🏛️ Verified NIH Record • Updated 2026-07-20
PARADIGM - En Bloc Trial With the EndoQuest Endoluminal Surgical (ELS) System (NCT06133387)
🔵 Active, Not Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: EndoQuest Robotics, Inc.
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Mayo Clinic — Scottsdale, Arizona
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (6 Sites)
- Mayo Clinic — Scottsdale, Arizona
- AdventHealth — Orlando, Florida
- Brigham and Women's Hospital — Boston, Massachusetts
- Cleveland Clinic — Cleveland, Ohio
- HCA Healthcare — Houston, Texas
- Baylor College of Medicine — Houston, Texas
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.