RecruitingNot ApplicableNCT06133387

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

PARADIGM Study: Prospective Assessment of a Robotic Assisted Device in Gastrointestinal Medicine - En Bloc Trial With the EndoQuest Endoluminal Surgical (ELS) System

Sponsor

EndoQuest Robotics, Inc.

Enrollment

56 participants

Start Date

May 13, 2025

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Endoscopic submucosal dissection using the ELS System for people with colorectal adenoma, colorectal lesion, and other related conditions. The study is currently recruiting participants at 6 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEEndoscopic submucosal dissection using the ELS System

All subjects will undergo endoscopic submucosal dissection, with or without closure at the discretion of the Investigator, of benign lesions in the rectum and sigmoid colon.