Recruiting

Observational Study

Sponsor:

Baylor College of Medicine

Code:

NCT06134687

Conditions

Gastrointestinal Neoplasm

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Endoscopic Submucosal Dissection

Novel Rigidizing Overtube

Study Details

Brief summary:

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 ID

NCT06134687

Start date

Jun 4, 2024

Status verified date

Aug, 2025

Completion date

May 30, 2027

Anticipated

Primary completion date

Dec 4, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Inclusion 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:

A - Lesions with prior resection or with scar at any size proximal to the sigmoid colon.

B - Granular lateral spreading tumors (GLST) more than 30mm. C - Non granular lateral spreading tumors (NGLST) more than 20 mm. D - Any suspected submucosal invasion such as Paris classification II a +II or lesions with positive non lifting sign.

Exclusion 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

Study Design

Enrollment

66 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Treatment arm

Will have endoscopic submucosal dissection performed with the use of the Pathfinder Endoscope Overtube.

active comparator: Control arm

Will have endoscopic submucosal dissection performed through conventional means (i.e. without the Pathfinder Endoscope Overtube).

Interventions

Endoscopic Submucosal Dissection

Removal of study eligible lesions per endoscopic submucosal dissection

Novel Rigidizing Overtube

Utilization of the Novel Rigidizing Overtube (Pathfinder) to aid in performing colonic endoscopic submucosal dissection

Primary outcome measure

  • Total Procedure Time [ Time Frame: Day 1 (procedure day) ]

Central Contacts and Locations

Central contacts

Michael Mercado, BS

713-798-3606Michael.Mercado@bcm.edu

Sara Al Yasin, BS

713-798-2308Sara.AlYasin@bcm.edu

Locations

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Mohamed O. Othman, MD

713-798-0950Mohamed.Othman@bcm.edu

Baylor St. Lukes Medical Center (BSLMC)

Recruiting

Houston, Texas, United States, 77030

Contacts

Mohamed O. Othman, MD

713-798-0950Mohamed.Othman@bcm.edu

Michael Mercado

7137983606Michael.Mercado@bcm.edu

More Information

Sponsor

Baylor College of Medicine

Last update posted

Mar 24, 2026

Last verified

Aug, 2025

Keywords

  • Endoscopic Submucosal Dissection

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Baylor College of Medicine on 2026-03-24.