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NCT06134687 · ClinicalTrials.gov registry record · NA
Novel Rigidizing Overtube in Colonic Endoscopic Submucosal Dissection
A NA study of Gastrointestinal Neoplasm, sponsored by Baylor College of Medicine.
- Recruiting
- Registry status
- NA
- Development phase
- 66
- Enrollment target
- 2
- Study locations
NCT06134687: Recruiting NA study of Gastrointestinal Neoplasm, sponsored by Baylor College of Medicine.
NCT06134687 is a NA study of Gastrointestinal Neoplasm that is actively recruiting participants, run by Baylor College of Medicine. The registered enrollment target is 66 participants, below the 100-participant average among 4 other Gastrointestinal Neoplasm trials with a reported enrollment target (34% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06134687, a NA study of Gastrointestinal Neoplasm, is actively recruiting participants, sponsored by Baylor College of Medicine.
- RECRUITING
- Registry status
- NA
- Development phase
- 66 participants
- Enrollment target
- 2
- Study locations
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.
Primary Outcome
Total Procedure Time to perform ESD from scope in to scope out
Conditions Studied
Interventions
- PROCEDURE Endoscopic Submucosal Dissection
- DEVICE Novel Rigidizing Overtube
Study Locations (2)
Texas
- Baylor College of Medicine - Houston
- Baylor St. Lukes Medical Center (BSLMC) - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2024-06-04 |
| Est. Completion | 2025-10-30 |
| Phase | NA |
What NCT06134687 shows while recruiting
NCT06134687 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 100-participant average among 4 other Gastrointestinal Neoplasm trials with a reported enrollment target (34% lower).
The record links to 1 condition, with Gastrointestinal Neoplasm appearing as the primary indexed condition, and to 2 interventions - of which Endoscopic Submucosal Dissection is the first listed.
NCT06134687 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT06134687 about?
NCT06134687 is a clinical study titled "Novel Rigidizing Overtube in Colonic Endoscopic Submucosal Dissection". 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® Endosco...
What is the current status of trial NCT06134687?
This trial is currently recruiting. It is a NA study. The enrollment target is 66 participants. The study started on 2024-06-04. Estimated completion is 2025-10-30.
What conditions does trial NCT06134687 study?
This clinical trial studies the following conditions: Gastrointestinal Neoplasm.
What interventions are being tested in trial NCT06134687?
The interventions under investigation include: Endoscopic Submucosal Dissection (PROCEDURE), Novel Rigidizing Overtube (DEVICE).
Who is sponsoring clinical trial NCT06134687?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06134687 being conducted?
This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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