic submucosal dissection (ESD) for the removal of colorectal polyps. The GelPOINT® Path system is designed to improve access, maintain stable insufflation, and enhance visualization during advanced endoscopic procedures.

The study will enroll adult patients undergoing ESD for eligible colorectal lesions. The primary objective is to evaluate the technical feasibility, procedural performance, and safety of GelPOINT® Path-assisted ESD. Procedural outcomes, including procedure speed, technical success, resection outcomes, and procedure-related adverse events, will be collected prospectively. Participants will receive standard clinical care and will be followed for approximately 4 weeks after the procedure to assess delayed adverse events.

研究概览

地位

招聘中

条件

详细说明

Endoscopic submucosal dissection (ESD) is an advanced endoscopic technique that enables en bloc removal of large or complex colorectal lesions while preserving the bowel and reducing the need for surgical resection. Despite its advantages, colorectal ESD remains technically demanding because of limited visualization, unstable luminal distension, and restricted instrument maneuverability, particularly in the distal colon and rectum.

The GelPOINT® Path transanal access platform has been widely used in transanal minimally invasive surgery (TAMIS) to provide stable insufflation and improved access for rectal procedures. This study will evaluate whether incorporating the GelPOINT® Path platform into colorectal ESD can improve procedural efficiency while maintaining the safety and effectiveness of standard ESD.

This is a prospective, single-center, observational feasibility and safety study enrolling approximately 30 adult patients undergoing ESD for eligible colorectal lesions. All procedures will be performed by experienced advanced endoscopists as part of routine clinical care. The use of the GelPOINT® Path platform will be determined by the treating physician according to standard clinical practice. No experimental therapeutic interventions or deviations from routine clinical management will occur.

Clinical, procedural, pathological, and follow-up data will be collected prospectively using standardized case report forms. Outcomes will include technical success, procedure time, dissection speed, en bloc resection, R0 resection, curative resection, device performance, operator workload, and intraprocedural and delayed adverse events. Participants will be followed for approximately 4 weeks after the procedure to evaluate post-procedural safety.

The findings from this study are expected to provide important feasibility and safety data regarding the use of the GelPOINT® Path platform as an adjunct to colorectal ESD and may help guide the design of future comparative studies evaluating its clinical effectiveness.

研究类型

观察性的

注册 (估计的)

30

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。

学习联系方式

学习地点

  • 美国
    • Texas
      • Houston、Texas、美国、77030
        • 招聘中
        • Baylor College of Medicine
        • 副研究员：
          • Mohamed Othman, MD
        • 副研究员：
          • Fares Ayoub, MD
        • 接触：
        • 接触：

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

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Adult patients referred for endoscopic submucosal dissection (ESD) of eligible colorectal neoplastic lesions located in the transverse colon, descending colon, rectosigmoid colon, or rectum who meet all study eligibility criteria and provide written informed consent.

描述

Inclusion Criteria:

  • Adults aged 18 years or older.
  • Able and willing to provide written informed consent.
  • Colorectal polyps located in the transverse colon, descending colon, rectosigmoid colon, or rectum (rectal lesions located at least 2 cm from the anal verge).
  • Referred for endoscopic submucosal dissection (ESD) of colorectal neoplastic lesions meeting at least one of the following criteria:
  • Lesions with prior resection or scarring proximal to the sigmoid colon.
  • Granular lateral spreading tumors (GLST) >30 mm.
  • Non-granular lateral spreading tumors (NGLST) >20 mm.
  • Lesions with suspected submucosal invasion, including Paris classification IIa+IIc lesions or lesions with a positive non-lifting sign

Exclusion Criteria:

  • Younger than 18 years of age.
  • Unable or unwilling to provide informed consent.
  • Pregnant.
  • Pedunculated lesions (Paris classification Ip or Isp).
  • Lesions involving the appendix or ileocecal valve

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

队列和干预

团体/队列
GelPOINT® Path-Assisted ESD
Adult participants undergoing endoscopic submucosal dissection (ESD) for eligible colorectal polyps using the GelPOINT® Path transanal access platform as part of standard clinical care. The study will prospectively evaluate the feasibility, technical performance, and safety of GelPOINT® Path-assisted ESD, including procedural outcomes and procedure-related adverse events.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Procedure Speed
大体时间：During the index procedure
Procedure speed, calculated as lesion surface area (cm²) divided by total procedure time (hours), to evaluate the technical performance of GelPOINT® Path-assisted endoscopic submucosal dissection.
During the index procedure

次要结果测量

结果测量
措施说明
大体时间
En Bloc Resection Rate
大体时间：During the index procedure
Percentage of lesions resected en bloc (in a single piece).
During the index procedure
Complete (R0) Resection Rate
大体时间：Pathology assessment following the index procedure (within approximately 2 weeks)
Percentage of lesions with histologically negative lateral and vertical margins following resection.
Pathology assessment following the index procedure (within approximately 2 weeks)

其他结果措施

结果测量
措施说明
大体时间
Intraprocedural Adverse Events
大体时间：During the index procedure
Incidence of intraprocedural adverse events, including muscularis propria injury, perforation, and bleeding.
During the index procedure
Post-Procedural Adverse Events
大体时间：Up to 4 weeks after
Incidence of delayed adverse events, including delayed bleeding, perforation, post-polypectomy syndrome, and other procedure-related complications.
Up to 4 weeks after

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。

赞助

Baylor College of Medicine

调查人员

  • 首席研究员：Tara Keihanian, MD、Baylor College of Medicine

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)

2026年5月19日

初级完成 (估计的)

2027年3月25日

研究完成 (估计的)

2027年4月30日

研究注册日期

首次提交

2026年7月20日

首先提交符合 QC 标准的

2026年7月20日

首次发布 (实际的)

2026年7月23日

研究记录更新

最后更新发布 (实际的)

2026年7月23日

上次提交的符合 QC 标准的更新

2026年7月20日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

其他研究编号

  • H-59028

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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.

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