Novel Rigidizing Overtube in Colonic Endoscopic Submucosal Dissection

NCT ID: NCT06134687

Last Updated: 2025-08-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-04
• Study Completion Date: 2025-10-30

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.

Detailed Description

Endoscopic submucosal dissection (ESD) is preferred resection method for advanced colonic polyp due to its higher rates of en bloc and R0 resection which lead to higher curative resection rate.1 In comparison to gastric ESD, colonic ESD is more challenging due to colonic unique anatomy and configuration. Tumor of size ≥ 50 mm, spreading across ≥ two folds, flexure locations have been described as strong predictors for difficulties during colonic ESD.2 Redundant colon and looping during colonoscopy may preclude successful advancement of the colonoscope and maintaining stable position for complex polyp removal.

Historically, various methods have been applied to facilitate colonoscopy and scope advancement in challenging positions and redundant colonic loops such as application of external pressure, exchange to pediatric colonoscope, torque-based reduction maneuvers, and patient repositioning. However, despite these, scope tip stabilization could potentially remain as a challenging and limiting factor for procedure progress and could lead to a longer procedure time, sedation time and perhaps lower procedure success rate. In comparison overtube-assisted colonoscopy allows for straightening of the colon to decrease angulation and loop formation.3 Several variations of overtubes have been put to use in the last few decades with comparable results such as single-balloon and double-balloon enteroscope, spiral overtube-assisted colonoscopy and double-balloon platform (DiLumenTM). DiLumen system consists of a plastic sheet fitting layer with two balloon few inches from each other in the tip of the device facilitating the scope tip stability. Most recently the efficacy of DiLumen platform were evaluated in a multicenter study including 162 patients who underwent endoscopic resection of advanced polyps.4 In this study technical success was achieved in 92% of patients without any device related adverse event. 4 In this study using an overtube resulted in faster and more efficient dissection.4 In a retrospective study of 88 polyps located within the proximal colon, ESD with assistance of traditional single balloon overtube resulted in significantly less perforation rate in polyps ≥ 40mm in the proximal colon, despite overall similar en bloc and R0 resection rates comparison to conventional ESD.5 Most recently, a novel dynamic rigidizing overtube (Pathfinder, Neptune Medical, Burlingame, Calif, USA) has been introduced to face the challenges encountered during difficult colonoscopies and to ensure scope stabilization during endoscopic mucosal resection (EMR) and ESD. The overtube material is soft and pliable on flexible state, however when the vacuum is applied the entire tube becomes 15 times stiffer.6 This unique feature of the device provides scope flexibility during colonoscope introduction and entire device stability when rigidizing system is applied.

Our team collected preliminary prospective data of 58 polyps removed by EMR (24.1%) and ESD (75.9% ) with the assistance off rigidizing overtube. Technical success (ability to complete the entire resection using the device) and clinical success (ability of endoscopic removal of polyps without changing the initial resection intent) was achieved 100% and 90% of the time, respectively. On endoscopist feedback, the rigidizing overtube was though to assist in resection in 98.3% of polyps, although the polyp was located in a somewhat/very difficult location 81% of the time. For polyps in difficult locations, the rigidizing overtube was able to maintain scope position without falling back even once, 55% of the time. This result was presented at the most recent Digestive Disease Week conference in Chicago 2023 (p1932).

As this device has been put to use recently in the United States, published literature to demonstrate its safety and efficacy in colonic ESD is lacking. The main aim of this study 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 CA, USA) device in comparison to conventional ESD.

Conditions

Gastrointestinal Neoplasm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Treatment arm

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

Group Type: EXPERIMENTAL

Endoscopic Submucosal Dissection

Intervention Type: PROCEDURE

Removal of study eligible lesions per endoscopic submucosal dissection

Novel Rigidizing Overtube

Intervention Type: DEVICE

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

Control arm

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

Group Type: ACTIVE_COMPARATOR

Endoscopic Submucosal Dissection

Intervention Type: PROCEDURE

Removal of study eligible lesions per endoscopic submucosal dissection

Interventions

Endoscopic Submucosal Dissection

Removal of study eligible lesions per endoscopic submucosal dissection

Intervention Type: PROCEDURE

Novel Rigidizing Overtube

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

Intervention Type: DEVICE

Other Intervention Names

ESD; Endoscopic resection

Eligibility Criteria

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

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baylor College of Medicine

OTHER

Sponsor Role: lead

Neptune Medical, Inc.

UNKNOWN

Sponsor Role: collaborator

Responsible Party

Mohamed Othman, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed Othman, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Baylor College of Medicine

Houston, Texas, United States

Site Status: RECRUITING

Baylor St. Lukes Medical Center (BSLMC)

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Michael Mercado, BS

Role: CONTACT

Michael.Mercado@bcm.edu

713-798-3606

Sara Al Yasin, BS

Role: CONTACT

Sara.AlYasin@bcm.edu

713-798-2308

Facility Contacts

Mohamed O. Othman, MD

Role: primary

Mohamed.Othman@bcm.edu

713-798-0950

Mohamed O. Othman, MD

Role: primary

Mohamed.Othman@bcm.edu

713-798-0950

Michael Mercado

Role: backup

Michael.Mercado@bcm.edu

7137983606

Other Identifiers

H-53924

Identifier Type: -

Identifier Source: org_study_id