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

Running, not enrolling · Not applicable

Conditions studied: Colorectal Lesion, Colorectal Adenoma, Colorectal Polyp, Rectal Lesion, Rectal Adenoma, Rectal Polyp, Sigmoid; Lesion, Sigmoid Colon Polyp

In brief

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.

Key facts

Study ID

NCT06133387

Run by

EndoQuest Robotics, Inc.

People needed

56

Starts

2025-05-13

Expected to finish

2026-08-01

Last updated by the study team

2026-07-22

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Mayo Clinic — Scottsdale, Arizona, United States
• AdventHealth — Orlando, Florida, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• HCA Healthcare — Houston, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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