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NCT06133387 · ClinicalTrials.gov registry record · NA

PARADIGM - En Bloc Trial With the EndoQuest Endoluminal Surgical (ELS) System

A NA study of Colorectal Adenoma and Colorectal Polyp, sponsored by EndoQuest Robotics.

Recruiting
Registry status
NA
Development phase
56
Enrollment target
5
Study locations

NCT06133387 is a NA study of Colorectal Adenoma and Colorectal Polyp that is actively recruiting participants, run by EndoQuest Robotics. The registered enrollment target is 56 participants, below the 1,424-participant average among 8 other Colorectal Adenoma trials with a reported enrollment target (96% lower). The trial reports 5 study locations across 5 states.

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The verdict

NCT06133387, a NA study of Colorectal Adenoma and Colorectal Polyp, is actively recruiting participants, sponsored by EndoQuest Robotics.

RECRUITING
Registry status
NA
Development phase
56 participants
Enrollment target
5
Study locations

Study Summary

The objective of this study is to evaluate the safety and effectiveness of the Endoluminal Surgical (ELS) System in subjects undergoing specified transanal endoluminal procedures in the rectum and sigmoid colon. Subjects will undergo endoscopic submucosal dissection (ESD), with or without closure at the discretion of the Investigator, of benign lesions in the rectum and sigmoid colon. The safety and effectiveness outcomes will be assessed intraoperatively and postoperatively at discharge and Days 7 and 30.

Conditions Studied

Colorectal Adenoma Colorectal Polyp Colorectal Lesion Rectal Lesion Rectal Adenoma Rectal Polyp Sigmoid; Lesion Sigmoid Colon Polyp

Interventions

  • DEVICE Endoscopic submucosal dissection using the ELS System

Study Locations (5)

Arizona

  • Mayo Clinic - Scottsdale

Florida

  • AdventHealth - Orlando

Massachusetts

  • Brigham and Women's Hospital - Boston

Ohio

  • Cleveland Clinic - Cleveland

Texas

  • HCA Healthcare - Houston

Trial Details

FieldValue
Enrollment Target 56 participants
Start Date 2025-05-13
Est. Completion 2026-06
Phase NA

Sponsor

EndoQuest Robotics

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06133387

The ClinicalTrials.gov registry entry for NCT06133387 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,424-participant average among 8 other Colorectal Adenoma trials with a reported enrollment target (96% lower). The listed sponsor is EndoQuest Robotics, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 8 conditions, with Colorectal Adenoma appearing as the primary indexed condition, and to 1 intervention - of which Endoscopic submucosal dissection using the ELS System is the first listed.

NCT06133387 reports 5 study locations spanning 5 distinct geographic areas - top geographies include Arizona, Florida, Massachusetts.

Frequently Asked Questions

What is clinical trial NCT06133387 about?

NCT06133387 is a clinical study titled "PARADIGM - En Bloc Trial With the EndoQuest Endoluminal Surgical (ELS) System". The objective of this study is to evaluate the safety and effectiveness of the Endoluminal Surgical (ELS) System in subjects undergoing specified transanal endoluminal procedures in the rectum and sigmoid colon. Subjects will undergo endoscopic submucosal dissection (ESD), with or without closure at...

What is the current status of trial NCT06133387?

This trial is currently recruiting. It is a NA study. The enrollment target is 56 participants. The study started on 2025-05-13. Estimated completion is 2026-06.

What conditions does trial NCT06133387 study?

This clinical trial studies the following conditions: Colorectal Adenoma, Colorectal Polyp, Colorectal Lesion, Rectal Lesion, Rectal Adenoma.

What interventions are being tested in trial NCT06133387?

The interventions under investigation include: Endoscopic submucosal dissection using the ELS System (DEVICE).

Who is sponsoring clinical trial NCT06133387?

This trial is sponsored by EndoQuest Robotics, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06133387 being conducted?

This trial has 5 study locations across Arizona, Florida, Massachusetts, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.