GelPOINT® Path-Assisted Endoscopic Removal of Colon and Rectal Polyps: A Feasibility and Safety Study
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.
Обзор исследования
Статус
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.
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: Tara Keihanian, MD
- Номер телефона: 631-800-4142
- Электронная почта: Tara.Keihanian@bcm.edu
Места учебы
-
-
Texas
-
Houston, Texas, Соединенные Штаты, 77030
- Рекрутинг
- Baylor College of Medicine
-
Младший исследователь:
- Mohamed Othman, MD
-
Младший исследователь:
- Fares Ayoub, MD
-
Контакт:
- Haydee Rochits Cueto
- Номер телефона: 713-798-3606
- Электронная почта: Haydee.RochitsCueto@bcm.edu
-
Контакт:
- Tara A Keihanian, MD
- Номер телефона: 631-800-4142
- Электронная почта: Tara.Keihanian@bcm.edu
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Метод выборки
Исследуемая популяция
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
|---|
|
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.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Procedure Speed
Временное ограничение: 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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
En Bloc Resection Rate
Временное ограничение: During the index procedure
|
Percentage of lesions resected en bloc (in a single piece).
|
During the index procedure
|
|
Complete (R0) Resection Rate
Временное ограничение: 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)
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Intraprocedural Adverse Events
Временное ограничение: During the index procedure
|
Incidence of intraprocedural adverse events, including muscularis propria injury, perforation, and bleeding.
|
During the index procedure
|
|
Post-Procedural Adverse Events
Временное ограничение: 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
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Tara Keihanian, MD, Baylor College of Medicine
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- H-59028
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .