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Novel Rigidizing Overtube in Colonic Endoscopic Submucosal Dissection

NCT06134687 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2026-03-24

No results posted yet for this study

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

Interventions

PROCEDURE

Endoscopic Submucosal Dissection

Removal of study eligible lesions per endoscopic submucosal dissection

DEVICE

Novel Rigidizing Overtube

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

Sponsors & Collaborators

  • Neptune Medical, Inc.

    collaborator UNKNOWN

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Mohamed Othman, MD · Baylor College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-04
Primary Completion
2026-12-04
Completion
2027-05-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06134687 on ClinicalTrials.gov