Clinical trial · Interventional
Novel Rigidizing Overtube in Colonic Endoscopic Submucosal Dissection
Prospective Single Centre, Post Market, Randomized Controlled Trial to Demonstrate Feasibility, Safety and Efficacy, of a Novel Rigidizing Overtube in Colonic Endoscopic Submucosal Dissection
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Neoplasm | Digestive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic Submucosal Dissection | Procedure | — | UNRESOLVED |
| Novel Rigidizing Overtube | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment arm
- description
- Will have endoscopic submucosal dissection performed with the use of the Pathfinder Endoscope Overtube.
- interventionNames
- Procedure: Endoscopic Submucosal Dissection
- Device: Novel Rigidizing Overtube
- type
- ACTIVE_COMPARATOR
- label
- Control arm
- description
- Will have endoscopic submucosal dissection performed through conventional means (i.e. without the Pathfinder Endoscope Overtube).
- interventionNames
- Procedure: Endoscopic Submucosal Dissection
Primary outcomes (1)
- measure
- Total Procedure Time
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 22 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available