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.
Panoramica dello studio
Stato
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Tara Keihanian, MD
- Numero di telefono: 631-800-4142
- Email: Tara.Keihanian@bcm.edu
Luoghi di studio
-
-
Texas
-
Houston, Texas, Stati Uniti, 77030
- Reclutamento
- Baylor College of Medicine
-
Sub-investigatore:
- Mohamed Othman, MD
-
Sub-investigatore:
- Fares Ayoub, MD
-
Contatto:
- Haydee Rochits Cueto
- Numero di telefono: 713-798-3606
- Email: Haydee.RochitsCueto@bcm.edu
-
Contatto:
- Tara A Keihanian, MD
- Numero di telefono: 631-800-4142
- Email: Tara.Keihanian@bcm.edu
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
|---|
|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Procedure Speed
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
En Bloc Resection Rate
Lasso di tempo: During the index procedure
|
Percentage of lesions resected en bloc (in a single piece).
|
During the index procedure
|
|
Complete (R0) Resection Rate
Lasso di tempo: 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)
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Intraprocedural Adverse Events
Lasso di tempo: During the index procedure
|
Incidence of intraprocedural adverse events, including muscularis propria injury, perforation, and bleeding.
|
During the index procedure
|
|
Post-Procedural Adverse Events
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Tara Keihanian, MD, Baylor College of Medicine
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- H-59028
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .