Novel Rigidizing Overtube in Colonic Endoscopic Submucosal Dissection

Description

The goal of this prospective, single centre, 1:1, Post Market, randomized controlled, Investigator Initiated trial, is to compare the feasibility, safety efficacy, and clinical outcomes of colonic endoscopic submucosal dissection (ESD) utilizing a novel rigidizing overtube called Pathfinder® Endoscope Overtube (Neptune Medical, Burlingame California, USA) device in comparison to conventional ESD. The research team hypothesize that with utilizing a novel rigidizing overtube the procedure time including dissection speed and closure time will be faster due to higher scope stability and greater control over the scope tip. Subsequently, the investigators anticipate lower immediate or delayed adverse events.

Conditions

Gastrointestinal Neoplasm

Study Overview

Study Details

Study overview

The goal of this prospective, single centre, 1:1, Post Market, randomized controlled, Investigator Initiated trial, is to compare the feasibility, safety efficacy, and clinical outcomes of colonic endoscopic submucosal dissection (ESD) utilizing a novel rigidizing overtube called Pathfinder® Endoscope Overtube (Neptune Medical, Burlingame California, USA) device in comparison to conventional ESD. The research team hypothesize that with utilizing a novel rigidizing overtube the procedure time including dissection speed and closure time will be faster due to higher scope stability and greater control over the scope tip. Subsequently, the investigators anticipate lower immediate or delayed adverse events.

Prospective Single Centre, Post Market, Randomized Controlled Trial to Demonstrate Feasibility, Safety and Efficacy, of a Novel Rigidizing Overtube in Colonic Endoscopic Submucosal Dissection

Novel Rigidizing Overtube in Colonic Endoscopic Submucosal Dissection

Condition
Gastrointestinal Neoplasm
Intervention / Treatment

-

Contacts and Locations

Houston

Baylor College of Medicine, Houston, Texas, United States, 77030

Houston

Baylor St. Lukes Medical Center (BSLMC), Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Patient is ≥ 22 years old.
  • * Patients can provide written informed consent.
  • * Patient is referred for ESD procedure of colonic neoplastic lesions and with one of the following criteria:
  • * Patient refused and/or unable to provide written informed consent.
  • * Patient is a pregnant or nursing woman.
  • * Lesions with morphology: pedunculated type (Paris Ip, Ips).
  • * Lesions located within the sigmoid colon or rectum.
  • * Lesions involving appendiceal orifice or ileocecal valve

Ages Eligible for Study

22 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Baylor College of Medicine,

Mohamed Othman, MD, PRINCIPAL_INVESTIGATOR, Baylor College of Medicine

Study Record Dates

2025-07-31