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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06134687
Other study ID # H-53924
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 6, 2024
Est. completion date July 31, 2025

Study information

Verified date April 2024
Source Baylor College of Medicine
Contact Michael Mercado, BS
Phone 713-798-3606
Email Michael.Mercado@bcm.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Intervention

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

Locations

Country Name City State
United States Baylor College of Medicine Houston Texas
United States Baylor St. Lukes Medical Center (BSLMC) Houston Texas

Sponsors (2)

Lead Sponsor Collaborator
Baylor College of Medicine Neptune Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total Procedure Time Total Procedure Time to perform ESD from scope in to scope out Day 1 (procedure day)
Secondary Navigation Time Total time needed to reach the lesion Day 1 (procedure day)
Secondary Technical Success The ability to complete the entire resection using the device without the need to change to a different tool. This will be marked as either 'yes' or 'no' on the collection report form following the procedure by the research team. Day 1 (procedure day)
Secondary Clinical Success The ability of endoscopic removal of polyps without changing the initial resection intent. This will be marked as either 'yes' or 'no' on the collection report form following the procedure by the research team. Day 1 (procedure day)
Secondary En-bloc, R0, and curative resection rates As collected and measured for each group Day 1 (procedure day)
Secondary Dissection speed during colonic ESD as calculated by cm^2/hr Day 1 (procedure day)
Secondary Closure time Time needed to close area following endoscopic resection Day 1 (procedure day)
Secondary Sedation time Total time patient spent under anesthesia Day 1 (procedure day)
Secondary User-feedback post-procedure Subjective assessment of the degree of difficulty reaching the lesion based on a brief questionnaire given to the endoscopist following the procedure. Day 1 (procedure day)
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