Идёт набор NCT07723937

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

— Наблюдательное Polyp Colorectal Rectal Adenoma Adenoma Colon Polyp

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Polyp Colorectal, Rectal Adenoma, Adenoma Colon Polyp. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

Procedure Speed [Срок оценки: During the index procedure]

Вторичные конечные точки (2)

En Bloc Resection Rate [Срок оценки: During the index procedure]
Complete (R0) Resection Rate [Срок оценки: Pathology assessment following the index procedure (within approximately 2 weeks)]

Критерии участия

Критерии включения

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