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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Tara Keihanian, MD
- Numéro de téléphone: 631-800-4142
- E-mail: Tara.Keihanian@bcm.edu
Lieux d'étude
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Texas
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Houston, Texas, États-Unis, 77030
- Recrutement
- Baylor College of Medicine
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Sous-enquêteur:
- Mohamed Othman, MD
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Sous-enquêteur:
- Fares Ayoub, MD
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Contact:
- Haydee Rochits Cueto
- Numéro de téléphone: 713-798-3606
- E-mail: Haydee.RochitsCueto@bcm.edu
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Contact:
- Tara A Keihanian, MD
- Numéro de téléphone: 631-800-4142
- E-mail: Tara.Keihanian@bcm.edu
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Procedure Speed
Délai: During the index procedure
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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.
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During the index procedure
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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En Bloc Resection Rate
Délai: During the index procedure
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Percentage of lesions resected en bloc (in a single piece).
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During the index procedure
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Complete (R0) Resection Rate
Délai: Pathology assessment following the index procedure (within approximately 2 weeks)
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Percentage of lesions with histologically negative lateral and vertical margins following resection.
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Pathology assessment following the index procedure (within approximately 2 weeks)
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
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Intraprocedural Adverse Events
Délai: During the index procedure
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Incidence of intraprocedural adverse events, including muscularis propria injury, perforation, and bleeding.
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During the index procedure
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Post-Procedural Adverse Events
Délai: Up to 4 weeks after
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Incidence of delayed adverse events, including delayed bleeding, perforation, post-polypectomy syndrome, and other procedure-related complications.
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Up to 4 weeks after
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Tara Keihanian, MD, Baylor College of Medicine
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- H-59028
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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