NCT06134687

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
13mo left

Started Jun 2024

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Jun 2024May 2027

First Submitted

Initial submission to the registry

November 10, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

June 4, 2024

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2027

Last Updated

March 24, 2026

Status Verified

August 1, 2025

Enrollment Period

2.5 years

First QC Date

November 10, 2023

Last Update Submit

March 20, 2026

Conditions

Gastrointestinal Neoplasm

Keywords

Endoscopic Submucosal Dissection

Outcome Measures

Primary Outcomes (1)

  • Total Procedure Time

    Total Procedure Time to perform ESD from scope in to scope out

    Day 1 (procedure day)

Secondary Outcomes (8)

  • Navigation Time

    Day 1 (procedure day)

  • Technical Success

    Day 1 (procedure day)

  • Clinical Success

    Day 1 (procedure day)

  • En-bloc, R0, and curative resection rates

    Day 1 (procedure day)

  • Dissection speed during colonic ESD as calculated by

    Day 1 (procedure day)

  • +3 more secondary outcomes

Study Arms (2)

Treatment arm

EXPERIMENTAL

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

Procedure: Endoscopic Submucosal DissectionDevice: Novel Rigidizing Overtube

Control arm

ACTIVE COMPARATOR

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

Procedure: Endoscopic Submucosal Dissection

Interventions

Endoscopic Submucosal DissectionPROCEDURE

Removal of study eligible lesions per endoscopic submucosal dissection

Also known as: ESD, Endoscopic resection
Control armTreatment arm
Novel Rigidizing OvertubeDEVICE

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

Treatment arm

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

Baylor St. Lukes Medical Center (BSLMC)

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Mohamed Othman, MD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Mercado, BS

CONTACT

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

Sara Al Yasin, BS

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 10, 2023

First Posted

November 18, 2023

Study Start

June 4, 2024

Primary Completion (Estimated)

December 4, 2026

Study Completion (Estimated)

May 30, 2027

Last Updated

March 24, 2026

Record last verified: 2025-08

Locations

US(2)